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FDA Releases Draft Guidance to Stimulate Generic Competition for Branded Drugs


The FDA released draft industry guidance for its pathway aimed at providing incentives to stimulate competition for branded drugs that have few or no generic counterparts in the marketplace. Separately, it also updated its “name and shame” list.

The FDA released draft industry guidance for its pathway aimed at providing incentives to stimulate competition for branded drugs that have few or no generic counterparts in the marketplace.

The draft guidance outlines the criteria and timing to designate a drug as a competitive generic, the process for submitting the request, the considerations for expedited development, actions the FDA might take to expedite development and review, and determining exclusivity for the generic.

A drug can move along the competitive generic therapies (CGT) pathway when there is not more than 1 approved drug in the active section of the Orange Book. The designation, set by Congress when it granted the FDA new authorities in the FDA Reauthorization Act of 2017, provides certain incentives for industry to develop generics for drugs lacking competition that have been designated as CGTs.

In a statement, FDA Commissioner Scott Gottlieb, MD, called it “a significant advancement in generic drug competition.” He also said that over the next year, additional policies to promote competition will be released, including for complex drugs.

To date, the FDA has granted more than 100 CGT designation requests, according to the FDA. Last year, between August and December, the FDA approved the first 5 abbreviated New Drug Applications (ANDAs) for generic drugs designated as CGTs.

The CGT pathway “is efficient and effective at promoting new competition. It’s also a key step in making safe and effective generic drugs available to patients quickly while helping to ensure there’s adequate competition in the market place, so patients have access to the treatments they need,” Gottlieb said.

The FDA said the designation has a number of benefits, such as:

  • Product development meetings to discuss specific scientific issues with FDA staff or ask questions about proposed study design or alternative approaches
  • Reducing the number of application review cycles, in turn decreasing the time it takes for the generic drug to receive approval
  • If a CGT designation is granted, the application may be eligible for a 180-day period of marketing exclusivity provided, if the sponsor is the first approved ANDA for that CGT and meets other conditions.

Separately, the FDA also updated its list of companies that have restricted access to samples of small-molecule drugs for testing through the use of Risk Evaluation and Mitigation Strategies (REMS) programs or limited distribution of their products.

The so-called “name and shame” list was first unveiled in May 2018. According to the FDA, there have been 9 new inquiries listed or submitted since the list fist published.

In addition, there have been 3 new safety determination letters issued, bringing the total to 24, and 1 additional drug product (tolvaptan, sold as Jynarque) listed which had a REMS Elements to Assure Safe Use impacting distribution to potential generic competitors. Tolvaptan is used to treat low blood sodium.

The number of drug products listed rose from 51 to 54. Besides tolvaptan, the others were the antiparasite drug pyrimethamine (Daraprim) and tiopronin (Thiola), which is used to treat cystinauria.

REMS programs, which manage potential risks of a drug, have come under scrutiny as potential avenues for anticompetitive behavior in the marketplace. Some stakeholders warn that REMS programs are used by some drug makers to improperly withhold samples of products for testing by biosimilar or generic drug developers, even in cases in which the FDA has informed a drug company in writing that it will not consider provision of samples to be a violation of a REMS program.

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