21 U.S.C. § 379h–1 — Fees relating to advisory review of prescription-drug television advertising

(a) Types of direct-to-consumer (DTC) TV ad review fees. Starting fiscal year 2008, the FDA (called "the Secretary" here) must assess and collect these fees. (1) Advisory review fee. Anyone who, on or after October 1, 2007, submits a proposed DTC TV drug ad to FDA for voluntary advisory review before it's first shown to the public owes a fee, with the amount set under subsection (c)(3) — unless the ad's submission was legally required anyway, in which case no fee applies unless the sponsor specifically asks for advisory review. By June 1 each year, FDA must publish a Federal Register notice asking companies to tell FDA, within 30 days, how many DTC ads they plan to submit for review the next fiscal year; for fiscal year 2008, this notice had to run within 30 days after September 27, 2007. The fee is due by October 1 of the fiscal year the ad is intended for, or, for fiscal year 2008, within 120 days of September 27, 2007, or earlier if FDA specifies. Telling FDA how many ads a company plans to submit is a legally binding promise to pay for that many by the due date. When giving that estimate, a company must also flag any ad it intends to submit that already has a fee paid from a prior year, a "carryover"; if it doesn't flag this, every ad it submits that year gets charged the fee. The fee can rise: if a company that gave FDA an estimate hasn't paid all its fees by November 1 of that fiscal year, or the equivalent 2008 deadline, all its fees for that year become due 20 days before it submits any ad for review, and each fee rises to 150 percent of the normal amount. Likewise, submitting more ads in a year than originally estimated means each excess ad is charged 150 percent of the normal fee, due 20 days before submission. Paying one advisory-review fee buys review of one ad plus one resubmission of that same ad; the ad must be submitted in the fiscal year the fee was assessed for, except a company may carry over one paid submission to the next fiscal year, and resubmissions aren't tied to a fiscal year. Except in narrow refund situations under subsections (d)(4) and (f), fees are never refunded, FDA can't waive, exempt, or reduce any fee, and the right to a paid-for advisory review can't be transferred to someone else, except to a successor company. (2) Operating reserve fee. Anyone charged an advisory review fee also owes an "operating reserve fee," but only in the first fiscal year they're charged an advisory review fee, not in later years. It's due by October 1 of that first year, or the equivalent 2008 deadline — except that if, in that first year, the company submits more ads than it originally estimated, it owes an extra operating reserve fee, equal to the increased advisory-review fee, for each excess ad, due 20 days before submission, on top of the regular fee. This fee also becomes late, and jumps to 150 percent of the normal amount, due 20 days before any submission, if not fully paid by November 1, or the equivalent 2008 deadline. (b) Advisory review fee revenue amounts. Fees must be set to raise $6,250,000 total for each of fiscal years 2008 through 2012, subject to the adjustments in subsections (c) and (g)(4). (c) Adjustments. Starting fiscal year 2009, FDA must adjust the revenue target each year to reflect whichever is greatest of: the change in the national Consumer Price Index over the 12 months ending the prior June 30; the prior year's percentage raise in federal General Schedule pay with D.C.-area locality pay; or the average yearly change in FDA's per-employee personnel costs over the first 5 of the previous 6 fiscal years. Each year's inflation bump compounds on top of all previous years' bumps since fiscal year 2008. Starting fiscal year 2009, after applying the inflation adjustment, FDA further adjusts revenue for changes in its DTC-ad review workload: it multiplies $27,600, itself inflation-adjusted each year, by however many projected ads from companies' estimates, not counting paid carryovers, exceed 150, and publishes the resulting fees and methodology in the Federal Register. This workload adjustment can never push revenue below the prior year's level. By August 1 each year, or within 90 days of September 27, 2007, for fiscal year 2008, FDA must set the coming year's per-ad advisory review fee by dividing that year's adjusted revenue target by the number of ads companies estimated, excluding paid carryovers. For fiscal year 2008, this fee can't exceed $83,000 per ad. For later years, it can't rise more than 50 percent above the prior year's fee. Total fees actually spent in a year can't exceed FDA's real costs that year for the ad-review process. (d) Operating reserves. FDA must set up a "Direct-to-Consumer Advisory Review Operating Reserve" fund, at least $6,250,000 in fiscal year 2008, to keep the program running if a year's actual fee collections fall short of the target. The operating reserve fee for each company is the number of ads it estimated times that year's advisory review fee, but never less than what it would have owed had it first joined the program in fiscal year 2008. FDA can tap the reserve only to cover shortfalls between the target and actual collections, or to wind the program down if it ends. Within 120 days after fiscal year 2012 ends, or after an early program shutdown under subsection (f), FDA must refund the leftover reserve, pro-rated among everyone who paid an operating reserve fee, capped at what each person actually paid in. (e) Effect of failure to pay fees. If a company owes fees under this section, its ad-review submission is treated as incomplete and won't be accepted for review until every fee it owes is paid. (f) Effect of inadequate funding. If, by November 1, 2007, or 120 days after September 27, 2007, whichever is later, FDA hasn't collected at least $11,250,000 total in advisory review and operating reserve fees, the program never starts and all fees collected are refunded. Starting fiscal year 2009, if on November 1 the combined total of the reserve, that year's fee revenue, and any leftover revenue from earlier years falls below $9,000,000, inflation-adjusted, the whole program ends. FDA must notify everyone, keep only what's needed to shut the program down — using unobligated prior-year fees first, then the reserve, then that year's unused fees — and refund the rest. (g) Crediting and availability of fees. Fees can only be collected and spent to the extent Congress appropriates in advance; once appropriated they stay available until spent, and money can move between FDA's general and program-specific accounts, but only for the DTC ad-review process. Fees are capped each year at the appropriations-law amount, and are usable only if that year's budget supports at least as many full-time review staff, in the specified FDA drug-marketing and biologics-advertising divisions, as existed in fiscal year 2007. For fiscal years 2008 through 2012, Congress is authorized to appropriate the full adjusted revenue target, plus the reserve-fund contributions. Any year's fee collections that exceed what the appropriations law specified get credited to FDA's account as described above, but get subtracted from what the program is otherwise allowed to collect in a later year. (h) Definitions. "Advisory review" means reviewing and commenting on a DTC ad's compliance before it's first shown publicly. "Advisory review fee" is defined in (a)(1)(D). A "carry over submission" is a paid-for review submitted the year after the fee was paid. "Direct-to-consumer television advertisement" means a TV ad, under 3 minutes, for a prescription drug as defined in section 379g(3). "DTC advertisement" is defined in (a)(1)(A). "Operating reserve fee" is defined in (a)(2)(A). "Person" includes individuals, partnerships, corporations, associations, and their affiliates or successors. "Process for the advisory review of prescription drug advertising" covers the review-and-comment work itself, plus, if extra staff capacity allows, similar review of other promotional material. "Resources allocated" to that process covers FDA staff, contractors, and advisory committees and related costs; information technology and computer resources; leasing, facilities, and equipment; fee collection and accounting; and the costs of shutting the program down under (f) if needed. A "resubmission" is a revised ad resubmitted in response to FDA's comments, and it can't introduce major new concepts or creative themes. A "submission for advisory review" is an original ad submitted voluntarily by its sponsor for comments before public release.