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# CDER Dismisses 26% Drop in 2022 Drug Approvals
- URL: https://www.fdaweb.com/cder-dismisses-26-drop-in-2022-drug-approvals/
- Published: 2023-01-09T12:00:00.000Z
- Updated: 2026-09-14T18:11:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153492

While CDER novel drug approvals fell 26% last year to 37 NDAs/BLAs getting the green light, the Center is not worried that this may signal any slowing workload trend at the agency. The 37 approvals are the lowest since 2016 when 22 approval were tallied (see *Nature* [article](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=newssearch&cd=&cad=rja&uact=8&ved=2ahUKEwjZmPGxkLv8AhWGKlkFHchCArYQxfQBKAB6BAgHEAE&url=https%3A%2F%2Fwww.nature.com%2Farticles%2Fd41573-023-00001-3&usg=AOvVaw2fkK2eQez5oUqLVLOyUVfS) on annual approval totals dating back to 1993).

Historically, FDA has dismissed drawing any conclusion from annual drug approval numbers, and this year is not different. Officials in the past have noted that the agency can only review applications that are submitted. “The number of drug applications CDER received in 2022 was similar to the previous few years,” a CDER spokesman told ***FDA Webview*** 1/6\. “However, because each application is unique and considered individually, the number of approvals and complete response actions will fluctuate year-to-year, so it is difficult to compare the total number of approvals year-to-year and draw any meaningful conclusions about differences.”

In addition to notable drug approvals in 2022 (again, see *Nature* article above), 2022 saw a continued expansion of “regulatory flexibility.” CDER Office of Neuroscience and its director **Billy Dunn** continued to push the envelope after exercising flexibility in 2021 with their controversial accelerated approval of Biogen’s [Aduhelm](https://www.fdaweb.com/uproar-greets-fdas-aduhelm-ok-for-alzheimers/) after an advisory committee unanimously shot down a recommendation for traditional approval. The expanded flexibility could be seen in the office’s decision to hold a second advisory committee after Amylyx submitted additional data for its Lou Gehrig’s drug Relyvrio ([see earlier story](https://www.fdaweb.com/2nd-time-a-charm-in-als-drug-panel-vote/)).

While Dunn acknowledged that existing clinical trial data may not satisfy the agency’s typical requirements, he heavily emphasized FDA’s regulatory flexibility, and publicly asked Amylyx during the second advisory committee that if the agency were to approve Relyvrio, would it agree to voluntarily withdraw the drug if ongoing confirmatory trials fail to demonstrate a clinical benefit.

“In a case that falls in between FDA’s legal authority under its accelerated approval pathway and its more traditional ‘substantial evidence’ standards, Dr. Dunn has demonstrated a willingness to use nontraditional strategies to push the boundaries of FDA’s regulatory flexibility,” a 1/9 *Health Affairs* [article](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=newssearch&cd=&cad=rja&uact=8&ved=2ahUKEwi50ZrAkbv8AhXcMlkFHT7BAUkQxfQBKAB6BAgIEAE&url=https%3A%2F%2Fwww.healthaffairs.org%2Fdo%2F10.1377%2Fforefront.20230109.658950&usg=AOvVaw1neFj8q408Up5IXX1wy31z) points out. “To the extent that Dr. Dunn continues to do so, his decisions may have ramifications for public trust, payer coverage, and the level of evidence patients and clinicians have as they make important treatment decisions.”

Approvals in 2023 and beyond are likely to be shaped by the 9/2022-signed five-year reauthorization of the [Prescription Drug User Fee Act](https://www.fda.gov/news-events/congressional-testimony/fda-user-fee-reauthorization-ensuring-safe-and-effective-drugs-and-biologics-02032022?ref=fdaweb.com), and FDA reforms that were included in the recent omnibus bill ([see earlier story](https://www.fdaweb.com/fda-reforms-included-in-year-end-omnibus-bill/)).