FDA and the largest medical device lobbying group worked together to develop proposed legislative language for most of the medical device provisions included in the House-passed 21st Century Cures bill, one of the largest FDA reform bills to pass the House in recent years, and are developing a synchronized regulatory strategy for the Senate version, according to internal emails and documents obtained by Inside Health Policy through the Freedom of Information Act.


President Barack Obama’s nominee for FDA commissioner, who has come under fire for his past relationships with industry, was aware of the partnership between the agency and the device lobbying group on legislative proposals, according to the emails and documents, and attended meetings with the group along with FDA's acting commissioner and the device center director.


The agency defended the meetings with the device lobbying group as standard procedure and said that Congress requested technical assistance from FDA on the Cures legislation. And, while congressional sources claimed the practice of soliciting outside opinion on legislation was critical to the legislative process, sources off Capitol Hill said they were alarmed at the level of coordination between the agency and the device lobbying group and the amount of influence both parties had over the Cures legislation.


On Aug. 7, FDA officials, including Acting Commissioner Stephen Ostroff, Deputy Commissioner and Commissioner-nominee Robert Califf and Center for Devices and Radiological Health chief Jeff Shuren met with representatives from the Advanced Medical Technology Association (AdvaMed), including Steve Ubl, who then headed the association and is now president of the pharmaceutical drug lobby group, and Janet Trunzo, AdvaMed senior executive vice president of technology and regulatory affairs, as well as individuals from Johnson & Johnson, CVRx Inc. and St. Jude Medical Center.


A background document shared in advance of the meeting with a number of FDA officials, including Califf and Shuren, as well as Larry Morris, executive assistant to Ostroff, Sally Howard, senior advisor and acting chief of staff to Ostroff and Franklin Joseph, associate chief counsel for the agency, notes that FDA and AdvaMed met regularly during the legislative process and that the agency and the device lobbying arm had jointly written legislative text for Energy & Commerce Chairman Fred Upton’s (MI) signature piece of legislation.