Measures in the U.S. Congress that would link research funding to moves designed to simplify the approval process for medical devices and drugs is reportedly drawing flak from public health advocates, including a former FDA commissioner.
Last July, the U.S. House of Representatives passed the 21st Century Cures Act, a sweeping bill to speed new medical devices and drugs to the market containing some $9.3 billion in funding over 5 years for the FDA and the National Institutes of Health. Consumer advocates and FDA watchers soon cried foul, after FDA documents showed what some saw as an unprecedented level of collaboration between the agency and an industry it regulates. 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.
In the Senate, Health, Education, Labor & Pensions committee chairman Sen. Lamar Alexander (R-Tenn.) is looking to get a package of bills to the Upper Chamber floor, plus an NIH funding bill; Alexander told the Journal the package is “the most important bill Congress considers this year.”
Dr. David Kessler, who was commissioner of the federal safety watchdog from 1990 t0 1997 under Presidents George H.W. Bush and Bill Clinton, told the Wall Street Journal that tying the funding to FDA approvals is “a deal with the devil.”
“This is the 1st time this has been done this way, and it’s a deal with the devil,” Kessler told the newspaper. “It’s time to uncouple the promise of research funding from the requirement that FDA standards be lowered.”
“Medical schools depend heavily on NIH funds,” added Daniel Carpenter, a Harvard government professor and FDA expert. “So if you want these research funds, you’ll have to take the other pill [on FDA standards].”
Rep. Fred Upton (R-Mich.), the leading proponent of the House bill, said critics had their chance to oppose it. “We worked with the administration,” he said. “In no way are we shortchanging safety of drugs and devices.”
“Dumbing down FDA approval standards is the biggest concern with these pieces of legislation,” countered Jerry Avorn, a Harvard medical professor. “The idea that Congress should decide details of drug regulation is a weird one.”
“This legislation, if not carefully crafted, could pose significant risks for FDA and American patients,” new FDA commissioner Dr. Robert Califf said in a recent speech. “Innovative therapies are not helpful to patients if they don’t work, or worse, cause harm.”
The 21st Century Cure Act includes provisions allowing approval for some medical devices based on anecdotal evidence or medical journal articles, not controlled clinical studies. It would also ease the Sunshine Act transparency law and stop requiring advanced trials for some antibiotics.
Senate Democrats have pushed back against some of those measures, “people familiar with the talks” told the paper, but if the Senate version does pass, reconciling the 2 chambers’s bills could mean that the House provisions make it to the final bill – which could also be amended from the Senate floor.