Drug firms to pay ad fee to FDA

Pharmaceutical companies have agreed to pay millions in new fees to help federal health officials step up the review of drug commercials before they are aired on television, the industry and government said Thursday.

Under the five-year plan, drug makers will pay the Food and Drug Administration a one-time fee plus additional charges for each commercial submitted. The fees, which will bring in about $6.25 million a year, will help fund the FDA’s monitoring of ads for misleading claims and other issues before they air.

The deal accompanies proposed legislation to renew other industry funding for FDA drug reviews through 2012. It includes $392.8 million in fees for fiscal year 2008. Similar charges would follow each year, along with adjustments. About $29.3 million in fees next year would target the agency’s drug safety system, which has come under scrutiny in recent years amid several withdrawals of medicines.

Those funds would be used to boost the FDA’s database for tracking drug use once products hit the market, as well as to access additional databases, the FDA said. They also would fund more staffing and research on how best to monitor side effects.

The 2008 fees include an additional $4 million for technology that would eventually allow drug makers to submit product applications electronically.

Fees were raised to keep up with inflation as well as deal with a higher workload, including the growing number of meetings involving FDA personnel and drug manufacturers, the agency said.