The legislation that would reauthorize the U.S. FDA’s user fee programs is now in the works in the House of Representatives, but the legislation is fairly lean when considering the number of issues facing the agency.
As the U.S. FDA transitions to another new commissioner, the number of approvals has dropped to the lowest levels in seven years and is 19% below those approved by this time last year.
The Senate Health, Education, Labor and Pensions (HELP) Committee met April 5 to review the user fee agreements for the drug and device centers, but one member of the committee was quite vocal about the ever-growing volume of user fees. Sen. Richard Burr (R-N.C.) said the pace with which user fees are increasing suggests that the FDA is growing increasingly independent of Congress.
Executives of Spero Therapeutics Inc. evaded analysts’ attempts to clarify “deficiencies” noted by the U.S. FDA in its ongoing review of the company’s NDA seeking approval of oral carbapenem antibiotic tebipenem HBr for complicated urinary tract infections (cUTIs), emphasizing instead that they have three months to work with the regulator ahead of a June 27 PDUFA date assigned to the application.
A total of seven new molecular entities (NME) have been approved by the U.S. FDA this year, while another seven therapies received dreaded complete response letters from the agency. Out of 9 FDA approvals in February, including two BLAs, three NDAs, three supplemental applications, and one abbreviated NDA, were three NME clearances.
Only three other years during the past three decades did the U.S. FDA approve more new molecular entities (NMEs) than the 50 cleared in 2021, a year that was plagued with numerous delayed decisions. There were 53 NME approvals in 1996 and 53 again in 2020. The record is held by 2018, which had 59 approvals.
In what is undeniably one of the busiest years for governmental agencies across the globe, 2021 churned out a 12% increase in regulatory news over the previous record year of 2020.
A busy regulatory environment globally throughout most of 2021 has translated into more than 15% of all actions taken relating to the COVID-19 pandemic, yet only one product has been approved in the U.S. for the SARS-CoV-2 virus.
With a 14% increase in regulatory news over this time last year, 2021 has proved to be the busiest that the biopharma industry has ever seen, as companies continue to seek clearances of their late-stage pipeline products with a backdrop of an unprecedented number of COVID-19 pandemic efforts.
While the volume of regulatory data is above this point last year by more than 17%, the proportion of COVID-19-related news is nearly the same, as is the number of U.S.-approved new molecular entities (NMEs).
