DTC User Fee Program Suspended By Congress; FDA Gets More Review Funds
This article is reprinted from "The Pink Sheet" – January 7, 2008
Congress has increased the amount of federal money available to fund FDA review of direct-to-consumer television ads rather than appropriate user fees negotiated by FDA and industry to speed up the ad review process.
The FDA Amendments Act authorized $6.5 million for the review program. But the fiscal year 2008 omnibus appropriations legislation signed into law Dec. 26 by President Bush does not appropriate the money for FDA to spend.
Instead, the law increases by $4 million the amount of funds available from the U.S. Treasury for ad review. This will bring spending for the program to $6.5 million, a House staffer told "The Pink Sheet."
The action reflects House members' concern that user fees give the impression drug makers are buying FDA approval (1"The Pink Sheet" July 23, 2007, p. 14).
One problem with providing more money from the Treasury is that it is available for only one year, Pharmaceutical Research and Manufacturers of America Deputy VP-Regulatory Affairs Alan Goldhammer said in an interview.
"If they don't get an equal appropriations next year, they will have hired people and then have no money to pay them in fiscal 2009." The user fee program was crafted "not only to adjust for workload, but to make sure the program would stay up and running."
FDA's Division of Drug Marketing, Advertising and Communications is "evaluating the recently passed appropriations law and its effect on the user fee program and will provide information about the status of the program as soon as we are able," the agency said.
DDMAC received commitments from industry to submit 151 ads for review at a cost of $41,390 each. Without the appropriations language, there will be no need to invoice firms (2"The Pink Sheet" Dec. 17, 2007, In Brief).
- Cathy Dombrowski
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