For an Opioid Non-Interference Clause

  • by: |
  • 04/16/2015

What happened to keeping politics away from science?

Some fine legislators in the World’s Greatest Deliberative Body -- Senators Joe Manchin (D/WVA), David Vitter (R/LA), Shelly Moore Capito (R/WVA) and Tim Kaine (D/VA.) -- have just introduced the so-called FDA Accountability for Public Safety Act. So-called, because these fine legislators do not seem to understand that there is no such thing as a drug that is 100% safe.

Among other items, the legislation would require the FDA to hold advisory committee meetings for all opioids under review and submit a report to Congressional committees explaining why the agency approved an opioid against an advisory committee's vote, including scientific evidence related to patient safety.

Note to fine legislators –“safety” is a relative concept viewed through the perspective of benefit/risk.

The bill also would force FDA to publicly justify its approval of any opioid drugs not recommended by advisory committees for safety reasons. Note to fine legislators – all drugs have risks. Products are not abused because they are “unsafe.”

Many raise the FDA adcomm vote on Zohydro as an example of the agency acting to approve an opioid after a negative committee vote. The soundbite you’ve likely heard is that the vote was against approval of the drug. That’s true. What you probably don’t know is that, by a vote of 11-2, the experts affirmed that there was no evidence to suggest Zohydro had greater abuse or addiction potential than any other opioid.

Note to fine legislators – facts are stubborn things.

The bill also stipulates that the FDA commissioner make a final decision regarding approval of opioids not recommended by the committees due to safety concerns. Note to fine legislators – all approvals are done under the name of the Commissioner – and then testify before Congress if called upon. Really? Can you hear those political sabers rattling?

In addition, the agency would have to disclose any conflicts of interest that may be held by its officials. Do these fine legislators mean the members of advisory committees? If so, this already happens. If they mean FDA staff – then shame on these fine legislators for casting unfair and unfounded aspersions on overworked, underpaid, and deeply committed public health officials.

But wait, there’s more. A sponsor would be prohibited from distributing an approved opioid until FDA submits its report to Congress. After all, these fine legislators are all highly trained scientists capable of judging the issues of crucial importance to the tens of millions of American who suffer from chronic pain.

Perhaps these fine legislators should read the FDA’s “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” which explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. It also makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.

Besides being a bad idea for opioids – the FDA Accountability for Public Safety Act is a slippery slope towards political interference in the drug approval process. If the FDA must defend its approvals of opioids today, will it have to defend its decisions not to approve cancer drugs tomorrow? Should the agency have to explain its decisions to Congress when it approves a drug via an expedited approval pathway too?

Question to fine legislators: What’s next?


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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