The FDA and the medical device industry reportedly collaborated on drafting the 21st Century Cures Act before its passage in the U.S. House last summer, drawing criticism from consumer watchdogs and FDA experts.
The 21st Century Cures Act, as approved on a 344-77 House vote in July, would speed new medical devices and drugs to the market by requiring the FDA to streamline its approval process, consider more flexible forms of clinical trials and incorporate patient experience into its decision-making process.
The program would be paid for with the sale of 80 million barrels of crude oil from the Strategic Petroleum Reserve over 8 years. The bill was developed by the House Energy & Commerce Committee and spearheaded by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.). A similar bill in the Senate is expected to be voted on before the end of the year.
Recently released FDA documents show what some experts see as an unprecedented level of collaboration between the federal safety watchdog and an industry it regulates, according to BloombergBusiness.
The FDA and a medtech industry lobby, AdvaMed, held regular, private meetings to write the bill even as Congress held public roundtables about the bill, according to documents released via a public records request, the news service reported.
“They characterized this as being standard practice. If this type of collusion is standard practice, that’s alarming,” Michael Carome, director of Public Citizen’s health research group, told the service. “The FDA appears to be bending over backwards to please the industry and to address their interests above others.”
“FDA drafting legislation in consultation with outside entities, whoever they are, strikes me as unusual,” added Susan Wood, a former assistant commissioner of women’s health at the agency. “It gives a great deal more weight to the industry representatives on very specific legislation that affects both FDA and the industry, and others were not at that table.”
“The 21st Century Cures legislation came from industry in the first place,” said Mary Pendergast, a former FDA deputy commissioner. “This is part and parcel of the bigger way in which Congress runs its shop.”
The FDA’s Center for Devices & Radiological Health and AdvaMed “worked together on the proposed language for most of the device provisions in” the Cures Act, according to an FDA memo from an Aug. 7 meeting attended by Dr. Robert Califf, the cardiologist nominated by who President Barack Obama to be the FDA’s new commissioner. Executives from Johnson & Johnson (NYSE:JNJ) and St. Jude Medical (NYSE:STJ) also attended, BloombergBusiness reported.
“For the Senate version of 21st Century Cures, CDRH is currently working with AdvaMed to refine their regulatory strategy in a way that is agreeable to both parties,” according to the August meeting memo.
AdvaMed spokeswoman Wanda Moebius told the news service that the creation of the 21st Century Cures bill was a “very open and inclusive process collecting input across the health care community via written statements, town hall meetings, roundtables and hearings.”
AdvaMed denied that the bill would weaken the “FDA’s robust standards” and said Congress was ultimately responsible for the content of the legislation.
FDA spokeswoman Jennifer Dooren told the service that the collaboration was standard procedure.
“FDA officials routinely meet with a diverse group of stakeholders including industry, patient groups and consumer groups,” Dooren wrote in an e-mail. “Congress regularly asks us for technical assistance about how to modify language proposed by outside groups, as was the case here.”