FDA Accountability for Public Safety Act Manchin Letter

 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
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.
Kyle Simon
Director of Policy and Advocacy