US Device Industry and FDA “Colluded” on Legislation to Weaken Regulatory Oversight

Jeanne Lenzer, THE BMJ: December 17, 2015

US Food and Drug Administration officials had multiple meetings with leaders of the medical device industry to craft legislation that critics say will severely weaken regulatory oversight of the industry, an investigation by the online news service Inside Health Policy has found.

The revelations, discovered in emails and documents obtained under the Freedom of Information Act, have led to renewed calls by professional and public interest watchdog groups to defeat companion legislation to the proposed 21st Century Cures Act, which has been referred to the Senate. They have also called to oppose the approval of Robert Califf as a nominee for the role of FDA commissioner because he took part in meetings with the Advanced Medical Technology Association (AdvaMed), a trade association for medical technology companies.


Michael Carome, director of the health research group at Public Citizen, a public interest organization, described as “unseemly and inappropriate” the meetings between the FDA and the device industry to craft the language in the act.

Carome said that Califf’s “participation in this collusion with industry” should, at a minimum, put Califf’s nomination as FDA commissioner on hold pending an investigation. Carome said, “The attitudes [Califf] has developed over his decades long 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.”

The National Physicians Alliance, together with Public Citizen and six other organizations, wrote a letter to the House of Representatives on 19 May, stating that the 21st Century Cures Act “fails to ensure a . . . scientifically based approach” to drug and device approval and that it will allow “unsafe and ineffective drugs and medical devices to enter the market.”


The FDA defended its meetings with the industry, telling The BMJ that “FDA officials routinely meet with a diverse group of stakeholders.” The agency said that it had met with 12 representatives of public interest and professional organizations who attended a meeting on 28 October, after the bill was referred to the Senate in July.

Diana Zuckerman, president of the National Center for Health Research, whose organization requested the October meeting, told The BMJ that none of the more than two dozen non-profit organizations that are members of the Patient, Consumer, and Public Health Coalition had been invited by the FDA to help develop any provisions of the 21st Century Cures Act or its Senate companion bill.

She said, “There’s a world of difference between talking about approval standards in general and crafting specific legislative language. It is outrageous that FDA officials and regulated industry are sitting down to craft legislative language to give to congressional staff.”


BMJ 2015; 351 Cite this as: BMJ 2015;351:h6820

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