September 21, 2005
Senate Backs Watered Down Version of FDA Bill
The Senate late Tuesday passed an amendment that will create greater transparency when the Food and Drug Administration puts scientists with drug industry ties on its advisory panels. While this measure doesn't go as far as the bill the House passed last June, which would ban the practice, it is a step in the right direction.
The legislation, sponsored by Sen. Richard Durbin of Illinois, requires that the FDA post the names of scientific advisers granted waivers for their conflicts of interest on their website at least 15 days before an advisory committee meeting. It also requires that the FDA simultaneously publish the nature of those conflicts on its website.
Currently, the public has to file a freedom of information request to get the names of the companies involved and the amounts paid to those scientists for consulting, speaking, doing studies and the like. Anyone who has ever filed a FOIA request with FDA (or most other agencies in this administration) knows that the process can take years.
There is one final element to the Senate bill. The FDA will have to document its efforts to find unconflicted scientists every time they create a new advisory panel. While this in itself doesn't change anything, it creates an incentive for the agency to at least try to find unconflicted scientists since the alternative is to file blank reports.
Removing the ban on conflicted scientists that was contained in Rep. Maurice Hinchey's amendment, which passed the House 218-210 last June, rendered the Senate version "virtually noncontroversial," according to Sen. Robert Bennett (R-Ut), chairman of the Appropriations Committee. "It is important that we do not enforce the conflict-of interest issue with such difficulty that ultimately the pharmaceutical companies are cut off from any opportunity of ever consulting with the best experts in the field because those experts want to also remain available to the FDA," he said.
Let's follow Bennett's logic for a moment. He fears leading physicians across the country will drop those $10,000 and $20,000-per-year consulting gigs in order to serve on FDA advisory committees, where they get plane fare, a hotel room and lunch in exchange for several days wrestling with an FDA briefing book and sitting through a daylong meeting.
Put that together with the FDA's claim that "everyone who is anyone consults for industry" and you have the most persuasive case yet for why the conference committee should pass the Hinchey version of the bill. It will get at least a few leading physicians off industry's payrolls and onto the public's side!