Congress Emphasizes Strings As FDA Asks For Greater Budget Purse

FDA Commissioner Margaret Hamburg's testimony before congressional appropriations subcommittees inspired a sense of déjà vu even though she was testifying on the agency's budget for the first time since assuming the post nearly 10 months ago.

Members of both parties extolled FDA's work during a March 10 Senate hearing and a House hearing the next day, but also pressed for changes. The House hearing particularly underscored that the agency is not going to get a respite from congressional pressure even if the White House and the majority in Congress are in the same party.

House Appropriations Committee members are preparing legislation to give the agency further authority to curb direct-to-consumer advertising and to place more stringent restrictions on FDA's relationship with the pharmaceutical industry.

Rep. Jo Ann Emerson, R-Mo., said she is working with Chairwoman Rosa DeLauro, D-Conn., on a proposal to ban newly approved drugs from participating in DTC advertising for the first three years of marketing. Both congresswomen also expressed unease with DTC advertising's slippery slope into social networking and new media forms of communication (¹ (Also see "FDA Officials Promise More "Swift, Aggressive" Actions, Outline Priorities" - Pink Sheet, 19 Oct, 2009.)).

During the Agriculture Subcommittee's hearing on FDA's fiscal 2011 budget, Rep. Maurice Hinchey, D-N.Y., expressed misgivings about what seems to be the agency's continually growing "comfy relationship" with industry.

The Obama administration proposes an overall FDA budget of $4.03 billion for fiscal 2011, a 22.8 percent increase over the 2010 appropriation. The total includes appropriated funding of $2.51 billion, a 6.2 percent increase, with the remainder from fees.

In the proposal, FDA seeks $1.04 billion for food programs, a 32.9 percent increase that includes $182.8 million in broadly applied food registration and inspection fees and $6.5 million in more targeted re-inspection fees (² (Also see "FDA Budget Request Shows Optimism For Broad Food Safety User Fees" - Pink Sheet, 8 Feb, 2010.)).

"Most importantly, the fiscal 2011 resources allow FDA to establish a foundation for an integrated national food safety system focused on prevention," Hamburg told the House subcommittee.

Litany Of Fixes

Hinchey later introduced the Food and Drug Administration Improvement Act of 2010, H.R. 4816, which aims to sever the financial link between industry and FDA created by user fees, revamp the agency's post-market drug safety operations, impose fees on drug company advertising and eliminate conflicts-of-interest in FDA advisory committees.

None of the concepts are new, and some would simply further tighten restrictions imposed on FDA in the 2007 round of user fee reauthorization.

Hinchey's bill would prohibit FDA from collecting fees paid by companies it regulates and would require depositing those funds into the general fund of the Treasury. To ensure there is no reduction in FDA services as a result of the loss of those fees, Hinchey's measure provides mandatory funding levels that would be appropriated by Congress.

"The FDA would be fully funded by and accountable to the U.S. taxpayers, instead of drug manufacturers," he said in a release.

H.R. 4816 also would establish an independent Center for Post-Market Drug, Device and Biologic Safety & Effectiveness to monitor approved drugs and create standards for drug advertisements. The center would be located within the FDA and staffed by "professional scientific analysts" who would be independent of the initial approval process.

In an effort to "better ensure truth in advertising" by drug and device manufacturers, FDAIA would impose new fees on drug and device advertisements in order to raise funding for the agency to help oversee and regulate those advertisements. Hinchey also proposes that DTC ads include toll-free phone numbers for reporting negative side affects of prescription drugs to FDA.

To address conflict-of-interest issues at advisory committee meetings, the bill would require that all the panels be composed of qualified experts who do not have any financial ties to companies who have a stake in the topic under discussion.

FDAIA would address concerns about the practice of doctors prescribing drugs for off-label use by requiring doctors to inform their patients when they are prescribing a drug for an unapproved use.

Hinchey said the Consumers Union backs the bill and he will seek support from colleagues in Congress.

- Lauren Smith ( ³ [email protected] )