FDA not fit for purpose – the Makena® fiasco
For years, the FDA allowed a drug to be injected into pregnant women that was neither safe, nor effective. Finally, it has been withdrawn.
Previously, I wrote about Makena, a synthetic hormone given to millions of pregnant woman, to prevent premature birth. It was highly controversial because there was no robust proof that it was safe or effective, despite having FDA-approval.
Last month, after many years of use, the FDA finally decided to withdraw Makena from the market.
Adam Urato, a maternal-foetal medicine specialist at MetroWest Medical Centre, Massachusetts welcomed the decision, but said it took the FDA far too long.
“I cannot believe we’ve been injecting this hormone into pregnant women for 20 years, all the leading medical organisations recommended it, the FDA approved it - and it took this long to finally acknowledge the drug did not work,” he said.
Preterm birth is a major issue in obstetrics. In the US, one in 10 babies are born prematurely, and accounts for most of the neonatal morbidity and mortality.
Physicians were desperate for a solution, and Makena seemed to hold promise.
It wasn’t cheap though. Makena was 5,200% more expensive than generic versions of the same medication.
Large amounts of public money in the Medicaid program and other health insurance dollars were used to pay for the weekly shots at a total cost of $30,000 per pregnancy.
How it began
The FDA approved it anyway on the basis that the drugmaker conduct more in-depth research into the medication’s effectiveness.
Then, in 2019 a confirmatory trial found the drug did not work. And by this stage, there were documented harms including gestational diabetes, depression, blood clots and a non-statistical doubling in stillbirths.
But instead of pulling the drug off the market, the FDA allowed Makena to be licensed for another four years.
“It should’ve been pulled immediately,” said Urato. “There were substantial profits for the drug company even after a confirmatory trial found it did not work, so it’s no wonder it was dragging its feet.”