End-of-year US drug approvals tied to more adverse events – study

Results from a new study showed that drugs approved near the end of the year in the U.S. are linked to more hospitalizations, life-threatening events and deaths, a rate about twice as high as medicines approved earlier in the year.

Investigators also found similar bumps at the end of each month, implying that the reviewers are “clearing their desks” at these timepoints. They found that 15% of all new drugs were OK’d in December, a rate 80% higher than the average month, although the FDA says only 12% of new molecular entities are approved in that month.

in the 1980s and 1990s, 40% of U.S. approvals occurred in December but the trend is more evenly distributed since PDUFA was approved in 1992.

Selected tickers: BIB, THW, ARKG, BME, GRX, IXJ, BIS, CHNA, XLV, IDNA, GDNA, KMED, XBI, BMY, PFE, OTCQX:RHHBY, MRK, LLY, ABBV, JNJ, AMGN, BIIB, GILD, GSK, AZN, MYL, BHC, TEVA

https://seekingalpha.com/news/3529476-end-of-year-drug-approvals-in-u-s-associated-adverse-events-study