House Committee Adds $5.9 Mil. To FDA Budget For Drug Safety, Ad Review
This article was originally published in The Pink Sheet Daily
Executive Summary
The Appropriations Committee unanimously endorses a managers’ amendment that would provide FDA with an additional $5 mil. for “highest priority drug safety needs” and $884,000 for ad review division staff in fiscal year 2006.
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The House Appropriations Committee added almost $5.9 mil. to FDA's fiscal year 2006 budget during a mark up of the Agriculture Appropriations bill May 25. The committee unanimously approved a managers' amendment that would allot FDA an additional $5 mil. in funding for "the highest priority drug safety needs." A "detailed spending plan" for the drug safety funds would be required within 30 days of the bill's enactment. The bill also would increase funding for FDA's review of direct-to-consumer advertisements for drugs by $884,000, doubling the current level. "Because staff levels for these activities...have remained flat for some time, despite the growth of direct-to-consumer ads, the committee believes this increase is needed," the managers' amendment said. Under the bill, FDA's 2006 budget would total $1.48 bil., which represents a $36 mil. increase over the FY 2005 level but falls $14 mil. short of President Bush's budget request. The bill includes an amendment, attached by the Agriculture Subcommittee, that would withhold 5% of funds from FDA's central offices until the head of the agency testifies before the subcommittee on the President's budget request (1 (Also see "FDA Commissioner Confirmation Under Further Pressure From House Subcommittee" - Pink Sheet, 17 May, 2005.)). The Appropriations Committee voted 31-25 to reject an amendment offered by Rep. Maurice Hinchey (D-N.Y.) that would empower FDA to require post-marketing studies and mandate label changes for drugs. The committee also rejected an amendment offered by Rep. Jack Kingston (R-Ga.) that would prohibit FDA from specifically targeting for enforcement purposes pre-1962 "DESI" drugs solely because they lack pre-market approval. The appropriations bill will be introduced on the House floor following a one-week Memorial Day recess. The Senate Appropriations/Agriculture Subcommittee has not yet marked up a bill. - Brian Marson |