Rep. Hinchey Introduces the FDA Improvement Act of 2010; the Bill Would Unravel User Fee Legislation, Among Other Changes

By Kurt R. Karst –      

Just one day after FDA Commissioner, Dr. Margaret Hamburg, testified last week before the U.S. Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies on FDA’s Fiscal Year 2011 budget request, which includes new user fees, Representative Maurice Hinchey (D-NY) announced the introduction of H.R. 4816, the FDA Improvement Act of 2010 (“FDAIA”).  FDAIA is a sweeping reform bill that would unravel the Prescription Drug User Fee Act and other similar legislation establishing user fee systems for medical devices and animal drugs.

Alleging that FDA “as an institution remains too closely tied to the pharmaceutical industry,” the bill would amend the FDC Act to add § 743 to prohibit FDA from collecting user fees paid by companies, and instead require that those funds be deposited into the general fund of the U.S. Treasury.  And “to ensure there is no reduction in FDA services as a result of the loss of those fees, [FDAIA] provides mandatory funding levels that would be appropriated by Congress to ensure no services are lost.” 

FDAIA would also terminate any existing and future user fee agreements concerning FDA review and action goals on drugs, devices, animal drugs, or generic animal drugs.  Under proposed FDC Act § 744:

On and after the date of the enactment of [FDAIA] . . .  The Secretary may not enter into agreements with such persons on particular uses of the fees, including agreements on priorities, performance goals, or other commitments . . . . Any such agreement or understanding that was in effect on the day before the date of [FDAIA] is terminated . . . .  The Secretary is relieved of responsibility for meeting any particular goals concerning such review times that were established in such letters.

Instead:

The Secretary of Health and Human Services . . . shall submit to the Committees on Appropriations and Energy and Commerce of the House of Representatives and the Committees on Appropriations and Health, Education, Labor, and Pensions of the Senate a comprehensive review of the drug and device application and amendment process to identify ways to increase efficiency, reduce paperwork, speed analysis, and promote the quickest possible decision process designed to ensure the entry of safe, effective drugs and devices into the marketplace.

In addition to significantly changing the long-established user fee systems, FDAIA would:

• Establish an independent Center for Postmarket Drug, Device and Biologic Safety and Effectiveness as a separate center at the organizational level immediately below the Office of the Commissioner.  The new center would monitor all approved drugs and create standards for drug advertisements (FDAIA § 3); 

• Require all direct-to-consumer advertisements to include a toll-free phone number to allow consumers to report negative side effects of prescription drugs to the FDA, and impose new user fees on drug and device advertisements (FDAIA § 4 & § 9); 

• Amend FDC Act § 521 to add a new subsection, titled “No Effect on Liability Under State Law,” which states: “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”  The provision would apply to any civil action pending or filed on or after the date of the enactment of FDAIA, and would be retroactive to the enactment of the Medical Device Amendments of 1976, which added FDC Act § 521 (FDAIA § 5);

• Enable FDA to mandate changes to labels of FDA-approved products if a new risk is discovered, require Secretary of Health and Human Services to review and revise FDA’s drug labeling regulations “to improve the clarity and readability of such labeling,” and require FDA to make available information on all clinical trial adverse events (FDAIA § 6 & § 7);

• Require that all FDA advisory 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 § 8); and

• Amend the FDC Act to add § 1101 requiring FDA to promulgate regulations requiring that, before prescribing a drug “the physician inform the patient that the use for which the physician intends to prescribe the drug has not been approved by the Food and Drug Administration” and “the physician obtain from the patient an acknowledgment of such fact and the consent of the patient to use the drug for such use notwithstanding such fact.require doctors to inform their patients when they are prescribing a drug for an unapproved use” (FDAIA § 10).

Although Rep. Hinchey is reportedly working to “actively garner support among his colleagues in the House” for FDAIA, there are currently no co-sponsors listed for the bill on THOMAS.  It has little likelihood of passage.