FDA Announces Record Number of Generic Drug Approvals



The U.S. Food and Drug Administration (FDA) announced that its efforts to increase drug competition via generic drugs had resulted in a record number of generic drug approvals this year. For fiscal year 2019, the agency reported 1,171 generic drug approvals, 935 of them full approvals and 236 tentative approvals. This is up from last year’s all-time record of 971 generic drug approvals.

The announcement comes only a day after it was reported that Teva Pharmaceuticals is discontinuing manufacture of its generic version of vincristine, a chemotherapy drug vital to the treatment of childhood cancers, including leukemias, lymphomas and brain tumors. In this case, Pfizer manufactures the only branded version of the chemotherapy agent, which has physicians worried this will result in shortages.

The Center for Biosimilars noted, “Such care interruptions have become more common, due to shortages of older, off-patent drugs and insufficient generic competition. Besides creating patient care issues, the shortages also limit potential cost savings.”

The FDA and federal government have encouraged the utilization of generic drugs to create direct cost-savings for consumers as well as to drive competition that should result in lower prices overall. The agency indicated that generic drugs account for about 90% of all prescription drug purchases in the U.S. and that last year the competition from generics saved the health care system approximately $293 billion.

In the announcement, Acting FDA Commissioner Ned Sharpless said, “Thanks to the FDA’s ongoing efforts under the Drug Competition Action Plan and the Generic Drug User Fee Amendments, the FDA has built a thriving generic drug program that continues to impress me. I am pleased to report that our generic drug program is having another strong year. While we expect to see highs and lows in our approval numbers from month to month based in part on what is submitted to us for assessment, I’m delighted to share that our fiscal year 2019 figures overall show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals).”

Sharpless went on to note that it wasn’t enough to just bring the generic drugs to market, but consumers need to be confident in the safety and quality of the generics. “The FDA’s scientific review and assessment process for generic drug applications ensures that generic medications perform the same way in the human body, have the same active ingredients and have the same conditions of use as their counterpart name-brand medication.”

Interestingly, of the 1,181 approvals, 125 were for first-time generics for drugs, meaning there was no previous generic competition. One of those was an emergency opioid overdose treatment, as well as drugs for pulmonary arterial hypertension (PAH), breast cancer, seizures, depression, and infectious diseases.

Researchers from Yale University recently published research in JAMA Network that characterized generic drug approvals during generic drug shortages. Part of the goal was to determine if the FDA’s actions to improve generic competition had any impact on generic drug shortages. The overall conclusions were that it was too early to tell.

The FDA policy defines competition as two or fewer versus three or more existing manufacturers of a generic drug at the time of approval, wrote The Center for Biosimilars. “A prior drug shortage is defined as any drug shortage lasting one month or longer for the same active ingredient and dosage from within five years prior to approval.”

The study authors concluded, “Although our results suggest that there have not yet been noticeable effects of the FDA’s initiatives to expand approvals for generic drugs at risk for price spikes and shortages, ANDAs [Abbreviated New Drug Application] take time for the manufacturer to prepare and then another six to 12 months for regulatory review. Nevertheless, continued attention is needed to foster approval of generic drugs with limited competition and prior shortage.”


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