3 October 2017Americas

FDA issues new guidance to boost generic competition

The US Food and Drug Administration (FDA) has issued new guidance as part of its bid to target the barriers to generic drug competition.

In June this year, the FDA announced its intention to target the barriers by “facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines” via its drug competition action plan.

Soon after, Scott Gottlieb, the FDA’s managing director, revealed plans to increase competition in the US market for prescription drugs, as well as to facilitate the entry of generic drugs into the market.

The FDA implemented a policy aimed at expediting the review of generic drug applications. The administration will expedite review until there are three approved generics for a given drug.

In a blog post, published yesterday, October 2, Gottlieb introduced two news sets of guidance aimed at ensuring the FDA provides “as much scientific and regulatory clarity as possible with respect to complex generic drugs”.

The first set of draft guidance will assist those seeking Abbreviated New Drug Applications (ANDAs) in creating and submitting pre-ANDA meeting requests, so that the FDA can provide better advice to branded drug companies.

“These meetings will allow for enhanced communication between generic drug applicants and FDA early in the generic drug development process, allowing for more efficient generic drug development, review, and approval pathways,” said Gottlieb.

The second set of guidance is aimed at helping applicants determine when the submission of ANDAs for certain complex products (peptides) would be appropriate.

Gottlieb summarised: “In other words, because brand-name versions of complex drug products are often higher-priced than many other brand-name drugs, any steps we can take to encourage the development of generic competitors to complex drugs will have an outsized impact on access, and prices.”

In September, LSIPR reported that the FDA had cleared the backlog of orphan drug designation requests, one month early.

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28 June 2017   The US Food and Drug Administration has revealed plans to increase competition in the US market for prescription drugs, as well as to facilitate the entry of generic drugs into the market.
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Americas
26 June 2017   The Food and Drug Administration has announced its intention to target the barriers to generic drug competition.
Americas
28 June 2017   The US Food and Drug Administration has revealed plans to increase competition in the US market for prescription drugs, as well as to facilitate the entry of generic drugs into the market.
Americas
3 January 2018   The US Food and Drug Administration revealed additional steps aimed at encouraging generic competition today.