§379h–1 Fees Relating to Advisory Review of Prescription-drug Television Advertising

Summary

Requires companies to pay fees when they ask the FDA for optional advice on TV ads for prescription drugs starting in fiscal year 2008. Each year the FDA will ask by June 1 how many ads a company plans to submit, and the company must tell the FDA within 30 days. Advisory review fees are due by October 1 of the fiscal year when the ad will be submitted (for fiscal year 2008 the fee is due within 120 days after September 27, 2007, or earlier if the FDA says). If a company pays late or sends more ads than it told the FDA, each late or extra fee becomes 150% of the normal fee and must be paid 20 days before submitting the ad. Each fee covers one original submission and one resubmission of the same ad, and a company may carry over at most one paid submission to the next year. Fees normally are not refunded, and the FDA cannot waive or cut them. The fee program must raise $6,250,000 each year for fiscal years 2008–2012, with yearly adjustments starting in 2009 for inflation and workload. After inflation, the workload increase is $27,600 for each ad above 150 in a year (this $27,600 is also inflation-adjusted). The FDA sets the per-ad fee each year by August 1; the FY2008 per-ad fee cannot be more than $83,000, and after 2008 a fee cannot jump more than 50% above the prior year. The FDA must keep an operating reserve (at least $6,250,000 in 2008) and charge a one-time operating reserve fee to new participants. If total initial collections are under $11,250,000 by the startup deadline, the program won’t start and fees are returned. From 2009 on, the program stops if available funds drop below $9,000,000 (inflation-adjusted). Submissions are incomplete until all owed fees are paid, and fees are available only as Congress provides the money. Defined terms in one line each: “advisory review” means FDA review and comments before public airing; “advisory review fee” is the fee for that review; “carry over submission” is a paid submission moved to the next fiscal year; “direct-to-consumer television advertisement” means a prescription drug TV ad under 3 minutes; “resubmission” is a revised ad sent after FDA comments; “operating reserve fee” is the one-time reserve charge for new participants; “person” includes people and companies; “process for the advisory review” means the FDA work to review ads; “resources allocated” means the staff, contractors, IT, facilities, and other costs needed to run the review; “submission for advisory review” means a voluntary original request for FDA comments.