Federal regulators have hit a highly public reckoning for their policies to provide speedy approvals for prescription drugs, benefiting Big Pharma’s profits but not necessarily patients — notably women in serious need of help with a shame of the U.S. health care system: the nation’s dismal state with injuries and deaths to expectant moms and infants.
The federal Food and Drug Administration 11 years ago gave Covis Pharma an expedited review and approval to market its prescription drug Makena, which the maker promoted as a rare medication to prevent preterm births.
In exchange, the company was supposed to conduct broader, rigorous, and more detailed studies to prove definitively that Makena prevents moms from delivering before 37 weeks, which is a serious problem that affected 1 in 10 births in 2020 alone, the New York Times reported. The newspaper also noted that preterm births are a greater problem for black women: