CAMLAW: Complementary and Alternative Medicine Law Blog

FDA Accelerates Approval for Certain Generic Drugs

The Food and Drug Administration will accelerate its reviews of certain generic drugs.

Reuters reports that "Companies will be given priority if their application is the first one proposing a generic version of a brand-name drug that is no longer protected by a patent or market exclusivity, said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. Applications filed before a patent or exclusivity ends will not be eligible under the new procedures, which have already been implemented....Generic medicines that would address a public health emergency or nationwide shortage will also see faster reviews, he said."

That's good news, since it can take up to ten years and upwards of $10 million to get new drug approval. This is the major reason dietary supplement manufacturers benefit from the DSHEA, which essentially provides that dietary supplements, when properly labeled, need not go through FDA approval for safety and efficacy prior to entering the market.

Generic drugs also open the market and access to medicine by providing less expensive alternatives to consumers than branded drugs.

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Michael H. Cohen, Esq.; 468 North Camden Dr. | Beverly Hills, California 90210 | 310-844-3173