The U.S. Food and Drug Administration worked with a medical device lobbying group when creating legislation on relevant tools, such as the 21st Century Cures bill, according to an investigative report from InsideHealthPolicy.
The report notes that FDA Acting Commissioner Stephen Ostroff, and other agency officials, met with representatives from the Advanced Medical Technology Association (AdvaMed) to discuss the Cures legislation. The information culled for the report comes from emails and documents InsideHealthPolicy obtained through a Freedom of Information Act request.
In addition, non-government sources said they were "alarmed" at the relationship between the lobby group and the FDA, as well as the influence the former had on the Cures bill, which passed the House and is being scrutinized by the Senate.
The FDA said the meetings with AdvaMed were standard procedure; an FDA spokesperson said it is routine for agency officials to "meet with a diverse group of stakeholders."
However, the report also noted that documents show the two groups worked on med device provisions in the Cures act together, including review for devices, quality assessment and more. After the revised version of the draft was released in April, AdvaMed released a statement praising the provisions included in the bill, the report added.
Some doctors voiced concerns about the bill's take on medical devices earlier this fall. Susan Molchan, M.D., James Rickert, M.D., and John Powers, D.M.D, wrote at Health Affairs that the fervor around the bill "obscures measures buried within that many agree will make newly approved drugs and medical devices less safe and effective, increase the cost of medical products, and discourage innovation in biomedical research."
Privacy advocates also came out against the legislation.
To learn more:
- here's the report