I am having a great deal of trouble wrapping my head around the fact that it is May, but look out the window and there it is. Inside the Beltway, we start counting down to the next Congressional recess, so that those guys get out of town, making less news, less trouble and less traffic. It was a very busy week here, and these are a few of the things I thought interesting:
- Lots of Testimony – The FDA was up on the Hill twice this week and the agency was really good about quickly posting the testimony to the Web site. First of all, yesterday Dr. Janet Woodcock delivered "Discussion Draft Of The ‘Food And Drug Administration Globalization Act’ Legislation: Drug Safety" before the House Committee on Energy and Commerce, Subcommittee on Health and the statement made by John Dingell extended gratitude that FDA appeared to be getting specific about authorities and needs. A few days before, Dr. Woodcock was again delivering testimony, this time before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations – this time on the Heparin issue. Perhaps Dr. von Eschenbach is seeking to leverage her credibility in the Congressional venue, which isn’t a bad thought, but it does cede authority over very important matters to someone who is not in charge of the agency, only one division.
- Consent Decree Signed – Ouch. Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc. According to the press release by FDA, FDA inspections conducted in October 2006 and January 2008 revealed cGMP deficiencies, including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions. These deficiencies do not necessarily mean that the defibrillators currently on the market will harm patients, but FDA is requiring corrections to ensure the continued availability of safe, effective, and reliable products. Note that previous FDA inspections in 2000, 2003 and 2005 showed similar violations. FDA issued warning letters after the 2000 and 2005 inspections, citing the cGMP violations.If you are interested, harken back to my earlier posting called Anatomy of a Consent Decree.
- Approvable Letter Issued to Discover Labs – The company announced today that it received an approvable letter last evening from the FDA for Surfaxin (lucinactant), an investigational treatment for premature infants suffering from Respiratory Distress Syndrome. The tone of the company’s press release seems to convey surprise at the action. The stock (DSCO) closed at $2.90 yesterday and this morning as of this writing has lost almost half its value, trading around $1.49.
That’s it for me this week. I’m off for a weekend of gardening, bike riding and raw oyster eating.
