KOHL URGES PRESIDENT TO REFORM FDA’S DIRECT-TO-CONSUMER DRUG ADVERTISING REVIEW, BOOST BUDGET

WASHINGTON B Today, U.S. Senator Herb Kohl sent a letter urging President Bush to reform the FDAs system for regulating direct-to-consumer (DTC) prescription drug advertisements and augment the agencys budget to manage the increased volume of new ads. Kohls request comes on the heels of an unfavorable Government Accountability Office report examining the impact of DTC advertising of prescription drugs on overall health care spending. In January, Kohl is expected to become the chairman of the Senate Appropriations Committee panel with jurisdiction over the FDA budget.

The report, which was released today, found that the FDA reviews only a very small portion of the DTC materials it receives and cannot ensure that it is identifying the materials it considers to be highest priority.

The FDA does not have formal criteria for prioritization and review of [direct-to-consumer] ads and does not track information on its reviews, Kohl wrote in his letter to the President. Therefore, the FDA cannot ensure that it is identifying or reviewing those materials that it would consider to be of the highest priority. This is unacceptable.

Kohl said he was concerned that staff and funding levels [at the FDA] have not kept up with the increase in advertisements. According to the GAO, drug company spending on DTC advertising increased twice as fast as spending on promotion to physicians or on the research and development of new drugs. The budget for the FDAs DTC review group has increased only slightly since its inception in 2002.

A copy of Kohls letter to President Bush is attached.

December 14, 2006

The President The White House Washington, DC 20500

Dear Mr. President:

I am writing to call your attention to the findings of a recent U.S. Government Accountability Office (GAO) report, issued at my request, on Direct-to-Consumer (DTC) advertising of prescription drugs. Given the GAOs findings, I respectfully request that you provide additional funding for the Food and Drug Administration (FDA) in your Fiscal Year 2008 budget request to enable them to effectively review and regulate DTC advertising of prescription drugs.

GAOs report, entitled PRESCRIPTION DRUGS: Improvements Needed in FDAs Oversight of Direct-to-Consumer Advertising, made several key findings and recommendations to the FDA to ensure consumer safety. Specifically, the GAO found that from 1997 through 2005, drug company spending on DTC advertising of prescription drugs increased twice as fast as spending on promotion to physicians or on research and development. In contrast, the budget for the FDA review group that polices DTC advertisements for content and accuracy has increased only slightly since its inception in 2002. As you know, funding for the DTC review group in 2006 was $1,039,000, an increase of only $299,000 since it was formed. Staff levels for this review group have essentially remained stagnant, with only seven staff members from 2002-2005, and eight in 2006. The staff and funding levels have certainly not kept up with the increase in advertisements they are charged with regulating.

The GAO also found that the FDA reviews only a small portion of DTC advertisements that reach the airwaves. Further, the FDA does not have formal criteria for prioritization and review of these ads and does not track information on its reviews. Therefore, the FDA cannot ensure that it is identifying or reviewing those materials that it would consider to be of the highest priority. This is unacceptable. The FDA cannot protect consumers from misleading or inaccurate advertisements if the ads themselves are not properly reviewed and tracked.

We must work together to ensure that consumers are receiving accurate information to protect their health. Part of that commitment is to provide government agencies with the proper oversight and tools they need to do their job. As you put together your budget request for Fiscal Year 2008, I urge you to include additional funding for the FDA to establish a system to effectively review and regulate DTC advertising of prescription drugs. Thank you for your attention to this important matter.

Sincerely,

Herb Kohl

Ranking Member

Special Committee on Aging