Mid-July 2017, the United States Food and Drug Administration held a public meeting to discuss options and steps to encourage innovation in drug development and accelerate consumer access to generic drugs. FDA believes that attempting to strike such a balance will speak to Congress’ initial intent when it enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments).
FDA Commissioner Scott Gottlieb opened the meeting with a discussion of the Agency’s position and the announcement of the intended 2017 release of two new documents to improve the generic approval process as part of his Drug Competition Action Plan announced earlier this year.
The first document, a Good ANDA Assessment Manual of Policy and Procedures (MaPP), will be an internal CDER policy to streamline the ANDA review process inside FDA without lowering approval standards. As part of this MaPP, Complete Response Letters will make clear what aspect of the application needs improvement to obtain approval.
The second document is a Good ANDA Submission Practices Guidance, which will point out common recurring deficiencies in ANDA and provide advice on avoiding them in an effort to ensure better higher quality submissions.
During the meeting, several of the participants discussed the effect of patent and exclusivity periods, regulatory review timelines, insurance reimbursement practices, the number of generic competitors and timing of generic entry, and other market forces on the price of branded and generic prescription drugs.
Many presenters focused on specific FDA regulations that disturb ease of generic entry, pay-for-delay settlements, sham litigation, and other activities undertaken by industry participants that some speakers characterized as abusive and anti-competitive.
Several presenters discussed features of the statutory and regulatory framework that they believe has allowed innovator companies to “evergreen” their products: to extend patent or regulatory exclusivity periods by seeking approval for ostensibly modest product changes. Presenters debated whether certain changes provide patients with additional value and whether agency resources should be allocated to prioritize the review of new therapies over the review of incremental changes to existing products.
Another topic examined was the number and success rate of “blocking” petitions filed by innovator companies. Participants discussed whether innovator companies have used the citizen petition process to delay generic entry by raising objections that are not scientifically valid or do not raise important public health issues. Industry stakeholders defended the petition process as an important vehicle that allows petitioners to raise legitimate scientific issues.
While the FDA spent the day listening to input, panelists acting on behalf of the FDA asked the presenters to provide specific recommendations on changes they feel the agency can implement to encourage innovation and competition, while avoiding unnecessarily spending resources and remaining within the FDA’s regulatory authority. The public docket for comments closes on September 18, 2017.