FDA rush to meet drug approval deadlines doubles adverse patient effects, study finds

More drugs are approved in December than any other month, but end-of-year approvals are associated with twice the number of adverse effects, including hospitalizations and deaths, according to a study cited by The Wall Street Journal

The study, conducted by researchers at Harvard Business School, MIT and the University of Texas at Dallas, looked at all new drug applications approved by the FDA between 1980 and 2016.

The Prescription Drug User Fee Act, passed in 1992, requires that each drug approval request be assigned a goal date for the FDA to complete its review. Standard drugs must be reviewed within 10 months, and priority drugs must be reviewed within six months. 

The study found that the surge in adverse effects is not driven by these explicit deadlines, leading researchers to think they are linked to self-imposed benchmarks, according to the Journal

An FDA spokesperson told the Journal that during the 1980s until 1992 when the drug fee act was passed, almost 40 percent of drug approvals took place in December. But since 1992, the number of approvals has been spread more evenly throughout the year. 

The FDA also told the Journal that now, only about 12 percent of approvals for new molecular entities — which are drugs that have never been previously approved in any form — take place in December.

The study cited by the Journal said that out of all drug approvals, 15 percent take place in December, an increase of about 80 percent relative to the average month.  

The researchers concluded that drugs approved at the end of the year should receive additional scrutiny, according to the Journal

Read the full article here

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