LAWMAKERS USE GAO REPORT TO PRESSURE BUSH ON DTC ADS
A bipartisan group of lawmakers is using a recent government report to pressure the Bush administration to increase funding for FDA oversight of direct-to-consumer (DTC) drug advertising and to institute a moratorium on ads for newly approved products.
The Government Accountability Office's (GAO) report, "Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising" studied issues including trends in drug company spending on DTC ads and the effectiveness of the agency's DTC enforcement. The report, released Dec. 14, described the system as needing reform.
The FDA's reviews are taking longer and becoming less effective, the report concluded. The agency also lacks a formal system for prioritizing its reviews to ensure that products with the greatest potential impact on public health are reviewed first. Furthermore, as drug companies spend more on DTC ads, evidence is beginning to pile up that these ads may lead to increased drug costs, the GAO found.
Consequently, the report recommended that the FDA formalize its criteria for prioritizing DTC reviews and consistently use those standards. The agency also needs to track the materials it reviews, the report added.
Several lawmakers are seizing on the report to push for legislative changes to the DTC program. Sen. Herb Kohl (D-Wis.) wrote a Dec. 14 letter to President Bush urging increased agency funding in the fiscal 2008 budget to allow the FDA to effectively review and regulate these ads. Kohl is expected to take over the Senate subcommittee that oversees the FDA's funding when Democrats take control in January.