Healthy Skepticism Library item: 7183
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Drugmakers' payments to FDA for reviews to increase by 29%
The Chicago Tribune 2006 Nov 22
http://www.chicagotribune.com/business/chi-0611220235nov22,0,3142007.story?coll=chi-business-hed
Abstract:
Drugmakers have agreed to a nearly 29 percent increase in payments to federal regulators to ensure speedy approvals of new medicines and step up safety monitoring, a person familiar with the deal said Tuesday.
Representatives of drugmakers and their trade associations also agreed for the first time to pay fees to have their consumer television commercials reviewed in advance by the Food and Drug Administration, the person said.
The terms are spelled out in agreements between the industry and the FDA that are subject to approval by the Bush administration and Congress.
The FDA wants to use some of the extra money to step up safety monitoring of drugs after they go into use. Lawmakers have criticized the agency’s performance after antidepressants were linked to increased risk of suicide and painkillers such as Vioxx were tied to heart attacks and strokes. The new fees would be part of the renewal of a 14-year-old law that expires next year.
The drugmaker payments make it impossible for the FDA to be a “vigilant regulatory agency,” said Sidney Wolfe, director of the health research group of the consumer group Public Citizen. “The whole thing needs to be repealed.”
Public interest groups say the FDA’s $1.88 billion budget is inadequate for it to provide sufficient oversight of drugs. The FDA also regulates medical devices, food and cosmetics.
Alan Goldhammer, an official with the Pharmaceutical Research and Manufacturers of America, one of the trade groups that participated in the negotiations, declined to comment. The group told the FDA it would not discuss the agreement until the agency makes it public.
Stephanie Fischer, a spokeswoman for the Biotechnology Industry Organization, also involved in the talks, declined to comment, citing a confidentiality agreement with the FDA. An FDA spokeswoman also declined to comment.
Payments to the FDA for new-medicine applications would increase by at least $87.3 million, to $392.8 million, in the 2008 fiscal year, which starts Oct. 1, 2007, the person said.
About $30 million of the increase would be spent to upgrade the agency’s monitoring of drug safety, according to the source. The FDA hopes to use some of the funds to improve detection and evaluation of harmful side effects after drugs are on the market.
User fees now represent about 60 percent of the agency’s drug-review budget. The amount collected in the fiscal year starting Oct. 1, 2007, will probably be higher than $392.8 million, based on the agency’s workload in coming months, according to the person familiar with the talks. The fee for each new-medicine application will depend on how many drugs the agency is asked to review.
Under a separate agreement drugmakers would pay $6.25 million in the 2008 fiscal year to fund FDA reviews of consumer ads before they air. The FDA already vets commercials on a voluntary basis at no charge.
