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Capito Statement On Legislation To Hold FDA Accountable For Approving Opioid Drugs
SHELLEY MOORE CAPITO/UNITED STATES SENATOR FOR WEST VIRGINIA/Wednesday, April 15, 2015
Click For senate.gov Link




WASHINGTON, D.C. -- U.S. Senator Shelley Moore Capito (R-W.Va.) today joined with Senators Joe Manchin (D-W.Va.) and David Vitter (R-LA) to introduce the FDA Accountability for Public Safety Act. Senator Capito released the following statement about the legislation, which would hold the Food and Drug Administration (FDA) accountable for opioid drugs approved by the agency:



“West Virginia’s drug epidemic has claimed far too many lives of our friends, neighbors and children. We must bring more accountability to the FDA and ensure that consumer safety is the number one priority when new, dangerous opioid medications are considered. I am proud to join with Senators Manchin and Vitter to introduce this critical legislation that will bring us one step closer to wiping out the scourge of drug addiction harming our nation’s communities.”



To read the full text of the bill, please CLICK HERE.



The FDA Accountability for Public Safety Act:



* Holds FDA Accountable for Opioid Drugs Approved: Requires a measured response to ensure that the experts’ voices are heard when the FDA is considering new, dangerous opioid medications.


* All opioid medications would be subjected to advisory committee review and recommendation before the FDA makes a decision on approving an opioid.


* If the Advisory Committee does not approve of an opioid medication due to concern over consumer health and safety – just as the Committee acted with respect to Zohydro – the FDA Commissioner would be required to make the final decision regarding drug approval; currently, the FDA Commissioner does not need to act when the Advisory Committee is overruled.


* The FDA must submit a report to the Chair and Ranking Member of the relevant Committees that includes medical and scientific evidence regarding patient safety and clearly justifies why they ignored the Advisory Committee’s recommendation. The report must also include any conflicts of interest that FDA officials involved may have. Finally, the FDA is required to submit a copy of this report to any Member of Congress who requests a copy.


* At the request of the appropriate congressional committee, the FDA Commissioner would be required to testify before Congress as to why the FDA ignored its own Advisory Committee.


* Distribution of the drug would be prohibited until the report is submitted to Congress.


Background:



The FDA advisory committee consists of the best healthcare experts, doctors, and scientists in their respective fields. Under the FDA’s own regulations, the agency must convene an advisory committee when a matter is of significant public interest, highly controversial, or in need of a specific type of expertise. Given the danger of abuse and overdose death, it is clear that the approval of new opioid drugs meets each of these standards, which would compel the FDA to organize an advisory committee.



In recent years, however, the FDA has either ignored its advisory committee’s recommendations or failed to seek its counsel in the first place. In 2013, the FDA approved the very powerful opioid, Zohydro, despite the advisory committee voting 11-2 against approval of the drug due to their concerns about the safety of the drug.



Since that time, the significant negative feedback that the FDA has received on that decision has led the FDA to avoid the advisory committees altogether despite the fact that opioids clearly fall within the FDA’s own guidelines for when to seek an advisory committee opinion. Since Zohydro, two new opioid medications, Targiniq and Hysingla, have been approved without an advisory committee meeting.



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