FDA announce generics regulatory streamlining

The US Food and Drug Administration (FDA) has announced new guidance for the generic drug approval process through the release of two documents that will be closely scrutinized by generic pharma law firms and right across the generics industry.

The documents form part of the FDA’s Drug Competition Action Plan, designed to speed up the generics approval process for Abbreviated New Drug Applications (ANDAs).

One document is entitled ‘Good ANDA Submission Practices’ and offers guidance to generics producers, including an outline of the typical problems that can cause delays in the ANDA process. The FDA found that an average ANDA takes four cycles to gain approval, often because of a deficiency in the application rather than in the product itself.

According to Scott Gottlieb, FDA commissioner, the organization is committed to reducing the number of review cycles in order to increase generic competition:

“Through today’s guidance, as well as others from the agency, we can achieve one of the FDA’s key goals in 2018 — to reduce the number of review cycles by helping applicants avoid these common deficiencies that lead to review delays and application cycling.”

Together with the draft guidance, the FDA has also put out a Manual of Policies and Procedures (MAPP) entitled ‘Good ANDA Assessment Practices’ offering guidance to FDA staff on the evaluation of ANDAs. The MAPP will streamline the assessment process and provide templates to speed up each review cycle. It will also require the FDA to liaise with generics companies in a more intensive way and to provide more detailed guidelines for companies on what information should be provided in each application cycle.

According to Gottlieb, the measures that the FDA brought in during 2017 have begun to take effect. November 2017 saw the biggest number of generic drug approvals since the FDA was founded, and it is also likely that the FDA will step up its efforts to encourage more generic competition during 2018. Efforts to speed up the approval of complex generic products and measures to combat the delaying tactics used by some brand-name manufacturers are in the pipeline, as rising health care costs continue to be a hot political topic in the US.




In today’s fast-growing, highly regulated generic pharmaceutical market, companies increasingly require specialized legal guidance as their products are developed, launched, and litigated. Wilson Sonsini Goodrich & Rosati’s attorneys address this need by providing expert counsel to companies in the global generics industry, offering sophisticated representation far beyond the scope of general corporate and securities counsel.

We have assembled a highly experienced team of experts from a cross-section of the firm’s key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Led by the former chief legal officer of Mylan Pharmaceuticals, one of the world’s leading generic and specialty pharmaceutical companies, our attorneys work closely with our generic pharmaceutical clients’ legal and scientific personnel and senior management to understand and meet their specific needs both in the U.S. and abroad.

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