FDA, AdvaMed collaboration on 21st Century Cures raises eyebrows

When the FDA wanted some help hashing out device regulation for the 21st Century Cures Act earlier this year, it relied heavily on an unlikely ally: the medical device industry.

Regulators teaming up with lobbyists to write legislation is nothing new, Bloomberg points out. But the FDA's recent work with AdvaMed on the bill is raising eyebrows from some industry watchers and consumer groups, who say that the level of collaboration exceeds normal boundaries.

"They characterized this as being standard practice. If this type of collusion is standard practice, that's alarming," Michael Carome, an opponent of the bill and director of Public Citizen's health research group, told the news outlet. "The FDA appears to be bending over backwards to please the industry and to address their interests above others."

The FDA's Center for Devices and Radiological Health (CDRG) and AdvaMed "worked together on the proposed language for most of the device provisions in" the Cures Act, according to an FDA memo seen by Bloomberg from an Aug. 7 meeting after the bill passed with bipartisan support. Robert Califf, who was recently nominated to lead the FDA, also attended the meeting, along with AdvaMed officials and execs from device giants Johnson & Johnson ($JNJ) and St. Jude Medical ($STJ).

The teamwork is questionable given the implications of the Cures bill. The legislation increases funding for the FDA and the National Institutes of Health, but it also makes it easier for companies to get new devices to market. Devicemakers can submit a wider range of information to the FDA for product approval, including published journal articles or case studies, instead of data from an original trial submitted directly to the agency, Bloomberg points out. The bill also gives device manufacturers the option of paying a third-party company to evaluate a device's safety, rather than relying on the FDA to certify any changes in design.

Still, the industry and the FDA are standing by their collaboration. Creating the Cures bill was a "very open an inclusive process collecting input across the health care community via written statements, town hall meetings, roundtables and hearings," said AdvaMed spokeswoman Wanda Woebius, as quoted by Bloomberg.

And regulators working with industry groups when crafting legislation is standard procedure, FDA spokeswoman Jennifer Dooren told the news outlet. "FDA officials routinely meet with a diverse group of stakeholders including industry, patient groups and consumer groups" and Congress "regularly asks" the agency for help on modifying language proposed by outside groups, "as was the case here," Dooren said.

But AdvaMed and the FDA are keeping quiet on how many times the groups met, and the agency isn't answering questions about whether any other groups worked with the FDA on the text of the proposed bill. J&J and St. Jude did not respond to Bloomberg's requests for comment.

- read the Bloomberg story