FDA Would Lose Direct Access To User Fees Under House Bill

A bill pending in the House Energy & Commerce Committee would place all fees collected from companies regulated by FDA in a general Treasury fund.

The provision would prevent FDA from knowing whether the funds it receives were provided by a company or taxpayers.

The "FDA Improvement Act of 2005" (H.R. 2090) was introduced May 4 by Rep. Maurice Hinchey (D-N.Y.).

FDA's current negotiations with drug companies and its dependence upon funds received from them "significantly compromises the FDA's ability to protect the American people from dangerous products," Hinchey's office said in a release.

In order to ensure that the agency would remain fully funded, the bill requires Treasury to provide mandatory appropriations to allow for review of drug, device and animal drug applications.

In addition to preventing FDA's direct access to the fees, the bill bars the agency from negotiating with drug and device companies on the use of the funds, including agreements on priorities, performance goals and review times for applications.

Furthermore, Hinchey's legislation would terminate any prior agreements that existed. On and after Oct. 1, 2005, "any such agreement or understanding that was in effect on the day before the date of the [bill's passage] is terminated."

The bill contains provisions that would prevent those with financial ties to the industry from serving as advisory committee members.

Under the bill, a tentative list of all proposed advisory committee members would be posted on the FDA website at least 30 days prior to every advisory committee meeting, along with a short biography of each prospective member.

The public would have 20 days to comment on the proposed members of the committee, and a final list of the members would be posted on the agency's website no later than three days before the meeting.

"A member of an advisory committee under this Act may not, with respect to service on such committee, be granted an exemption under section 208(b) of title 18, United States Code (relating to personal financial interests)," the measure stipulates.

The bill has a number of elements that are present in other recently introduced legislation.

For example, the bill would establish a Center for Postmarket Safety & Effectiveness within 180 days of passage.

The center would rank immediately below the Office of the Commissioner and would monitor approved drugs to determine possible postmarket safety and efficacy issues.

HHS would be responsible for appropriating $100 mil. to FDA in 2006 and $125 mil. in 2007 to fund the new center.

Finally, the bill would grant FDA the authority to mandate postmarket studies or label changes to drugs already on the market.

FDA "may require that the manufacturer of an approved drug conduct one or more studies to confirm or refute an empirical or theoretical hypothesis of a significant safety issue" that has been identified through means such as the MedWatch surveillance system or scientific literature, the bill says.

The provision is similar to a requirement of the "FDA Safety Act," introduced by Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Sen. Chris Dodd (D-Conn.) April 27 (¹ (Also see "FDA Safety Center Authority Would Extend To OTCs Under Grassley Bill" - Pink Sheet, 2 May, 2005.), p. 3).

The Center for Science in the Public Interest voiced support for the legislation. "The FDA begins virtually every advisory panel reviewing a new product with a statement waiving the prohibition on conflicts of interest for some of the scientists on the panel," the group said. "Hinchey's bill would prohibit those waivers."

The association has expressed concerns about FDA advisory committee members in the past. A CSPI investigation of the members of the February advisory committee meeting on the safety of COX-2 inhibitors alleged that 10 of the 32 voting members had financial ties to COX-2 manufacturers (² (Also see "FDA Waiver Of COX-2 Panel Conflicts Draws More Attention On The Hill" - Pink Sheet, 7 Mar, 2005.), p. 15).