WASHINGTON DC: After months of delicate negotiations, US pharmaceutical companies and the Food and Drug Administration have reached a provisional accord that will see drug firms pay to obtain fast-track approval of their TV advertising.
Although the agreement has to be ratified by Congress, it seems likely it will go hand in hand with a pact whereby pharmas pay more to the FDA to review new medicines. The money will fund drug safety initiatives.
The proposed agreement on fast-track fees would see pharmas hand over between $40,000 (€31k; £21k) and $50,000 to the FDA at the beginning of every year for each ad campaign they plan to air.
The amount could be higher if fewer companies sign up and the FDA faces a shortfall against its annual target of about $6 million in total collected fees.
Drug marketers would pay more in year one to create a reserve fund. In return, the FDA would undertake to review and rule on all TV ads within 45 days.
The pharma industry has been under intense pressure to clean up its direct-to-consumer advertising act following high profile safety debacles such as Vioxx.
Many Democrat politicians have been pressing for legislation to curb the worst excesses of DTC ads, while the industry has been resisting equally fiercely through a variety of self regulation plans.
The Pharmaceutical Research and Manufacturers of America has put forward a set of voluntary guidelines for DTC advertising, but must now wait to see if these will be enough to satisfy the newly empowered Democrats [WARC News: 13-Nov-06].
Data sourced from Wall Street Journal Online; additional content by WARC staff