April 15, 2015

Manchin Introduces Bill to Hold FDA Accountable for Approving Dangerous, Addictive Drugs

Senators introduce ‘FDA Accountability for Public Safety Act’

Washington, D.C. – U.S. Senator Joe Manchin (D-W.Va.) and David Vitter (R-LA) today introduced the FDA Accountability for Public Safety Act, which would hold the Food and Drug Administration (FDA) accountable for opioid drugs approved by the agency. The legislation would ensure that experts’ voices are heard when the FDA is considering new, dangerous opioid medications. Senator Shelley Moore Capito (R-W.Va.) is also an original cosponsor.

“With 46 people dying every day from an overdose of prescription drugs across this country, it only makes common sense for the FDA to seek the advice of its expert panel and follow its recommendations concerning the approval of dangerously addictive drugs for public use,” Senator Manchin said. “Regrettably, the FDA has proven time and time again that it is willing to ignore its own experts and approve medications that harm consumers. This is deplorable and unacceptable. Too many lives have been lost, too many families have been torn apart, and too many communities have been affected by these potent painkillers. I am proud to continue fighting this growing epidemic by introducing commonsense legislation that takes another step toward making sure the drugs our government validates are safe.”

“Consumer safety needs to be our top priority, and we can ensure it is by increasing accountability at the FDA,” said Senator Vitter. “Specifically, additional review will increase accountability in the approval process for medications and protect against any conflicts between the FDA, pharmaceutical companies and expert panels.”

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.


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.