Quite a week here inside the Beltway. It has become quite crowded with people running for President instead of people running government. Something like 10% of the Senate is in! That has to be a record. The real joke here is that people don’t really like Senators. During the 20th Century, only two Senators were elected to the presidency. One was Warren Harding, often regarded as a severely lackluster administration, and the other was John F. Kennedy, who barely won. You would think these guys and gals would get the hint.
But more particular to our interests, here is what happened this week involving FDA.
- Approvable Letter for New formulation of FazaClo® (clozapine) – In what has been a spate of announcements of approvable letters from the FDA, Avanir Pharmaceuticals announced an approvable letter in a press release issued January 30. The company stated that "the FDA identified two types of chemistry, manufacturing and control (CMC) data that need to be provided: updated stability data and disintegration specifications." The drug, currently approved, is seeking a new formulation. The drug is an orally disintegrating form of clozapine, indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard schizophrenic drug treatments and for reducing the risk of suicidal behavior in patients with schizophrenic or schizoaffective disorder.
- Dr. von Eschenbach speaks! – On the PBS NewsHour, Dr. von Eschenbach was interviewed on the new announcement by FDA on drug safety oversight. During the interview he spoke of an effort at transparency and communication on the risks that are discovered but shed no light on how that communication will take place without instilling undue alarm about a drug 18 month after its approval. He did say that the program will begin in March.
- VA and FDA to Share Drug Safety Data - The FDA issued a press release stating that the Veteran’s Administration and the FDA were going to begin sharing data. The agencies signed a memorandum of understanding (MOU) to share information and expertise related to the review and use of FDA-regulated drugs, biologics and medical devices (medical products). This partnership is part of the ongoing drug and medical product safety initiatives detailed in a report released today by the FDA. This is perhaps most noteworthy because one would have assumed that this was going on all along.
Have a good weekend everyone!