Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

FDA Statement

• For Immediate Release: October 02, 2018
• Statement From: Scott Gottlieb, M.D.

When I announced the Drug Competition Action Plan, or DCAP, in June 2017, I committed the FDA to a number of new steps to increase competition in the market for prescription drugs and to help facilitate the entry of lower-cost alternatives to improve patient access to affordable medicines.

One area of focus has been shutting down practices used by branded firms to “game” the system and take advantage of certain rules, or exploit loopholes, to delay generic approval – thereby extending a drug’s monopoly beyond what Congress intended. One of the most common tactics we’ve taken aim at are instances when branded firms make it hard for generic manufacturers to get access to physical doses of a branded drug. Generic manufacturers need anywhere from 2,000 to 5,000 doses of the branded drug in order to run studies to prove their generic medicine is the same as the branded drug. Such practices upset the careful balance that Congress sought between product innovation and access. They can make the development and approval process unpredictable, and potentially more costly, for generic manufacturers.

Another one of these anticompetitive techniques of concern to me involves the use of citizen petitions that are subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act. Many have argued that these petitions block generic entry. While the record shows that citizen petitions have rarely delayed specific generic drug approvals, there’s no doubt that the process requirements associated with 505(q) petitions can add to resource burdens on the generic drug review process and the FDA’s regulatory decision making. This increased burden on the FDA can take resources away from the daily work of application review. A key to improving the speed and predictability of the generic drug review process – and reducing the multiple cycles of review many applications undergo – is to improve our own review process efficiency.

To address these goals, today, the FDA has issued a revised draft guidancedesigned to allow for a more efficient approach to 505(q) petitions and allow us to focus more reviewer resources on scientific reviews.

This revised draft guidance, which will be finalized after an opportunity for public comment, describes some of the factors the FDA will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a generic drug application. If the agency determines that this is the case, the FDA will consider whether the petition can be denied on that basis and may in any case note this determination in the petition response. The agency’s determination will be part of the petition response, a public document available through the citizen petition docket. We believe this will provide an additional deterrent to pursuing these tactics.

To further dissuade companies from improperly using these petitions, the FDA also intends to highlight in our annual report to Congress our determinations of petitions that are judged by the agency to have been submitted with the primary purpose of delaying an approval. Importantly, the guidance also outlines our intention to refer these matters to the Federal Trade Commission. This is the agency that oversees anticompetitive business practices. We will not shy away from calling out instances where we believe brand firms may be leveraging tools intended to serve a useful purpose to instead thwart competition that can drive down prices for patients. We’re taking the abuse of this system seriously. And we hope that this increased transparency will reduce gratuitous hurdles to generic drug development and approval.

The revised draft guidance also seeks to lessen the impact that our review of petitions may have on any pending approval actions. Our new approach would help the FDA focus our resources on addressing petitions that are most likely to present an obstacle to the availability of generic drugs. Once an application is submitted, the FDA has a goal date of making an approval decision on that application within 10 months, or, for some priority applications, within eight months. If a citizen petition is received while a product application is already under review, and if the goal date for that review falls within the next 150 days, the draft guidance states that the FDA would expect to respond to that petition within 150 days. This policy aligns the FDA’s 150 day timeline to review and respond to these petitions described in federal law with the timeline for review of the applications themselves. We will continue to ensure that any scientific and regulatory issues raised in a petition are considered prior to the product approval. Sometimes citizens petitions can raise relevant concerns. This new approach will help reduce approval decision delays in certain scenarios simply because a citizen petition has been submitted.

By addressing challenges associated with the 505(q) citizen petition process we aim to provide greater regulatory certainty, improve the efficiency and predictability of the generic drug review process, and help to drive down costs of generic drug development and create incentives for new market entrants. These efforts build on the other steps we’ve taken under DCAP to improve the efficiency of our generic drug review process. These steps include issuing guidance documents and other agency directives intended to improve generic drug submissions and reduce review times, which can help to make sure more generic applications that gain FDA approval do so on their first cycle of review. Increasing the percentage of generic applications approved on the first cycle of review is a key goal of our continued efforts. In 2017, the FDA approved or tentatively approved more than 1,000 generic drug applications, a record for our agency. In 2018, we are on track for similar success. We have completely eliminated our pre-user fee backlog of generic applications. We’ve also published guidance to help developers of complex generic drug products and have prioritized the review of generic applications for products with little competition.

We know there’s no easy or single solution to the challenges posed by high drug development costs and the high prices that result from these and other factors. But we also know that by continuing to strengthen and effectively apply our policies and regulations, and by developing and strengthening our scientific and clinical standards to address the issues raised in citizen petitions, we can make additional, new headway in helping to promote competition, reduce prices and enable more patients to have access to medicines.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.