Life Science Compliance Update

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July 13, 2017

FDA Drug Approvals on an Uptick

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Already in 2017, the FDA has approved a number of new drugs, which Regulatory Focus points out as a trend away from the low number of new drugs approved in 2016. They caution, however, it is unlikely to match the approval highs from 2014 and 2015. The pace for 2017 may not continue at this level and we could see an average, or perhaps slightly above average year for approvals.

2017 vs. Past

It has been reported that coming into 2017, the environment was looking better for approvals. According to the FDA’s Office of New Drugs, 36 new molecular entity NDAs were received by FDA through mid-December 2016, already beating the average number of 35 for the past decade.

The FDA, which approved 22 treatments last year, has given its approval to 21 drugs so far in 2017 including 3 in May. Key approvals so far in 2017 include Regeneron/Sanofi’s Kevzara (rheumatoid arthritis), Roche’s multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, and BioMarin’s Brineura (treatment of a specific form of Batten disease) among others. Some of these drugs have blockbuster potential.

Why the low number in 2016?

John Jenkins, the now-retired director of FDA’s Office of New Drugs, offered the explanation that the lower number in 2016 may not be a clear signal that industry innovation is stalling.

Jenkins wrote: “For example, CDER approved five novel drugs in 2015 that had PDUFA goal dates in 2016. These early approvals benefited patients by making the drugs available sooner, but also decreased the total of novel drugs approved in 2016. Another factor was the number of Complete Responses (CR), which describe deficiencies in the application, precluding approval, with advice on what the sponsor needs to do for FDA to support resubmission of the application. CDER issued 14 CR letters for novel drugs in 2016, higher than in recent years.”

Jenkins also notes that the primary deficiency in several of the applications was the failure to comply with FDA’s current Good Manufacturing Practice (cGMPs) regulation, whereas by comparison, only four of the 47 new drug applications issued a CR from 2010 through 2015 included a failure to comply with cGMPs as the primary deficiency.

FDA Process

For more background information, it is important to understand how the FDA approves drugs and biological products. As the FDA states, some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients.

Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.

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