regulation
How concerned should biotech be about Prasad?
While the tone of Prasad's remarks at the FDA was calm, the response on Wall Street to news of his appointment, as discussed in yesterday's newsletter, was anything but. Biotech stocks plunged.
How much should the industry really be concerned, though?
He'll no doubt be tougher regulator of gene therapies than his predecessor Peter Marks, my colleague Adam Feuerstein writes. But in the long run, requiring stringent trials and strong evidence will lead to better drugs that benefit both patients and companies, in this view.
It's probably also unlikely Prasad will be so strict that companies abandon the field, given that FDA Commissioner Marty Makary chose him, and Makary has been advocating for streamlining and accelerating reviews of rare-disease drugs, Adam writes.
Read more.
GLP-1s
Judge deals blow to compounding pharmacies
Compounding pharmacies suffered another blow yesterday, as a federal judge sided with the FDA over its decision last year to remove Eli Lilly's GLP-1 drug tirzepatide (branded as Mounjaro and Zepbound) from its shortage list.
When GLP-1 drugs were in shortage the last two years, hordes of compounders began making cheaper copies, but when the FDA removed tirzepatide from its shortage list at the end of last year, that meant compounders could no longer keep making copies. A compounding trade group sued the FDA, arguing that the branded drug was in fact still in shortage, but the judge has now ultimately ruled against the group.
The same judge last month also rejected a bid by the same trade group to allow compounders to continue making copies of Novo Nordisk's semaglutide (branded as Ozempic and Wegovy). That case is still playing out, though, as the judge hasn't yet issued a final ruling.
Read more from STAT's Ed Silverman.
These developments have left many patients who rely on compounded drugs in a near-impossible situation. The telehealth companies and pharmacies that offer compounded products are now pursuing potentially risky strategies like mixing in additives or encouraging patients to stockpile. At the same time, many patients still can't afford the branded treatments. Read more on cases like this here.
