Who Pays for for Scrutiny of US D-T-C Pharma Ads?

26 February 2008

WASHINGTON DC: The debate over who should foot the bill for vetting direct-to-consumer pharmaceutical ads is still a vexed question - both for America's federal government and the drugs industry - despite this year's record level of funding for the Food and Drug Administration.

The $6.1 million (€4.1m; £3.1m) available to check the fairness and accuracy of DTC ads will used be for the hiring of extra staff to look at more material.

The FDA has long lobbied for an increase in resources, complaining it is overwhelmed by the amount of unchecked pharmaceutical marketing reaching consumers.

In the past, the regulator has declared some TV campaigns to be misleading only after they have already aired. The new funding is intended to hasten the scrutiny process.

However, the outgoing Bush administration is still seeking alternatives to government money for this purpose, in the shape of increased user fees levied on the pharma giants.

Under the terms of the Prescription Drug User Fee Act, the companies would pay around $14 million to the FDA in 2009 to employ 27 new staff. This should enable the watchdog to review TV drug ads within 45 days of receipt from drug firms.

These proposals are backed by trade association, the Pharmaceutical Research and Manufacturers of America, which already pays some user fees to the FDA for reviews of new human and animal drugs and medical devices.

If adopted by Congress, 25% of ad review funding for 2009 would come from manufacturers.

However, many legislators and health lobby groups are opposed to the measures, believing they would allow the pharma firms too much sway over the scrutineers.

One of the most vocal opponents is Democrat congresswoman Rosa DeLauro, who chairs a subcommittee overseeing FDA funds.

She maintains: "I believe Congress should provide a direct appropriation in order to minimize industry influence in the FDA."

Data sourced from USA Today.com; additional content by WARC staff