After a drug enters the market, it’s up to Food and Drug Administration regulators to ensure its continued safety and efficacy. A recent New York Times story suggests that, in the case of the popular asthma drug Singulair, the FDA fell short — both because the agency delayed action for years on reports from patient advocates and independent groups that the drug could cause suicidal thoughts, and because when it did add a warning label about its potential side effects in 2020, clinicians and patients still weren’t always aware of the risks.
Experts say that the Singulair incident highlights a flawed system, both in the U.S. and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address.
“The question is, how safe do you want to be?” said Ameet Sarpatwari, the assistant director of the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital. Ideally, he said, the FDA should be able to both stay on top of safety concerns and avoid unnecessarily restricting access to drugs. “Are we at the right balance? I think there are definitely situations for many drugs where you can say, no, we’re not really at the right balance, and the FDA should be taking a more aggressive stance in promoting patient safety.”