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Outrage of the Month: FDA Joins Hands With Industry to Weaken Agency’s Rules

Health Letter, January 2016

By Michael Carome, M.D.


If you’re not outraged,
you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

Image: Dirk Ercken/Shutterstock.com

In a Dec. 10, 2015, exposé, Inside Health Policy (IHP) revealed details of an Aug. 7 high-level strategy meeting between the Food and Drug Administration (FDA) and the medical device industry. An FDA background document for the August meeting, obtained by IHP, stated that FDA representatives and AdvaMed, a leading medical device trade association, had worked together on proposed language for the medical device provisions in the 21st Century Cures Act, which the House of Representatives passed on July 10. The document further revealed that the FDA and AdvaMed were working together on a Senate version of the bill.

FDA attendees included Dr. Stephen Ostroff, acting FDA commissioner; Dr. Robert Califf, a deputy FDA commissioner and the current nominee to serve as FDA commissioner; and Dr. Jeffery Shuren, director of the FDA’s medical device division. Industry attendees included the president of AdvaMed and senior officers from three leading medical device companies. A meeting summary stated that AdvaMed thanked Shuren and his team “for meeting with AdvaMed regularly during the legislative process for getting the 21st Century Cures Act passed by the House of Representatives.”

It should be unimaginable that FDA leaders would collude with AdvaMed to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The resulting House bill would eviscerate the already far-too-weak safety rules for medical devices. Similar legislation is now being crafted by the Senate.

Defending its collaboration with AdvaMed in drafting legislation chock-full of provisions on the device industry’s wish list, the FDA told IHP that the agency’s meetings with the industry trade group were “standard procedure” and that “Congress requested technical assistance from FDA on the legislation.” Yet while industry has the right to lobby Congress directly, it is unseemly and unacceptable for the FDA to collaborate with regulated industries in drafting laws that would directly affect the regulatory oversight of those industries. No one from the FDA should have been involved in such a process, which violates the most elementary ethical standards. The last person who should have been collaborating with the industry over policy proposals is the person in line to run the agency. Yet Califf did exactly that in the August meeting.

That such collusion between the FDA and industry is “standard procedure” for the agency is alarming. This collaboration must cease immediately, and an independent investigation is needed to uncover how such collusion occurred in the first place.

Finally, in response to this outrageous news, the U.S. Senate should, at minimum, halt consideration of Califf’s nomination until it has an opportunity to investigate this matter fully. Califf’s participation in this collusion with industry provides still further evidence that his nomination should be rejected. The attitudes he has developed over his decadeslong history of extensive financial ties to pharmaceutical and medical device companies leave him all too willing to promote the interests of regulated industries over those of public health and patient safety. These entrenched attitudes do not befit the position of FDA commissioner.