FDA Seeks US Pharma Cash to Review Drug Ads

15 January 2007

WASHINGTON DC: The Federal Drug Administration has asked the US Congress to ratify demands for pharmaceuticals companies to pay around $6.2 million (€4.8m; £3.18m) a year for improved scrutiny of direct-to-consumer advertising.

The request goes hand in hand with a draft proposal by the FDA to increase fees for medicine reviews by 29%, to $392.8 million a year, under the renewal terms of the Prescription Drug User Fee Act (PDUFA).

The increase would boost the regulator's oversight of the safety of drugs already on the market, allowing it to add 82 new staff.

Payments to speed up reviews of DTC ads before they air on television were mooted last year [WARC News: 22-Nov-06] following the Pharmaceutical Manufacturers Association of America's adoption of voluntary advertising guidelines.

The fees would pay for the hiring of 27 extra FDA employees to look at the TV ads within 45 days. However, the pharmas still would not be required to submit their ads for review.

The FDA currently has a limited ability to curb distribution of drug ads that violate federal rules, according to a recent report by government auditors [WARC NEWS: 15-Dec-06].

Comments Billy Tauzin, president/ceo of PhRMA: "The PDUFA proposals from America's pharmaceutical research companies and the Food and Drug Administration call for comprehensive improvements in all areas that are essential to timely, safe and effective use of new medicines by millions of American patients."

Consumer groups are not so impressed amid concerns that such reviews cannot be truly independent if they are funded by the drug manufacturers.

Says Dr Sidney Wolfe, director of advocacy group Public Citizen: "The FDA's crucial drug-regulatory functions are too important to be tainted and compromised by direct funding from the very companies whose drugs the agency reviews for safety."

He adds: "The money should come from the federal Treasury, not the pharmaceutical industry."

Data sourced from AdAge.com; additional content by WARC staff