Unseemly and Inappropriate: FDA Joined With the Medical Device Industry in Drafting Cures Legislation

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

Note: Today, Inside Health Policy reported that senior officials at the U.S. Food and Drug Administration collaborated with representatives from the medical device industry on the wording of the 21st Century Cures bill, passed by the U.S. House of Representatives in July. What’s more, the FDA and industry are strategizing together about how to get a companion bill through the Senate. The bill would weaken oversight of medical devices and is opposed by Public Citizen and other consumer and patient advocacy groups. Dr. Robert Califf, nominee to head the FDA, participated in at least one high-level strategy meeting with the industry regarding these efforts.

It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association 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 result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices.

No one from the FDA should ever 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 Dr. Robert Califf, the current nominee to serve as FDA commissioner, did exactly that.

In response to this outrageous news, the U.S. Senate should, at minimum, halt consideration of Dr. Califf’s nomination until it has an opportunity to investigate fully exactly what occurred. We believe that news of Dr. 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 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. This is not compatible with being the FDA commissioner.