STAT+: Pharmalittle: Pharma wins changes in bill concerning accelerated approval; pharmacy chains restrict purchases of pediatric pain relievers
Rise and shine, everyone, another busy day is on the way. And we can tell because, already, the Pharmalot campus is buzzing. The official mascot is bounding about the grounds in search of creatures, and our shortest short person is readying plans for the day. As for us, we are busy with the usual tasks, namely firing up the coffee kettle to make cups of stimulation. Our choice today is Vermont maple walnut. As always, you are invited to join us. Meanwhile, here are a few tidbits to get you started. We hope you have a smashing day and conquer the world. And of course, do keep in touch. …
Provisions opposed by industry were dropped from a bill that makes it easier for the U.S. Food and Drug Administration to withdraw drugs that were approved under an accelerated timeline, according to STAT. Gone from the bill is a requirement that companies enroll clinical trials by the time of accelerated approvals. Lawmakers also stripped a requirement that product labels disclose that medicines have been approved using the accelerated approval pathway. The industry did lose a measure that would have explicitly stated that drug companies may use data from medical claims and insurance data to help confirm that drugs work in post-marketing studies.
Continue to STAT+ to read the full story…
