STAT+: Pharmalittle: U.S. lawmaker proposes bill to curtail FDA’s accelerated approval; Moderna to enforce Covid patents in wealthy countries
Top of the morning to you. A shiny sun is enveloping the Pharmalot campus this morning, although a blustery March wind is making for a rather cold, wintry climate. Nonetheless, we are keeping warm by quaffing several cups of stimulation — our choice today is salted caramel mocha. And why not? After all, no prescription is required. Perhaps, you may want to embrace the same strategy. While you consider the possibilities, here are some tidbits to start the day. Hope you conquer the world today, and do stay in touch. …
A powerful Democratic lawmaker introduced a bill that would dramatically rein in the U.S. Food and Drug Administration’s accelerated approval program, STAT writes. Under accelerated approval, the FDA can approve drugs without clear evidence that they actually prolong patient lives, so long as drug companies complete follow-up studies and demonstrate that the therapies actually do have a “clinical benefit.” The bill, which was introduced by the chairman of a key health committee, Rep. Frank Pallone (D-N.J.), would make it easier for the FDA to crack down on drug companies that do not complete those follow-up studies.
Continue to STAT+ to read the full story…
