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Appropriations Report Outlines Separate FDA Post-Market Drug Safety Office

This article was originally published in The Tan Sheet

Executive Summary

Report language for a pending House appropriations bill for FDA outlines the need for an independent office within the agency to evaluate a drug's safety after it is marketed

Report language for a pending House appropriations bill for FDA outlines the need for an independent office within the agency to evaluate a drug's safety after it is marketed.

Such an office would avoid the potential for bias that arises when FDA staff who approve a drug are the same people who make decisions when a marketed drug's safety is called into question, according to Rep. Rosa DeLauro, D-Conn., who chairs the Appropriations subcommittee with oversight for the Department of Agriculture, FDA and rural development agencies and programs.

The subcommittee reported its fiscal 2011 appropriations measure June 30, though details will not be available until after the full committee markup.

DeLauro did not provide specific language on a separate safety office during the subcommittee markup, but noted she developed it with assistance from Sen. Charles Grassley, R-Iowa, and Rep. Maurice Hinchey, D-N.Y.

Hinchey introduced the FDA Improvement Act of 2010, H.R. 4816, which would establish within the agency an independent Center for Post-Market Drug, Device and Biologics Safety and Effectiveness (1 (Also see "Congress Emphasizes Strings As FDA Asks For Greater Budget Purse" - Pink Sheet, 15 Mar, 2010.)).

Report language does not have the force of law. Rather, it accompanies a piece of legislation reported by a committee and is used to indicate how members intend a statute to be interpreted and implemented.

Since the Appropriations panel cannot write authorizing legislation, the language in the funding bill report would be an indicator of committee members' interest in the topic.

The report language on a safety center will not be official until approved by the full Appropriations Committee. No date is set as yet for a panel meeting on the USDA/FDA spending bill.

Congress' failure to adopt a fiscal 2011 budget has slowed the appropriations process, leading to speculation that an omnibus multi-department spending bill may be necessary.

Full committee Chairman David Obey, D-Wis., however, assured subcommittee members he expects to bring the USDA/FDA appropriations measure to the full panel as a separate entity.

The subcommittee bill would provide FDA with $2.57 billion in direct funding and $1.2 billion from user fees, for a total of $3.77 billion in fiscal 2011. The direct funding total is $55 million more than the amount President Obama's budget proposal requested for FDA.

For the current fiscal year ending Sept. 30, Congress appropriated $2.36 billion in direct funds, $306 million more than in 2009, with an additional $893 million from user fees for FDA.

DeLauro noted the 2011 measure would provide $2 million for the Division of Drug Marketing and Communication to review drug companies' communications to medical professions; $15 million more for the Office of Generic Drugs than was requested; and a $3 million increase in DDMAC funding to review direct-to-consumer ads.

The DTC review funds should remind the pharmaceutical industry of DeLauro's power to shape FDA policy. During the last user fee reauthorization, the agency and pharma companies negotiated a user fee program for advertising review, but DeLauro blocked FDA from spending funds to implement it.

The appropriations report also asks FDA to report on the status of standards for a track and trace system to document all parties involved in the sale, purchase and trade of a given prescription drug, beginning with the manufacturer.

The White House's fiscal 2011 budget request included $18 million for dietary supplement programs within the Center for Food Safety and Applied Nutrition, plus related enforcement activities within the Office of Regulatory Affairs, up slightly from the $17.4 million appropriation for 2010. For OTC drug programs within the Center for Drug Evaluation and Research, the administration proposed a $17.1 million budget, down slightly from $17.2 million (2 (Also see "FDA Budget In Brief" - Pink Sheet, 8 Feb, 2010.)).

- Cathy Dombrowski ( 3 [email protected] )

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