The Agriculture Appropriations conference report approved by the House and Senate doubles the Administration's requested increase in drug safety funding for FDA to $10 mil.

"The conferees intend that these increases be used for FDA's highest priority drug safety needs that were not funded in fiscal year 2005," the fiscal 2006 Agriculture Appropriations ¹ conference report states.

The Senate passed the measure 81 to 18 on Nov. 3. The House agreed to the report on Oct. 28 by a vote of 318 to 63. The legislation now goes to President Bush to be signed into law.

The "unmet needs" from FY 2005 include the "hiring of additional scientists or the acquisition of databases to which FDA does not now have access to help track adverse drug events," the report states.

"The conferees direct FDA to provide a report to the Committees on Appropriations within 30 days of enactment, setting forth its proposed use of these funds in detail, including an object class breakout for the $10 mil. increase," the conference report states.

The Center for Drug Evaluation & Research is raising the profile of its drug safety activities through a series of organizational changes.

The conference agreement also increases funds for direct-to-consumer advertising monitoring by $884,000.

Although the conference report does not specify the reason for the additional funds, the ² House report states that "because staff levels for these activities, under the Division of Drug Marketing, Advertising and Communications...have remained flat for some time, despite the growth of [DTC] ads, the Committee believes this increase is needed."

During floor debate on the Agriculture Appropriations bill, Sen. Patty Murray (D-Wash.) withdrew four amendments related to Barr's over-the-counter switch application for Plan B in exchange for a promise that the conference report would express Congress' concern with FDA's approval process for the product.

"The conferees remain concerned about the legal and regulatory issues relating to approval of drugs as both prescription and over-the-counter products, and urge FDA to expedite rulemaking on this topic," the report states.

The conference report adopts a Senate provision that limits FDA's ability to grant conflict of interest waivers for advisory committee members. A quarterly report to the HHS Inspector General and both Appropriations Committees will be required on the efforts made to identify committee candidates with minimal or no potential conflicts of interest. The conferees eschewed the more restrictive House version.

The conference report dropped a provision included in the Senate report that "strongly" encouraged FDA to work to ensure that "authorized" generics do not have a detrimental competitive effect (³ Also see "FDA Report On Citizen Petition Impact On ANDAs Sought By Senate Panel" - Pink Sheet, 27 June, 2005., p. 14).

In May, Sens. Charles Grassley (R-Iowa), Patrick Leahy (D-Vt.) and John Rockefeller (D-W.Va.) sent a letter to the Federal Trade Commission requesting a study on the competitive impact of authorized generics (⁴ Also see "FTC Should Study Competitive Impact Of “Authorized” Generics, Senators Say" - Pink Sheet, 16 May, 2005., p. 3).

The FTC said that it does not have plans to conduct such a study, although Grassley's office said the commission had made a verbal promise to do so.

However, budget reconciliation legislation from both chambers could make such a study moot: provisions included in the legislation that would include authorized generics in the calculation of "best price" could effectively end the practice.

The appropriations conference report removes language from the ⁵ Senate report which had directed the FDA to report to Congress on its efforts to improve the citizen petition process, with particular regard to generic drug applications. The conferees also elected to exclude sections relating to anticounterfeiting technologies and follow-on biologics.

The report follows the House's recommendation by providing $520 mil. for CDER (the Senate proposed $515 mil.), while the $178 mil. in funding for the Center for Biologics Evaluation & Research matched that proposed by both the House and Senate.

Drug Safety Funding To Increase By $10 Mil. Under FDA Appropriations

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