The Senate Appropriations Committee requests FDA report within 45 days on improvements to the citizen petition process as it relates to generic drug applications.

"The committee directs FDA to provide a written report within 45 days of enactment, explaining its citizen petition process improvement efforts, particularly as they relate to the ANDA approval process," the FY 2006 Agriculture Appropriations report states.

The committee requests that the agency create "a timeline for implementation of any reforms deemed necessary."

The appropriations bill was marked up by the committee June 23; a vote by the full Senate is unlikely to occur before the chamber's July 4 recess.

FDA has been re-examining its citizen petition review process with the aim of expediting decisions on ANDAs (¹ Also see "FDA Re-Examining Citizen Petition Process To Speed Generic Approvals" - Pink Sheet, 7 March, 2005., p. 34).

The generic industry has complained that brand companies can obtain a de facto patent extension on a product by filing an eleventh-hour citizen petition just ahead of generic approval.

The committee report also urges FDA to address the issue of "authorized" generics due to concerns that such products ultimately may have a detrimental effect on generic competition.

"The committee strongly encourages FDA to work to ensure that incentives for generic drugs, which are currently written into law, are protected, and that consumers continue to have access to safe, effective generic drugs at the earliest possible time," the report states.

A bipartisan group of senators, including committee member Patrick Leahy (D-Vt.), has requested the Federal Trade Commission conduct a study on the competitive impact of authorized generics (² Also see "FTC Should Study Competitive Impact Of “Authorized” Generics, Senators Say" - Pink Sheet, 16 May, 2005., p. 3).

The Senate appropriations bill would provide $1.842 bil. in total funding for FDA in fiscal 2006 ($1.485 bil. in non-user fee funding).

The corresponding appropriations measure passed by the House would provide $1.838 bil. ($1.481 bil. non-user fee) to FDA.

The House bill included an amendment that would withhold 5% of the funds from FDA's central offices until Acting Commissioner Lester Crawford testifies before the committee on the Administration's 2006 budget request.

The House and Senate appropriations bills differ slightly in their funding of the Center for Drug Evaluation & Research. The House bill would provide $520 mil. for the drug center, while the Senate bill would appropriate $515 mil. for CDER.

The two bills would fund the Center for Biologics Evaluation & Research at $178 mil.

Both the House and Senate bills also would fully fund the Administration's request for $5 mil. targeted at drug safety activities.

The Senate committee requests FDA issue a report within 90 days of the bill's enactment on the agency's efforts to increase drug safety oversight.

The appropriations panel's focus also extends to follow-on biologics. The committee requests a report on "the feasibility of developing an approval and post-approval monitoring system for follow-on, off-patent biologics."

Along with specifying that $14 mil. be applied to the Orphan Products Grants Program, the committee report requests that FDA improve the clinical trial design and its use of advisory committees when regulating products that treat rare diseases.

"The committee encourages the FDA to make the best possible use of FDA's advisory committee members in FDA's considerations of clinical trial design, and allow the same panel to participate in final review meetings, when feasible," the report states.

The committee also directs FDA to report on its work with companies that use anticounterfeiting technologies and to issue a draft guidance on policies and procedures for use of authentication technologies.

FDA Report On Citizen Petition Impact On ANDAs Sought By Senate Panel

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