US Congress Seeks More Control Over $4.1bn DTC Drugs Ads

30 May 2006

The US government has expressed its concern at the under-regulation of America's direct-to-consumer pharmaceutical-advertising category, worth an estimated $4.1 billion (€3.22bn; £2.21bn) annually.

Members of Congress are campaigning to allow the Food & Drug Administration to mandate studies ensuring the safety of prescription drugs after they reach the market. The move will prove unpopular with the pharmaceutical industry which, until now, has made most of the running in setting rules for d-t-c drug advertising.

Under the proposed legislation, the FDA would be able to demand further clinical studies, even years after a drug receives approval, enabling it to order the withdrawal of a drug from the market if its maker fails to comply with the demand; even suspend multimillion-dollar ad campaigns and halt sales of blockbuster drugs.

The political will for change follows last month's critical report from the Government Accountability Office which found that "the FDA lacks clear and effective processes for making decisions about, and providing management oversight of, post-market safety issues."

It also criticized the FDA for failing to press pharma companies on post-market studies, doing so only "sometimes". On those occasions when it did make such requests between 1991 and 2003, only some 25% of the studies were completed. "The FDA needs greater authority to require such studies," concluded the report.

Such authority could have been mandated last week by the House Appropriations Committee but for the intervention of the Republican representative for Georgia, Nathan Deal, who raised a point of order that the committee lacked any procedural right to grant the FDA that authority.

According to the American Public Health Association, Deal has an interesting voting record on healthcare issues. On the eleven occasions between 1999 and 2006 when healthcare issues were debated, Deal came down each and every time in favour of the private health sector and Big Pharma.

But despite Rep Deal's efforts, the drug testing issue is blocked only temporarily, believes Peter Pitts, former associate FDA commissioner for external relations. "This has broad, bipartisan support," he said.

Data sourced from AdAge (USA); additional content by WARC staff