InsideHealthPolicy.com’s
FDA Week
an exclusive weekly report on Food and Drug Administration policy, regulation and enforcement
Vol. 20, No. 52 — December 26, 2014
Biosimilar Advisory Meeting May Offer Final Platform For Naming Debate
Stakeholders say an FDA advisory committee meeting in January on the first biosimilar application may offer a key
public forum for debate, and a possible first indicator of where the agency is moving on such contentious policy issues
as naming and data requirements for products going through the health law’s new approval pathway. The panel will take
up the agency’s review and potential approval of Sandoz’s biosimilar of Amgen’s Neupogen, and FDA’s expected preApril decision on the product could establish de facto policy guidelines and influence the World Health Organization’s
next meeting on international nonproprietary names (INN), sources following the issue said.
continued on page 4
FDA Stands Firm On Orphan-Drug Exclusivity Policy Despite Court Ruling
FDA is standing firm on its policy that designated drugs sharing the same indications as previously approved drugs
must show they are clinically superior in order to get orphan drug exclusivity, despite a federal DC district court ruling
that forced the agency to provide exclusivity to a drug it had previously deemed not superior to an identical drug on the
market. One drug attorney described this as a “bold move” by FDA, adding that the ground is fertile if other drug
companies want to bring suit against the agency.
FDA, in a Federal Register notice clarifying its orphan-drug exclusivity policy Tuesday (Dec. 23), says it interprets
continued on page 6
AMA Council Pushes Shared Biosimilar Naming Scheme, Seeks FDA Guide
An American Medical Association internal council report reveals the group is leaning toward a naming scheme
where biosimilars and their reference products share the same International Nonproprietary Names (INN). The report
says that unique names may suggest different active ingredients within the products and go against standard nomenclature. This stance differs from that of the innovator biologics industry and a handful of specialty physician groups, which
argue that shared naming would improperly imply interchangeability (see related story).
The AMA council’s position potentially could boost generic drug makers’ efforts to convince FDA to name
continued on page 8
Sens. Warren, Grassley Push CMS To Require UDIs In Medicare Claims
Ahead of FDA’s rollout of the Global Unique Identifier Database (GUDID), Sens. Elizabeth Warren (D-MA) and
Chuck Grassley (R-IA) sent a letter urging CMS to consider requiring that Medicare claims include Unique Device
Identifier information. While revisions to claims forms are not due for a few years, the move from the Senate duo exerts
pressure on a reluctant CMS to approve a document, being written by a standards committee, that will recommend the
agency change claims forms to include UDIs.
The Accredited Standards Committee X12, a group of representatives from the healthcare system, has convened by
continued on next page
Happy Holidays
The staff of FDA Week would like to wish you
a joyous holiday season and a happy, healthy New Year.
In observance of the holidays, FDA Week will not be published on Jan. 2, 2015.
Your next issue will be dated Jan. 9, 2015.
phone since July to produce recommendations specifically for CMS to include UDI information in claims. The document
was finalized for approval Thursday (Dec. 18) and now moves to another committee for review. Eventually the document
will make its way to CMS for final approval the next time claims forms are updated, projected to be in 2017 or 2018,
sources say.
The senators ask CMS Administrator Marilyn Tavenner to provide answers to 15 questions on how CMS plans to
implement the changes already recommended by the X12 committee. They pointed out that CMS has been a “dissenting
voice within ASC X12 in regards to the incorporation of UDI information in claims.” They said that CMS’s dissent could
deter health plans from using UDI data. They also ask how much money it costs every time CMS revises its forms
requirements and what role CMS plays on the committee.
“We commend the work done by the FDA and ONC, but believe that more needs to be done in order to ensure
that UDIs are also included in claims data,” says the letter, sent Tuesday (Dec. 22). “Claims transactions provide
longitudinal data on patient outcomes across healthcare institutions—a critical capability for implanted medical devices
as problems might not emerge for several years and patients may seek care in facilities that did not perform the implant
procedure,” the letter adds.
The senators maintain that FDA intended for UDI information to be implemented across the entire healthcare
spectrum: from electronic health records kept by provider systems, FDA’s GUDID and claims so patients and providers
could access medical device data in near real-time.
“FDA does not have jurisdiction over what fields are in claims forms, nor over what information is required in order
for a claim to be processed. CMS, however, has the jurisdiction to require that this information be captured for Medicare
claims, and the opportunity to incorporate UDI in claims forms if it will better protect the safety of Medicare beneficiaries,” the letter says.
The senators hint at possible legislation by asking CMS how much it would cost to incorporate UDIs into claims if it
decided to or if it was “mandated to” do so.
The lawmakers give the agency until Jan. 20 to respond.
Meanwhile, the ASC X12 recommendations will move to another workgroup under ASC, which will review the UDI
committee’s documents and then, once approved, move to a technical committee, which will make its recommendations
for digital implementation and send them back to the UDI committee. The second workgroup is scheduled to review the
document on Jan. 8. —David Hood
FDA UDI Database To Go Live In January 2015 By Accepting Accounts
FDA’s database of unique device identifiers will go live for manufacturers in a few weeks, opening the gates for the
massive medical device tracking system to be put in place. Manufacturers will have to open an account with FDA under
the Global UDI Database (GUDID) so they can submit all the information about their devices.
The agency will accept submissions for Class III devices categorized as implantable, life-supporting and lifesustaining (I/LS/LS)starting in January and will subsequently open channels for Class II devices later in 2015, the agency
told stakeholders. The long-awaited database represents a first step by FDA in implementing its UDI-labeling rule, which
gave Class I devices until September to affix a human and machine-readable label on the device.
“We strongly encourage all device labelers to take steps to ensure their readiness to meet UDI requirements well
before actual data submission to GUDID,” the agency said in a statement to stakeholders. “This will provide labelers with
ample opportunity to assess their ability to meet requirements, including data submission to the GUDID, by their deadline
and to work with us if they have any difficulties coming into compliance.”
The database is intended to serve as a reference catalog of information about every FDA-approved device
with a barcode identifier, which will be publicly accessible to allow provider systems, payers, clinicians, patients and
industry to search, download and use information in the GUDID. The idea is for the database to be set up so that hospitals
can scan devices to automatically upload the information. At that point, the data will be merged with a patient’s EHR for
insurance providers. That way, if a device is recalled or is nearing expiration, everyone in the health chain can be notified.
In addition, adverse events could be uploaded and analyzed in near real-time.
Tom Gross, director of the office of Surveillance and Biometrics at FDA’s Center for Devices and Radiological
Health, said the database will be publicly accessible after Jan. 1 as part of FDA’s mandate. Gross said at a conference
hosted by FDA and Pew Charitable Trusts this month that the agency is “pushing on all fronts” to put UDIs into effect,
working with CMS, developing registries for devices, using claims data for public health purposes, advocating EHR
technology for implantable devices and more. “Collectively, it will help us develop a robust postmarket surveillance
system,” said Gross.
But FDA, with its regulatory jurisdiction limited to medical devices, can only urge other agencies to incorporate
UDIs into insurance claims and electronic health records.
The Brookings Institution released a report commissioned by FDA earlier this month analyzing UDI implementation
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FDA Week - www.InsideHealthPolicy.com - December 26, 2014
across the healthcare system. The GUDID, it said, was a cornerstone for all stakeholders.
“For candidate devices that the surgeon might be considering, the surgical suite and/or hospital’s clinical software
could be linked to the facility’s device inventory, to the GUDID, and to other external information via UDIs,” the report
says. “This could enable the surgical staff to have real-time access to unambiguous, accurate, and standardized device
attributes and other relevant information such as recalls or safety alerts.”
Moreover, the database is viewed as key to identifying counterfeit or fake devices. Distributors and provider systems
will be able to detect fraud with the database readily available. Brookings recommended that UDIs work as a component
to verification standards by establishing crosslinks with the GUDID, FDA’s existing Counterfeit Detection Device CD-3
and manufacturer databases for device authentication. According to an FDA report last year, more than half of medical
devices are imported from other countries, increasing the chance they may be fake. The CD-3 instrument is a scanning
device that emits ultraviolet rays to distinguish irregularities in imported medical devices to deem them as false. In
collaboration with the GUDID, the CD-3 could be a powerful cross-referencing tool.
FDA assures patients and manufacturers that no patient information or proprietary information will be available in
the GUDID database. —David Hood
House Staffers Concerned With State ‘Right To Try’ Laws, 10 More Expected
House Energy and Commerce Committee staffers are concerned that “Right to Try” laws enacted by five states and
under consideration by others will dilute the pool of people entering clinical trials, and say the committee’s 21 st Century
Cures initiative may offer alternative ways to quicken patient access to new therapies without sidestepping the FDA
approval process. But the Goldwater Institute, the driving force behind the Right To Try laws, flatly rejects those concerns and expects at least 10 more state bills to emerge in 2015. The group told FDA Week it is ready to litigate if needed
to ensure the state initiatives succeed.
A staffer for the committee raised concerns that patients who are able to get experimental treatments as a result of the
new state laws — which have been passed by Colorado, Missouri, Louisiana, Michigan and Arizona — are being taken
out of clinical trials. The state laws allow seriously ill patients access to experimental drugs outside the FDA approval
process following phase I trials.
However, the Goldwater Institute, which is driving the state initiatives, said Right to Try laws only impact people
who have been given a terminal diagnosis. “Clinical trials are generally really small and people who are terminally ill are
often excluded from the trials,” said a spokesperson for the group. “Because [Right to Try] only impacts people who have
been given a terminal diagnosis, we don’t expect it will impact trials in any significant way.”
Victor Riches, vice president of external affairs at the Goldwater Institute, added that these patients have exhausted
their traditional options, and that the number of these patients is very small. “The probability of diluting the patient pool
would be slim at best,” he said.
The committee staffer told FDA Week that the 21st Century Cures initiative, launched by Chairman Fred Upton (RMI) and Rep. Diana DeGette (D-CO), may propose alternative ways for patients to access needed treatments. The staffer
noted that committee members are looking into making changes to the clinical trials process to speed patient access to
drugs while not undermining FDA’s safety and efficacy standards.
One possible indication of the direction the committee may proceed is legislation this month by Rep. Michael
McCaul (R-TX) that requires drug companies to be transparent in how they make experimental drugs available to certain
patients and requiring critical assessments of FDA’s Compassionate Use program by Congress’ investigative arm and a
stakeholder task force.
But Riches said he is not sure that the federal bill expected to come out of the initiative would do anything to fix the
drug access issues for patients targeted by the state laws, adding that these are people who only have a small amount of
time left.
The group suggests it would be politically difficult for Congress or FDA to try to stop the state initiatives.
If Congress or FDA tries to block these laws, Riches added, the Goldwater Institute has large litigation
experience and would “prevail” in any sort of court setting. “The right to try to save one’s own life is a fundamental
constitutional right,” said Riches. “It’s not the agency’s authority to supersede someone’s constitutional right.”
“If Congress were to do that, they essentially would be telling those patients it would be better to die than to receive
experimental medications,” added Riches. “[The GOP] majority lead in Congress would end very quickly. I don’t believe
that any politicians in Washington, D.C. would want to block these Right to Try laws.”
Currently, the Goldwater Institute expects at least 10 more state bills to be introduced in 2015, including ones in
Texas, Florida and Utah, according to Riches. — Erin Durkin
FDA Week - www.InsideHealthPolicy.com - December 26, 2014
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Eyes Turn To Advisory Meeting . . . begins on page one
The advisory hearing could serve as an important platform for FDA to hear stakeholders’ input on issues such as
biosimilar naming as the agency nears its possible first biosimilar approval, said Michael Reilly, executive director of the
Alliance for Safe Biologic Medicines. The first approval will reveal the agency’s thinking on biosimilar naming as well as
other issues surrounding the data and tests required as part of the review process, he added.
“You have to send signals about your thinking upon approval,” he said.
Dennis Cryer, a physician co-convener of the newly formed Biologics Prescribers Collaborative, also said the first
approval will likely set important policy precedents. The new group sent a letter to FDA Thursday (Dec.18) pushing for
distinguishable biosimilar names.
“Given that FDA has not set formal guidelines surrounding naming, the potential approval of a biosimilar, which
could happen any time after the meeting, will likely set a precedent on naming and establish de facto guidelines on this
issue,” said Cryer.
Cryer also said that the advisory committee meeting will serve as an opportunity for interested stakeholders to offer
public comments on biosimilar naming, even if FDA is not looking for more input in the area. Regardless of what FDA
may say in the interim on naming, the first approval will “unquestionably set a precedent,” he reiterated.
An FDA decision also could influence meetings held by WHO in April on INNs, Reilly said. WHO in July proposed
a naming scheme under which an alphabetic code — separate from the INN — could be assigned to biological active
substances. The biological qualifier (BQ) potentially could be used for labeling, substitution and reimbursement, among
other possibilities, WHO said. WHO weighed in following years of stakeholder input on ways to tackle biosimilar naming
on an international level, but FDA has yet to show its hand (see FDA Week, July 31).
An FDA decision on the first application is expected by April because the Biosimilar User Fee Act sets 10-month
review timeline after the agency accepts an application for review. Under this timeline, the agency has until around March
to complete the review, sources said (see FDA Week, July 24).
The advisory committee meeting will occur almost a month after Sandoz announced its phase III data show the
investigational biosimilar filgrastim demonstrates safety and efficacy similar to Amgen’s Neupogen.
“Sandoz, a Novartis company, announced today Phase III data that demonstrated similarity of its investigational
biosimilar filgrastim compared to the US-licensed reference product, Amgen’s NEUPOGEN (filgrastim), in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy,” the
company stated in a Dec. 8 press release. “The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity.” — Erin Durkin
Senators Ask Agency Heads If They Need Help Limiting Animal Antibiotics
Democratic Sens. Elizabeth Warren (D-MA), Dianne Feinstein (D-CA) and Kirsten Gillibrand (D-NY) sent a letter
on Dec. 15 asking the heads of a newly-formed inter-agency council if they need congressional help as they develop a
national action plan to curb the use or overuse of antibiotics in food animals. President Barack Obama unleashed two
massive reports in September on antibiotics in food animals and tasked the Department of Defense, HHS and Department
of Agriculture to work collaboratively on the new council to tackle the issue.
The trio asked Defense Secretary Chuck Hagel, HHS Secretary Sylvia Burwell and USDA Secretary Tom Vilsack to
provide information on 11 points by mid-January, asking if the council, whom they co-chair, need congressional support
through new legislation or budget measures to ensure the upcoming national plan has all the gaps filled in.
“While the FDA’s policies are a step in the right direction, we are concerned that the FDA may lack the
authority to ensure veterinarians adhere to the criteria for determining an appropriate preventive use laid out in its
guidance documents,” the letter says. The senators go on to say they worry that “FDA does not have a clear mechanism
for collecting the data necessary to evaluate whether its policies effectively reduce the public health threat, and that the
administration has no clear metrics or benchmarks that will be used to determine success or a need for future action.”
The letter marks the second this year on the issue from the three senators; the first was to FDA Commissioner
Margaret Hamburg in July praising her for the agency’s action in addressing antibiotic overuse.
FDA issued two guidances asking pharmaceutical companies to remove growth promotion antibiotics and released a
proposed rule. In the most recent letter, the senators urge FDA to finalize the 2013 proposed rule that would categorize
animal drugs approved for use in animal feed into two classes based on withdrawal periods, limit power to distribute
antibiotic drugs to licensed veterinarians and require stricter labeling procedures, among other provisions.
But the senators caution that FDA’s guidances and proposed rule “may not be sufficient to effectively curtail
the routine use of dangerously low doses of antibiotics for the duration of an animal’s life.” They ask the cabinet
members if the administration needs additional authority from Congress to ensure compliance.
The lawmakers also point to disagreements among stakeholders and competing interests, and ask “what tools
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FDA Week - www.InsideHealthPolicy.com - December 26, 2014
are available to the administration to encourage compliance with FDA criteria for determining an appropriate
preventive use of antibiotics.”
The letter also raises concerns with current data collection efforts. FDA wrote to the senators on Sept. 8 that the
agency doesn’t have a way to collect data on how antibiotics are actually being used in food animal production. And,
while USDA has the authority to conduct voluntary surveys of producers regarding on-farm practices including antibiotic
use, current USDA surveys are voluntary and depend on participation of producers, the senators say. The surveys also
don’t collect antibiotic usage data on indications, route of administration and antibiotic types. The senators ask the agency
heads if the surveys will provide the information needed to evaluate current FDA policies. If not, they add, “(W)hat
agency and department will be tasked with obtaining this data?”
They also question if USDA will set aside enough funding to get the job done. “We understand that the USDA
does not currently have the necessary resources to conduct comprehensive surveys of on-farm antibiotic use practices and
that a large scale study can cost up to $1.5 million,” the lawmakers write. They ask if the administration plans to request
additional funds within current budget caps to perform such a study as part of its fiscal year 2016 budget.
Lastly, the senators ask what “success” means in implementing the policies, since the administration calls for “further
action” if FDA’s efforts are “unsuccessful.”
“It is troubling, however, that neither the FDA nor the administration has given any indication of what would
constitute success of FDA policies and what result would trigger additional actions,” says the letter. “We continue to
strongly believe that clear metrics and benchmarks are needed in order to evaluate the outcomes of policy changes and
determine if future action is necessary to protect public health.”
The three senators gave the agency until Jan. 15 to answer all 11 concerns and questions in the letter, while the
national action plan is due to be released in February. — David Hood
FDA Loosens Rules On Blood Donations From Men Who Have Sex With Men
FDA said Tuesday (Dec. 22) that it will be changing its indefinite deferral policy on blood donations from men who
have sex with men to allow them to make blood donations one year after their last sexual encounter with another man.
The agency said based on the most recent scientific evidence and recommendations from the HHS Advisory Committee
on Blood and Tissue Safety and Availability it will be issuing a draft guidance in 2015 that will allow men who have sex
with men to donate blood after a year of abstinence.
Peter Marks, deputy director for FDA Center for Biologics Evaluation and Research, said the agency has been taking
steps to put in place a national blood surveillance system in conjunction with the National Institutes of Health’s National
Heart Lung and Blood Institute to monitor the effects of the policy change.
“FDA has undertaken a careful examination of the available scientific evidence relevant to its blood donor deferral
policy for men who have sex with men,” Marks said on a conference call with reporters. He said based on Austraila’s —
where the epidemiology of HIV is similar to that in the US — experience and recent studies done on a change in that
country’s deferral policy showed “no adverse effects on the safety of the blood supply with a one year deferral.”
A message on Rep. Sam Farr’s (D-CA) twitter feed hailed FDA’s announcement but said there is still work to do to
getting blood donation bans for gay men fully lifted.
“Lifting the #GayBloodBan is a huge step forward. 1 year deferral shows we still have a lot of work to do moving
toward #equality,” the Twitter post said.
Marks said at this point the scientific evidence does not support going farther than a one year deferral, but FDA will
continue to monitor studies and data for future policy changes.
Other one year deferral policies the FDA has in place are for men or women who have had sex with a person infected
with HIV, intravenous drug users or sex workers.
He said the agency has not moved to allow gay men in committed relationships to donate blood because while one
partner may have been monogamous that person can not guarantee that the other partner has. He said the same reasoning
applies for people in heterosexual relationships
“At this point the scientific evidence does not support self-reported monogamy as a sufficient indicator of reduced
HIV risk,” Marks said. — Todd Allen Wilson
FDA Week - www.InsideHealthPolicy.com - December 26, 2014
5
FDA Firm On Exclusivity . . . begins on page one
the Orphan Drug Act to require the sponsor of a designated drug that is the “same” as a previously approved drug to
demonstrate that its drug is “clinically superior” upon approval in order for the subsequently approved drug to be eligible
for exclusivity.
The policy clarification comes in the wake of the district court case Depomed, Inc. v. United States Department of
Health and Human Services, where Depomed brought suit against FDA when it did not recognize exclusivity for the
company’s drug Gralise.
Gralise, a drug with the active ingredient gabapentin used to treat PHN, shares the same ingredient with Pfizer’s
Neurontin. Depomed argued that its drug was entitled to a seven-year period of marketing exclusivity under the Orphan
Drug Act because it satisfied the requirements by receiving an “orphan drug” designation and FDA’s approval for
marketing.
“The plain language of the exclusivity provision of the Orphan Drug Act requires the FDA to recognize exclusivity
for any drug that the FDA has designated and granted marketing approval, and there is no dispute that Gralise has
satisfied both of those criteria,” the court concluded.
FDA had initially appealed the decision, but withdrew its appeal in November. The agency also states in the Federal
Register notice that the court decision was limited to Gralise.
Hyman, Phelps & McNamara attorneys said FDA’s “double down” of its clinical superiority may be a way to
draw another lawsuit that would give the agency a second chance to draw a favorable court ruling.
“At the time, we thought the decision could have far-reaching implications for FDA’s orphan drug program (and
perhaps beyond),” wrote attorneys Kurt Karst and Michelle Butler in FDA Law Blog. “Indeed, we laid out a bunch of
potential issues in a prior post. But FDA, in the Agency’s ‘clarification of policy,’ pushes all of these concerns to the side
(at least for now).”
Karst told FDA Week that FDA’s move was surprising. “There are already instances that could ripen into another
lawsuit,” he said. — Erin Durkin
FDA’s Electronic Prescribing Rule Goes Against Appropriators’ Wishes
FDA’s release last week of a long-awaited drug electronic labeling proposed rule that would require prescription drug
makers to distribute prescribing information electronically, eliminating the paper form, goes against Senate appropriators’
request earlier this year, but is praised by generic drug makers who tout the electronic labeling plan as an alternative to a
separate generic drug labeling rule they strongly oppose.
The Generic Pharmaceutical Association earlier this year suggested that the electronic labeling rule, which had been
under review at the White House Office of Management and Budget since Aug. 3, 2013, could pose an alternative to the
separate generic drug labeling proposed rule. The second rule would require generic drug manufacturers to unilaterally
update their labels with new safety information, which GPhA asserts would create multiple versions of warning labels
leading to patient confusion. Alternative, GPhA said, E-labeling would allow brand and generic drug companies to update
their labels simultaneously (see FDA Week, April 16).
But the rule drew resistance from the paper labeling industry, which has said FDA lacks the authority to require the
complete replacement of paper labeling for prescription drugs, as well as concerns from community pharmacists.
The electronic labeling rule also goes against requests made by Senate appropriators earlier this year. “[T]he Committee directs FDA to ensure that any proposed regulations regarding electronic inserts of drug labeling does not come in
lieu of paper inserts,” according to report language in an early version of the funding bill.
However, Neas told FDA Week that there is growing bipartisan support for electronic labeling.
FDA’s proposed rule would require that prescribing information be disseminated electronically, and that a
product’s container label and outside package bear a statement directing health care professionals to FDA’s labeling
repository to view the electronic version of prescribing information. FDA says it may grant an exemption from the
electronic distribution of labeling requirements when compliance could adversely affect the safety, effectiveness, purity,
or potency of the drug, is not technologically feasible, or is otherwise inappropriate, according to a Federal Register
notice Thursday (Dec. 18).
The agency says it determined that electronic distribution of prescribing information is better for health care professionals. “FDA has determined that requiring electronic distribution of prescribing information and eliminating the paper
form that is contained on or within the package from which the drug is to be dispensed is important to ensure health care
professionals have access to the most up-to-date information about the safe and effective use of the drug,” stated the
Federal Register notice.
The rule drew immediate praise from GPhA. “While the information received by patients will not change, e-labeling
gives prescribers and dispensers immediate access to the most current, FDA-approved drug prescribing information,” said
Ralph Neas, president and CEO of the Generic Pharmaceutical Association, in a press release. “This means that manufac6
FDA Week - www.InsideHealthPolicy.com - December 26, 2014
turers can provide electronic updates to labels in weeks, rather than the months, or even years, now required for paper
labels.”
But the National Community Pharmacists Association said in general electronic labeling should not be viewed
as an “effective substitute” for paper labeling. The group points to a 2013 U.S. Government Accountability Office
study that found ending paper labeling could adversely impact public health by limiting the availability of drug labeling
to a medium with which physicians, pharmacists and patients might not be comfortable, might find inconvenient, or might
be unavailable.
NCPA also notes that there is no one, agreed-upon website listing uniform drug information; and said shifting to
electronic labeling would impose a cost burden on community pharmacies, which would have to print upon request
prescription labeling that is now provided by drug manufacturers. The group is in the process of reviewing the rule.
FDA provided some details as to how the rule would affect manufacturers and pharmacies. “After initial set-up
costs, industry will experience net savings by providing the prescription information electronically,” said the agency.
“Pharmacies will incur net costs due to initial capital costs to access the information, increased search time when accessing the information and the printing cost when a request is received for the prescribing information in printed form. We
estimate no cost increases to most health care professionals to access the information.”
The Biotechnology Industry Organization (BIO) is also in the process of reviewing the rule, but in the past has
pushed for its release.
The group referred to a letter it sent to OMB at the beginning of 2014 stating paperless labeling would improve patient
safety and that there are significant cost savings associated with e-labeling that would generate a positive economic impact.
“E-Labeling will have clear benefit for the public health by providing timely access to new safety information and
can make a positive impact on the environment by reducing unnecessary waste,” the group says. — Erin Durkin
Companies Push For Predictability In Naming System Over Reservations
Teva Pharmaceuticals is warning FDA that drug companies could potentially abuse a program for the “reserving” of
proprietary names, and the Pharmaceutical Research and Manufacturers of America is urging FDA to add more predictability to applicants rather than setting up a proprietary name reservation system.
The agency in July opened a public docket to discuss the possibility of reserving proprietary names for companies
once the names have been tentatively accepted by the agency. This initiative was included in the Prescription Drug User
Fee Amendment IV goals letter.
In a Federal Register notice, FDA said stakeholders have indicated that the existing process does not provide
applicants with sufficient certainty prior to approval of their application that a proposed proprietary name will be included in approved drug labeling.
Teva says it supports the concept of reserving proprietary names for drug products but warns that limitations are
needed to mitigate potential abuse by companies, such as attempts to put many names on hold to block competition or
make a business out of it.
“An example of potential abuse would be companies charging other pharmaceutical companies to obtain a
name after reserving many more than necessary,” says Teva. “To prevent such cases, only pharmaceutical companies
who submit proposed names with preliminary research have submitted their IND should be considered.”
Teva also pushes for such a program to be mapped out for clarity, a point supported by the Consumer Healthcare
Products Association (CHPA).
“In principle, CHPA members support the concept of an early approval program for proposed proprietary drug names
(early approval program),” says the group. “However, should FDA decide to implement an early approval program, we
expect that FDA would publish a draft Guidance for Industry and we would provide further comment based on the criteria
outlined by the Agency.”
But PhRMA and Novartis Pharmaceuticals Corporation urge FDA to improve the current process in lieu of setting up
a name reservation program.
PhRMA in 2009 submitted a proposed draft guidance on this topic, but the group says its current thinking has been
informed by policy and procedural developments. The group says it supports the Center for Drug Evaluation and
Research’s elimination of the pre-action name review and urges the agency to formalize this new practice and apply it to
the Center for Biologics Evaluation and Research.
The group also pushes FDA to provide formal guidance to sponsors regarding their options when the agency “conditionally rejects” a proposed proprietary name and recommends that when the agency rejects a name it communicate
regularly with the sponsor about the agency’s thinking during the remaining proprietary name review process.
Novartis also proposes a procedural enhancement whereby FDA would conduct a single proprietary name review and
eliminate the multiple review system that currently occurs any time after phase II of the investigational new drug application (IND) and again at NDA/BLA filing. — Erin Durkin
FDA Week - www.InsideHealthPolicy.com - December 26, 2014
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AMA Council Pushes Shared Naming . . . begins on page one
biosimilars after products they copy. The naming issue is viewed as one of the most contentious policy issues yet to be
resolved as FDA nears a decision on whether to approve what would be the country’s first biosimilar.
AMA’s Council on Science and Public Health raises concerns surrounding unique naming for biological products,
saying that nonidentical INNs may suggest to prescribers that the active ingredient in products is different; create the
impression that interchangeable biosimilars have important, clinically relevant distinguishable effects; and reduce uptake
and substitution of interchangeable biosimilar products.
The council’s overall recommendation was that AMA urge FDA to finalize guidance on the naming and labeling
conventions to be used for biosimilar products, including those that are deemed interchangeable — a recommendation
endorsed by AMA. The council report adds that any change in current nomenclature standards should be informed by a
better understanding of how this would impact prescriber attitudes and patient access.
But the council’s report goes a step further and raises concerns with nonidentical INNs. “Actions that solely enhance
product identification during surveillance but act as barriers to clinical uptake are counterproductive,” says the council
report. “However, because of unique product attributes, a relatively simple way to identify and track which biosimilar
products have been dispensed to individual patients must be established. If unique identifiers for biosimilar [United States
Adopted Names] are required to support pharmacovigilance, they should be simple and the resulting names should
reinforce similarities by using the same root name following standards for nonproprietary names established by the
USAN Council.”
AMA’s council notes the World Health Organization’s plan, which was unveiled during the summer, and includes a
unique identifier process for biologics. “It is critically important that the FDA issue guidance on the naming of biosimilar
products in the United States,” the group says. “Adoption of different naming conventions for biosimilar products could
contribute to confusion, bearing in mind that adverse events also are reported to U.S.-based companies from foreign
physicians and health care providers.”
The council says it has a unique perspective on the issue because AMA administers the United States Adopted Names
(USAN) in collaboration with the American Pharmacists Association and United States Pharmacopeia (USP), with FDA
representation.
“The FDA retains the statutory authority to establish a different non-proprietary name than that designated by USP,
but can do so only through notice and comment rulemaking and has never exercised this authority,” states the AMA
council’s report.
The council also explains that USP has the authority under the Food, Drug and Cosmetic Act (FDCA) to develop
official nonproprietary names for drugs and biologics, and any drug with a name recognized in the USP National Formulary must comply with compendial standards for strength, quality and purity.
“[A]ny drug substance or drug product that meets the identity test in a monograph must use the compendial name and
meet monograph standards for strength, quality and purity,” states the report. “In other words, if USP develops a monograph for a biologic product, any biosimilar product that meets the identity test in this monograph should have the same
nonproprietary name according to USP.”
The document notes that both USAN and INN identify an active substance and were designed to be shared
among products rather than to identify a specific product. “Different USANs or INNs denote products with different
active ingredients, and the prevailing view until recently has been that they should not be used to differentiate products
with the same active ingredient when evidence is available to conclude that no relevant pharmacologic or clinical differences exist,” the council states.
In the role of pharmacovigilance, the group says that the INN is one piece of information in a comprehensive
identification system for products, and allows for the aggregation of post-marketing data across brand and related generic
drugs, where the INN facilitates the detection of safety signals associated with an active ingredient.
AMA points to the American Society of Health-System Pharmacists that says the current U.S. standard nomenclature,
the National Library of Medicine’s RxNorm, uses common root names to normalize group products that “conceptually are
equivalent.”
However, there is a lack of robust data to inform how physicians would interpret identical or non-identical nonproprietary names of biosimilars, and reliable predictions or recommendations cannot be made on how naming conventions may
influence prescriber behavior, the report says. — Erin Durkin
8
FDA Week - www.InsideHealthPolicy.com - December 26, 2014
Express Scripts Gets Discount On AbbVie’s Hep C Rx
Express Scripts will only include AbbVie’s hepatitis C drug Viekira Pak on its National Preferred Pharmacy formulary in exchange for a “significant” discount on the drug, an Express Scripts spokesman said, and there will be no
restrictions to access for the 25 million people on that formulary. Biotech analysts for J.P. Morgan believe the deal marks
the beginning of pharmacy benefit managers using exclusionary formularies to cut drug prices.
Since Gilead Sciences priced Sovaldi at $84,000 for a 12-week course a year ago, policymakers have debated
whether competitors would drive down the price of hepatitis C drugs. The history of so-called me-too drugs didn’t bode
well for price competition, many said, but others insisted that once other drugs came on the market, plans and pharmacy
benefit managers would secure rebates, avoiding the need for government price controls.
Express Scripts Chief Medical Officer Steve Miller told Inside Health Policy last month that the company planned to
get makers of competing hepatitis C drugs to significantly undercut Gilead on price in exchange for Express Scripts
steering market share their way.
A J.P. Morgan investor note states that the deal shows that PBMs can lower drug costs, and “this is just the beginning.”
“Recall that both Express Scripts and CVS/caremark have introduced exclusionary formularies over the past few
years. While hepatitis C is garnering a significant amount of attention, given increased competition in other larger
therapeutic classes on the specialty side, we believe there now exists a significant opportunity to drive discounts where
several products are determined to be at least clinically equivalent,” the J.P. Morgan note states, adding that biosimilars
also might offer PBMs the opportunity to use exclusionary formularies.
Viekira Pak is the first interferon-free competitor to Gilead’s Harvoni, which is the second-generation version
of Gilead’s Sovaldi. Sovaldi is indicated for use with interferon, which makes patients very sick, although some
patients were cured by combining Sovaldi and Johnson & Johnson’s Olysio, which together cost about $150,000.
Harvoni is a once-daily pill that is taken without other drugs and cures nearly everyone who takes it. Its price is
$94,500. Viekira Pak costs $83,319 and doesn’t require interferon, but the regimen is more complicated at four to
six pills each day.
However, Express Scripts is getting a significant discount on the Viekira Pak. Express Scripts spokesman Brian
Henry declined to disclose the level of discount, other than to call it “significant.” He also said AbbVie’s blockbuster
rheumatoid arthritis drug Humira was not bundled into the deal.
State Medicaid plans and commercial insurers have been restricting access to Harvoni and Sovaldi by only allowing
the sickest patients to receive them, and patient advocates are considering suing over those restrictions. The discount on
Viekira Pak is significant enough that Express Scripts is covering it for anyone who tests positive for the infection, even if
they’re not showing symptoms of infection, which can take decades to manifest.
Henry said patients may appeal to get access to other, more expensive hepatitis C drugs if their physicians insist that
they need them. He also noted that Express Scripts Pharmacy & Therapeutics Committee determined Viekira Pak to be
clinically equivalent to Harvoni and Sovaldi. Henry said the committee met Friday and Saturday following FDA’s
announcement of Viekira Pak’s approval. However, AbbVie had been sharing clinical information on the drug with the
committee for a long time in anticipation of approval, he added.
FDA approved Viekira Pak to treat hepatitis C genotype 1 only. Genotype 1 accounts for about 75 percent of infections in the United States. Express Scripts will cover Sovaldi for patients infected with other genotypes.
Express Scripts is responsible for the pharmacy benefits of about 85 million people. Henry said Express Scripts is
using the deal with AbbVie to get some of its other clients to join the National Preferred Pharmacy formulary, which
covers 25 million people.
Evercore ISI biotech analyst Mark Schoenebaum wrote in an investor note that Express Scripts is using the deal to
negotiate a lower price from Gilead on Harvoni and Sovaldi, and he said Gilead believes that there is room to renegotiate
its contract with Express Scripts.
Schoenebaum estimated the Express Scripts deal takes 2 percent to 7 percent of Gilead’s hepatitis C market.—
John Wilkerson
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FDA Week - www.InsideHealthPolicy.com - December 26, 2014
9
Second Interferon-Free Hep C Rx Costs $83,319; Close To Price of Sovaldi
FDA approved the second hepatitis C drug for use without interferon, called Viekira Pak, and AbbVie is charging $83,319
for a 12-week course of the drug, a company spokesperson said, compared to the $94,500 12-week price of Gilead Science’s
Harvoni and the $84,000 price of Harvoni’s predecessor Sovaldi. Medicaid directors and health plans anxiously awaited the
approval of Viekira Pak in the hopes that AbbVie would significantly undercut the price of Gilead’s hepatitis C drugs.
Despite the official price tag on Viekira Pak, an analyst said it would not be surprising if AbbVie offers rebates to get
the drug on formularies.
Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that inhibit the growth of HCV. It
also contains ritonavir, a previously approved drug, which increases blood levels of paritaprevir. Viekira Pak can be used
with or without ribavirin, but it is not recommended for patients whose liver do not function properly, a condition called
decompensated cirrhosis.
FDA Director of the Office of Antimicrobial Products Edward Cox said Viekira Pak is the latest in a wave of drugs that has
made curing the infection much easier. “We continue to see the development of new all-oral treatments with very high virologic
response rates and improved safety profiles compared to some of the older interferon-based drug regimens,” Cox said.
However, one company, Gilead Sciences, has dominated the market, and health plans and Medicaid directors are up
in arms over the price the company’s drugs. (Several other health care sectors, including hospitals, physicians, unions,
disease advocacy groups and the nation’s largest seniors group, AARP, have also joined a campaign against the price of
Gilead’s drugs.) FDA first approved Sovaldi in December 2013, then this fall it approved the second-generation version
called Harvoni, which is approved for use without interferon or other drugs. Sovaldi was approved for use with interferon, which makes people sick, but doctors often prescribe Sovaldi with Johnson & Johnson’s Olysio, even though FDA
did not approve the drugs in combination, and the drugs together cost about $150,000.
Harvoni costs $94,500 for a 12-week course. Those who are less sick can take an eight-week course for $63,000 so
Gilead says the “average” price for Harvoni is $80,000. However, John Rother, who leads the Campaing for Sustainable
Rx Prices, said many health plans and Medicaid programs are treating only sicker patients so it’s uncommon for patients
to receive the shorter course.
The shortest course for Viekira Pak is 12 weeks, said AbbVie Director of External Communications Adelle Infante.
Very sick patients may need a 24-week course, depending on physician discretion, but the company expects that only a
small population of patients would need the longer course. Infante did not know the price of the 24-week regimen.
Viekira Pak’s regimen requires patients to take four to six pills each day, which is more complicated than the oncedaily pill Harvoni. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams
(mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily. Patients with advanced liver damage
must take an extra medicine, ribavirin, which adds two more pills to the regimen.
The Centers For Disease Control and Prevention estimates that 3.2 million Americans are infected with hepatitis C.
Others say that estimate is low.— John Wilkerson
CMS: Study Reinforces Concerns About Urban Preferred Pharmacy Access
CMS officials said Tuesday (Dec. 16) a recent analysis of beneficiaries’ convenient access to lower cost sharing in
plans’ preferred pharmacy networks shows that plans in suburban and rural areas generally provide convenient access to
lower cost sharing but some aren’t providing convenient access in urban areas. CMS said the results of the study reinforce
the agency’s concerns around access to preferred pharmacies, but some following the issue says the study appears
incomplete as it looks at the number of plans providing convenient access to lower cost sharing and doesn’t lay out how
many beneficiaries are affected when plans don’t provide such lower cost sharing.
The study drew praise from community pharmacists, but pharmacy benefit managers raised alarms that CMS may be
revisiting its prior plan to impose new pharmacy access requirements that PBMs view as violating the law’s ban on CMS
interfering with plans’ price negotiations with pharmacies.
A CMS official said the agency is considering future policy options, and though CMS’ next steps haven’t yet been
decided further plans will be outlined in a draft Medicare Advantage and Part D call letter. While those plans could come
as soon as the 2016 draft call letter, she also said the agency might wait until later years.
“While we appreciate the importance of providing lower costs to beneficiaries, these findings reinforce CMS’
concern that plans are offering access to pharmacies with lower cost-sharing in a way that may be misleading to beneficiaries, in violation of CMS requirements,” according to CMS slides presented on a webinar with stakeholders Tuesday.
The agency says it plans to provide Medicare Part D and Medicare Advantage plans with information about
whether they are meeting the benchmarks CMS used in the study to show convenient access, and hold discussions with
those who aren’t. CMS says it will look more closely at plans providing low levels of convenient access to preferred cost
sharing in urban, suburban and rural areas and will also continue monitoring complaints and access levels.
Though CMS released the results of the study Tuesday and will have another webinar on the study Wednesday (Dec.
10
FDA Week - www.InsideHealthPolicy.com - December 26, 2014
17), an agency official said the final report will not be published until after Jan. 1.
The agency said in the 2015 Medicare Advantage and Part D Call Letter it was concerned about beneficiaries’ access
to preferred pharmacy networks. CMS had earlier planned to open these networks to any pharmacy willing to offer drugs
at similar prices to the preferred networks’ terms, but pulled back its proposal, along with other aspects of the controversial Part D rule proposed in January, 2014, and the provision was not included in a final version of the rule.
In the 2015 Call Letter, however, CMS said it was still concerned about beneficiaries’ access to the lower costsharing available at preferred pharmacy networks and their understanding of the preferred cost-sharing arrangements.
CMS’ study took the standard for convenient access to retail pharmacies, and applied them to preferred pharmacy
networks — though the agency noted that there is no current regulation that guides access to preferred pharmacies that
offer lower cost sharing. However, an agency official said the standard for convenient access to retail pharmacies provided a reference point for meaningful access.
The study said that for urban areas, convenient access meant 90 percent of beneficiaries have access to pharmacies
within two miles of where they live, 90 percent of suburban beneficiaries have access within five miles of their homes,
and 70 percent of rural beneficiaries have access within 15 miles of their residence. The study looked at Medicareeligible beneficiaries, and the distance between where they live and both in-network and preferred network pharmacies.
On average, CMS notes that access to a pharmacy offering preferred cost-sharing in suburban and rural areas goes
beyond the convenient access standards CMS applied in the study. But on average, only 79 percent of urban beneficiaries
the study looked at had access to a pharmacy offering preferred cost sharing within two miles. CMS said 54 percent of
plans did not meet the convenient access standard for preferred pharmacy networks in urban areas, though the overwhelming majority of plans met those standards in suburban and rural areas (87 percent and 95 percent respectively).
CMS’ slides say that “urban access is a problem,” and of the plans not meeting the 90 percent standard, 16 percent of
those provided convenient access to less than 30 percent of their beneficiaries in urban areas.
Some stakeholders on the webinar took issue with CMS’ study, noting that the agency was judging access to pharmacies in preferred pharmacy networks on regulations that don’t apply. But the National Community Pharmacists Association said the preferred networks “have been the proverbial ‘Wild West’ with no consumer safeguards.”
NCPA said it appreciates CMS’ conclusion that the findings reinforce the agency’s concerns.
But the Pharmaceutical Care Management Association, which represents PBMs, said the study “should raise
a new round of questions from policymakers” about CMS’ plans to make changes to plans with preferred cost sharing.
Among those are whether the study is “a pretext for new CMS pharmacy access requirements in 2016” and if the agency
has the authority to require those without new regulation. PCMA also questions whether such requirements would violate
non-interference, since they would impact plan negotiations with pharmacies.
PCMA also questioned whether new access standards would force plans to add new preferred pharmacies even if
they don’t offer the same cost savings. The group also asks if CMS will brief Congress on the study and any proposed
action plan when they return in January, given the controversy around the preferred pharmacy networks proposal in the
Part D rule proposed in January 2014.
CMS was also asked on the webinar if it plans to look at how many beneficiaries are affected by the plans that don’t
meet the convenient access benchmarks used in the study, and one lobbyist following the issue said that without knowing
how many beneficiaries are affected, the study seems incomplete. Another industry lobbyist said the number of beneficiaries in those plans could skew the results of CMS’ study in a big way.
A CMS official said the agency would consider enrollment weighting the results of the study for future analyses. — Michelle M. Stein
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FDA Week - www.InsideHealthPolicy.com - December 26, 2014
11
Some Doctors Push Distinct Biosimilar Names, Breaking From AMA Stance
A handful of specialty physician groups are siding with the innovator biologics industry in urging FDA to adopt a
biosimilar naming scheme under which products have distinguishable names, pushing back against arguments made by an
American Medical Association council and generic drug makers for shared International Nonproprietary Names (INNs).
The groups, like innovator companies, argue that distinct names are needed to track adverse events and to protect against
improper pharmacy substitution.
The specialty physician groups wrote to FDA Thursday (Dec. 18) that a shared name would imply interchangeability,
referencing statements made by the agency in past about how INNs should not be used to “imply pharmacologic interchangeability of products with the same active ingredient(s).”
Signers of a the letter include: Alliance for Patient Access; American Academy of Allergy, Asthma & Immunology;
American Association of Clinical Endocrinologists; American College of Rheumatology; American Gastroenterological
Association; Association of Black Cardiologists; American Urological Association; Clinical Immunology Society;
Coalition of State Rheumatology Organizations; physician co-conveners Biologics Prescribers Collaborative; and
members of the National Physicians Biologics Working Group of the Alliance for Patient Access.
This stance goes against an AMA council’s position that INNs are designed to identify the active substance and to be
shared among products rather than identify a specific product, according to a summary of AMA’s recent meeting where
the issue came up. AMA adopted recommendations from its Council on Science and Public Health urging FDA to
finalize guidance and stating: “Any change in current nomenclature rules or standards should be informed by a
better and more complete understanding of how such changes, including requiring a unique identifier for biologic
[United States Adopted Names] would impact prescriber attitudes and patient access, and affect post marketing
surveillance. Actions that solely enhance product identification during surveillance but act as barriers to clinical
uptake are counterproductive.”
The generic drug industry has also argued against distinct biosimilar names.“Adding more complexity to current
naming is NOT recommended as it will neither increase compliance nor reduce confusion,” according to slides presented
by the Generic Pharmaceutical Association at a meeting with FDA. The group also references arguments made by the
National Council for Prescription Drug Programs in favor of shared names (see FDA Week, Aug.14).
But the physician groups in their Dec. 18 letter argue the opposite: Having biosimilars share names with their
reference products would create confusion. The groups note that INNs are used to identify products in the case of adverse
events, and argue that shared naming could make tracking drugs that cause adverse events difficult. The group also points
out that some international regulatory systems have proposed to distinguish biosimilars by name, referencing the World
Health Organization’s recently proposed “biological qualifiers” for all biologic qualifiers.
The letter also takes issue with arguments by generic drug makers that if FDA requires distinct INN for biosimilars,
the agency should require the same whenever a pioneer product undergoes manufacturing changes. “While creative, this
argument makes a meaningless comparison,” state the groups. “The process a pioneer product must go through to prove
that a post-approval manufacturing change results in a comparable product is not the same as the premarket approval
process a biosimilar will go through to obtain authorization to market.”
The groups say resolution of the naming issue will determine the answers to other outstanding regulatory
questions surrounding biosimilars. They note that the Biologics Price Competition and Innovation Act (BPCIA)
contemplates two levels of sameness: biosimilarity and interchangeability.
“[A] shared INN may ‘preempt’ the two other major remaining regulatory questions: what will be required for a
showing of interchangeability and whether the biosimilar will be allowed to extrapolate between the indications,” the
letter states. “Assign the biosimilar a shared INN and, de facto, many patients, physicians and pharmacists may assume
interchangeability and shared indications.”
Dennis Cryer, a physician co-convener of the Biologics Prescribers Collaborative, said that WHO’s approach would
be a large help in the area of unique names, but clarifies it is hard to tell whether the biological qualifier will be enough.
However, a recently formed patient coalition, Patients for Biologics Safety & Access, says WHO’s scheme falls short
and argues that biosimilars should have completely separate names from their originator products (see FDA Week, Nov.
6).
The WHO unveiled a naming scheme over the summer that would add biological qualifiers — an alphabetic code —
to the INN.
The specialty physician groups weigh in as eyes are turning to the advisory committee meeting of the first biosimilar
application, Sandoz’s filgrastim application, a copy of Amgen’s Neupogen, as an indication of where FDA will be
heading in terms of naming and other questions surrounding data. — Erin Durkin
12
FDA Week - www.InsideHealthPolicy.com - December 26, 2014