US Senate Bill will Pressure FDA on Slowing Opioid Approvals

http://nationalpainreport.com/us-senate-bill-will-pressure-fda-on-opioid-approvals-8825956.html

While chronic pain patients continue to worry about what they believe is a decreasing access to certain narcotic pain medications, two U.S. Senators are introducing a bill that would make it more difficult for new and generic opioid drugs to be approved by the U.S. Food and Drug Administration (FDA).

The bill is called the FDA Accountability for Public Safety Act and has been introduced by two West Virginia Senators, Democrat Joe Manchin and Republican Shelley Moor Capito.  Republican Senator David Vitter of Louisiana is also a sponsor.

“This is an American issue,” proclaimed U.S. Sen. Joe Manchin of West Virginia who spoke to the National Rx Drug Abuse Summit on April 8. “When you see Democrats and Republicans come together on an issue like this, I think that should give you some hope.”

In his press release announcing the bill, Manchin said:

“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.”

His Republican counterpart from West Virginia struck a similar theme.

“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,” said Senator Capito.

The bill is a response to FDA’s regulation of opioid painkillers, and specifically one known as Zohydro. The drug was approved in October 2013. The FDA approved the drug despite the advice of its advisory panel, which cited the drug’s potential for abuse when recommending against its approval.

The bill (S. 954) makes the following recommendations:

• 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.

 

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