Yee Ha – Summer came at us this week and boy it was hot at the start! Summers in Washington have a few perks, however. Traffic is way down. Congress leaves town. The produce is great. And of course, like everyone else everywhere else, there are a host of delicious barbecues!
Here’s what happened during this hot week:
- Yet Another Approvable Letter – As noted in prior postings, there were a spate of approvable letters issued this week, including one company, Encysive, that received its third approvable letter on a single product. Then Shire and Pfizer were on the receiving end for an ADHD and HIV drug, respectively. Now Johnson & Johnson has received one for a 2 new supplemental applications for Risperdal, though it is reported that no new studies have been requested by FDA.
- More Issues with Tissues – Last week we reported that the FDA issued a report stating that there were no systemic problems in the human tissue industry. I pointed out that Alistair Cooke might differ, but apparently so does Congressman Frank Pallone, Jr. (D-NJ) who introduced legislation – H.R. 2731 – last Friday to bring reform to the tissue industry.
- PDUFA Legislation Moves – Legislation authorizing PDUFA IV moved forward, but without the provisions on DTC that sought to allow restrictions on advertising during the first three years. A very large amount of money will be reserved for activities surrounding post-marketing surveillance.
- FDA Approves First Drug for Treating Fibromyalgia – Lyrica (pregabalin) produced by Pfizer, is the first drug approved to treat fibromyalgia. Lyrica already has an indication for treating partial seizures, pain following the rash of shingles and pain associated with diabetes nerve damage (diabetic neuropathy).
That’s it for this week folks. Enjoy the beginning of summer.