May 5, 2015 Senator Joe Manchin United States Senate 306 Hart Senate Office Building Washington, D.C. 20510 Dear Senator Manchin: The not-for-profit Center for Lawful Access and Abuse Deterrence (CLAAD) writes to express our concerns regarding the FDA Accountability for Public Safety Act (FAPSA, S.954). CLAAD is a national, not-for-profit organization working to reduce prescription drug abuse while protecting patient access to care. Since 2009, CLAAD’s National Prescription Drug Abuse Prevention Strategy has encouraged a balanced approach to the prescription drug abuse epidemic. The National Strategy has earned the endorsements of over 30 organizations, including the Drug Free America Foundation, National Family Partnership, the American Chronic Pain Association, and NAADAC – the Association for Addiction Professionals. CLAAD is concerned that FAPSA will not be a beneficial tool for addressing opioid abuse in a meaningful, balanced way. Enactment of this bill has the potential to slow innovation and the adoption of abuse-deterrent formulations (ADFs) in the marketplace, as well as hinder consumer access by requiring the Food and Drug Administration (FDA) to prohibit distribution of an agencyapproved medication. S.954 fails to recognize that the FDA entails extensive evaluation by experts objectively committed to public health and safety. Giving advisory boards veto authority over FDA decisions places the medication approval process at grave risk for politicization and commercial interference. FAPSA harkens back to the October 2013 approval of a hydrocodone product that did not contain acetaminophen, an ingredient that can cause liver damage. FDA approved the medication, which does not have abuse-deterrent properties, despite an advisory committee contrary recommendation, which led to efforts by federal and state policy makers to ban the medication. The U.S. District Court for the District of Massachusetts overturned the Commonwealth’s ban based on its finding that the medication yielded no greater harm than other opioid medications in its class of controlled substances. Moreover, post-marketing experience supports the federal court’s conclusion. It should also be noted that the manufacturer of the medication has since voluntarily replaced the original product with a new version that is intended to be abuse-deterrent. As demonstrated in the hydrocodone case, the FDA evaluates medications based on objective scientific and medical risk-benefit analyses, which have the potential to be challenged on political or commercial grounds if Congress passes FASPA. Giving a citizen panel whose function is meant to be advisory effective veto authority over the FDA undermines an otherwise objective, non-political, non-commercial process. Panel members who subjectively oppose certain medical treatments or have undisclosed commercial relationships could purposely delay a medication’s approval to advance their own interests rather than those of consumers in need. Center for Lawful Access and Abuse Deterrence 1000 Potomac Street NW, Suite 150-A • Washington, D.C. 20007 • (202) 599-8435 • www.CLAAD.org • @CLAAD_Coalition CLAAD appreciates your leadership and desire to make opioid abuse deterrence a priority; however, it is our view that FAPSA will create more problems than it solves. Thank you for taking into consideration our comments. Please contact us at (202) 599-8435 or at [email protected] if you have any questions or if we can be of service to your office. Sincerely, Kyle Simon Director of Policy and Advocacy 2