The financial relationships between the U.S. Food & Drug Administration (FDA) and the industries it regulates have led to enormous controversy in the past, one result of which was the implementation of strict conflict-of-interest rules for members of agency panels charged with approving new drugs. Recently however, concerns have emerged that the existing FDA conflict-of -interest rules have made it too difficult to find enough qualified experts to serve on these panels. According to a Reuters report, those concerns are likely to result in a weakening of those safeguards in the very near future.
Congressional lawmakers are expected to mandate that the FDA ease up on the restrictions that prevent advisors from reviewing a medicine if any financial ties link back to the manufacturer, Reuters is reporting. The new directive will take the form of an amendment added to an FDA funding bill. Of note, drug and device maker fees account for over one-third of the FDAâ€™s funding.
The issue was raised by senators at last weekâ€™s Health, Education, Labor, and Pensions Committee. “Based on today’s hearing and the comments from Senators Franken and Enzi, I think there is a good chance that this issue could end up in the final FDA user fee bill,” said a congressional staff member referring to Mike Enzi, the top ranking Republican on the committee and Democratic committee member Al Franken, reported Reuters.
The FDA is often forced to put off panel meetings while conflict-free experts are secured, said the lawmakers and FDA officials, wrote Reuters. The best doctors, however, are typically hired by pharmaceutical companies as speakers or consultants. The result has been a 23 percent vacancy level on FDA panels, which is over twice the agencyâ€™s goal, said Reuters, citing the FDAâ€™s quarterly report, which was last issued in May.
“We have had difficulty in recruiting highly qualified people. And we’ve had delays in having panels because of this,” said Dr. Janet Woodcock, head of the FDA’s drug center, said Reuters. Dr. Woodcock was speaking at a House of Representatives hearing.
In 2007, the FDA strengthened its guidelines in an effort to mitigate industry ties that could affect panelist views of medications, in part following a Vioxx scandal in which 10 of 32 FDA panelists consulted for industry and 9 of 10 put Merckâ€™s Vioxx back on the market after it was pulled in 2004 over cardiac risks, wrote Reuters.
But lawmakers say the restrictions are too stringent and seek to speed the approval of more new drugs because it will help commerce and improve Americaâ€™s troubled economy.
Some feel that the rules are overkill and physicians linked to studies should be excluded, but not experts with other industry ties; for instance, physicians tied to facilities that are tied to industry.
Others feel that the agency could look deeper to avoid such conflicts. “There are lots of people out there who are smart and who don’t have conflicts of interest,” said Sid Wolfe of the consumer advocacy group Public Citizen, reported Reuters. “It just takes much more work for the FDA to find them. But the result is you have much less tainting of the panel discussion,â€ he added.