Pharmaceutical Industry

FDA Pharmaceutical Companies Agree to Pact on TV Ads

NEW YORK - In health care marketing news, the Food and Drug Administration would charge a fee to pharmaceutical companies in exchange for accelerated review times for their TV advertisements, according to a report in the Wall Street Journal.

Fees from the pact would be used by the FDA to hire additional staff specifically for the review process. With the additional staff on board, the FDA hopes to review these health care marketing advertisements within 45 days of their submission by pharmaceutical companies.

The accord, which would take effect in the 2008 fiscal year (beginning October 2007) requires companies to pay $40,000 to $50,000 at the beginning of each year for each campaign they plan to air. This amount may be higher if few companies sign up and the FDA’s budget falls short of its target of $6 million in fees. Also, fees would be double for the first year of the pact in order to create a reserve fund.

The agreement, which is pending approval by both the Department of Health & Human Services and Congress, is being proposed at the same time as a new five-year pact setting user fees to be paid by pharmaceutical companies to the FDA when the bureau examines their applications to market new products.

Under that agreement the FDA is expected to collect approximately $400 million in user fees for fiscal 2008 compared to an anticipated $300 million in fiscal 2007. A large portion of this money will go to fund drug safety initiatives, according to the Journal. Other funds would be allocated for adding review staff, creating new drug development guidelines, improving IT systems and moving into a new office building.

The Division of Drug Marketing, Advertising, and Communication (DDMAC) reviewed 9,285 consumer promotions in 2005 - an increase of more than 10% from 2004. Moreover, it is believed that Direct-to-Consumer advertising has escalated in 2006 with the adoption of PhRMA’s DTC guidelines at the end of last year.