
FDA Keeps New Drugs Coming
FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.
Despite major challenges and demands created by the coronavirus pandemic, FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19. Last year saw the Center for Drug Evaluation and Research (CDER) approve 50 new molecular entities (NMEs), many benefitting from priority and accelerated review timelines. In addition, the Center for Biologics Evaluation and Research (CBER) approved several vaccines and cellular products to further expand the new medicines list.
The CDER total is slightly less than the 53 novel drugs brought to market in 2020 and the 2018 record total of 59 innovative therapies. As in recent years,
Despite similar pressures,
Probably the most discussed new drug is Biogen’s Aduhelm for Alzheimer’s disease, which CDER okayed for market despite limited evidence of its efficacy and a thumbs-down on approval from its advisory committee. FDA reviewers, however, decided its benefits outweighed risks, as no other treatment is approved for this very serious condition.
Other notable new therapies from CDER include treatments for myasthenia gravis, lupus, Pompe disease, severe asthma, sickle cell disease, to prevent dwarfism in children, and to manage very high cholesterol. Lung cancer, endometrial cancer, and leukemia gained added treatment options, as did transplant patients.
The lists, moreover, do not include those innovative COVID-19 therapies and vaccines granted Emergency Use Authorizations (EUAs). In December 2021, FDA authorized two notable oral medications to treat early COVID-19 infections—Pfizer’s Paxlovid and Molnupiravir from Merck and Ridgeback Biotherapeutics—providing a more accessible alternative to antivirals that require infusion in a clinic or doctors’ office.
More inspection delays
Analysts note that several additional new products failed to gain approval in 2021 due to FDA’s inability to conduct necessary inspections of certain manufacturing sites. That situation is unlikely to change any time soon as the agency has once again pulled back on inspectional activities due to the spread of the omicron variant to COVID-19.
In July 2021, FDA revived efforts to ramp up inspections of domestic production facilities, an effort that made a notable dent in the agency’s sizeable inspection backlog for medical products. The hope was to visit most of the 3000 sites in need of oversight in 2022 and also to test a new program to enhance foreign inspection operations.
These goals were put on hold with the agency’s
Meanwhile, FDA will continue to utilize remote tools to maintain oversight of foods, drugs, medical products, and tobacco at home and abroad.
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About the author
Jill Wechsler is BioPharm International's Washington editor.
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