The FDA’s Center for Drug Evaluation and Research approved 37 new drugs in 2022

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved 37 new drugs in 2022, the agency said in a report released Tuesday afternoon.

More than half of the newly approved drugs were for patients with rare diseases, the CDER said, highlighting new treatment options for acid sphingomyelinase deficiency, generalized pustular psoriasis and hypertrophic obstructive cardiomyopathy, among others.

The agency said it met or exceeded the prescription drug use fee goal for 97 percent of new drugs it approved, and issued new approvals 76 percent of the time during the first cycle.

Additionally, 68% of new approvals occurred in the United States before being approved in other countries, while 65% used one or more expedited programs for serious conditions. The CDER also approved the 40th biosimilar in 2022 and two interchangeable biosimilars.

Patrizia Cavazzoni, MD, director of the CDER, wrote in a blog post accompanying the report that the number of new approvals in 2022 mirrored that seen in past years, indicating that “innovation remains strong in the drug development sector.” .

“The decision to approve a therapy involves a multidisciplinary team of experts from across the CDER carefully reviewing drug applications and calculating the benefit-risk ratio. I am grateful to my colleagues at CDER for their expertise, dedication and collaboration in the medicines review process,” Cavazzoni wrote. “The medicines we approved in 2022 will improve the lives of patients and consumers and I look forward to come another productive year in 2023”.

While the approval of more than three dozen new drugs holds promise for patients and providers facing complicated diseases, the pricing of these drugs remains a significant concern.

The median annual price of new drugs approved by the FDA in 2022 was $222,003, according to a recent analysis by Reuters, well above the $180,000 median annual price for new drugs marketed through mid-2021.

Some hope the recently passed Inflation Reduction Act will give the Department of Health and Human Services the ability to negotiate lower drug prices on behalf of patients.

However, HHS can only negotiate prices for drugs that have been on the market for years without generics or competition, so there is speculation about what drug companies will do in relation to introductory price fixing on new drugs.

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