Some public health experts are crying foul over moves in Congress to link billions of dollars in medical research funding to proposed FDA standards that would make it easier for medical device and drug companies to gain regulatory approvals at the expense of patient safety.
The link between funding health research and easing FDA standards was first made almost a year ago when the U.S. House of Representatives passed the 21st Century Cures Act, which provided $8.75 billion for the National Institutes for Health and an additional $550 million for the FDA, The Wall Street Journal reported.
In exchange for the funding, the House bill would eliminate rules requiring doctors to disclose hefty payments they receive from medical device makers for using their products; the need for some advanced trials of antibiotics; and that some medical devices could be marketed on the basis of only anecdotal evidence or medical journal articles instead of controlled medical studies.
"This is the first time this has been done this way, and it's a deal with the devil," Dr. David Kessler, a former FDA commissioner, told the WSJ. "It's time to uncouple the promise of research funding from the requirement that FDA standards be lowered."
Similar legislation has been proposed in the Senate under the argument that such changes to regulatory approvals of devices and drugs would result in more innovative and life-saving products and research.
"Dumbing down FDA approval standards is the biggest concern with these pieces of legislation," Jerry Avorn, a medical professor at Harvard University, told the newspaper. "The idea that Congress should decide details of drug regulation is a weird one."
Recently, the new FDA commissioner, Dr. Robert Califf, said that if not carefully thought out the new legislation "could pose significant risks for FDA and American patients."
The National Center for Health Research and Public Citizen--both patient-advocacy groups--have also voiced concern about the proposed legislation, saying the bills in Congress could jeopardize safety.
However, Representative Fred Upton, a Republican and supporter of the House bill, said critics had their opportunity to oppose the legislation. "We worked with the (Obama) administration (and) in no way are we shortchanging safety of drugs and devices."
- check out the WSJ article (sub. req.)