FDA To Hold Public Meeting in July on Generic Drug Review Process

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-22-2017 12:57


The US Food and Drug Administration (FDA) will hold a public meeting on July 18, 2017 to discuss ways to improve the generic-drug review process. The public meeting is part of an effort to create a broader understanding of the interplay between the existing legal and regulatory framework, available incentives and marketplace practices, and consumer access to generic drugs.

In a blog posted on the FDA website, FDA Commissioner Scott Gottlieb outlined that the meeting is part of a larger process by the FDA in creating a Drug Competition Action Plan. "As part of this effort.., we’re announcing in the Federal Register our intent to hold a public meeting on July 18, 2017, to solicit input on places where FDA’s rules–including the standards and procedures related to generic drug approvals–are being used in ways that may create obstacles to generic access, instead of ensuring the vigorous competition Congress intended."

In the Federal Register notice, the FDA is particularly interested in stakeholder input to evaluate if the proper balance between encouraging drug innovation and developing access to lower-cost generic drugs, as provided by the Drug Price Competition and Patent Term Restoration Act of 1984 (i.e., the Hatch-Waxman Amendments), has been affected by practices and trends. The meeting seeks input to that question as it relates to exclusivity periods, patents (including patent listing procedures), innovator drug product labeling, post-approval changes to innovator drug products (e.g., reformulations), and other regulatory processes, including the citizen petition process.

The FDA is also interested in stakeholder input on whether marketplace dynamics disincentivize the marketing of approved generic products and what the FDA should do within its statutory authority to help more approved generics reach consumers.

The FDA is also looking at ways to encourage entry of generic drugs for niche product areas. The FDA estimates that for approximately 10% of all innovator drugs, patent and exclusivity protections have expired, but the FDA has not received an abbreviated new drug application (ANDA). The FDA is seeking input to see if there are market niches where the Hatch-Waxman Amendments incentives to develop an ANDA are insufficient. Similarly, the FDA is interested to see if there are there niches where the incentives are insufficient to seek new drug approval of a marketed unapproved drug product that in turn could serve as a Reference Listed Drug (an approved drug product to which new generic versions are compared to show that they are bioequivalent), and what can the FDA can do to encourage submission development in any such market niches.

The FDA is also looking at ways to mitigate issues that may arise in the Risk Evaluation and Mitigation Strategies (REMS) process. The FDA noted that the statutory requirement that REMS include elements to assure safe use requires a single shared system that relies on brand and generic companies agreeing on such a system before generic drugs may come to market. In some cases, noted the FDA in the Federal Register notice, challenges in reaching such an agreement between the parties may cause delays to generic competition, and the FDA is seeking input on how to apply its statutory authority to waive this requirement to implement a single shared system or develop other administrative tools to avoid these delays.

The FDA further noted that restrictions on distribution, either required by innovators or as part of a REMS process, can prevent generic companies from obtaining drug products for bioequivalence and other testing to support ANDA submissions. The FDA wants to examine ways in which it can facilitate access to these testing samples for ANDA submissions.

In addition to the July public meeting, the FDA is seeking written comments until September 18, 2017.

Source: Federal Register


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