It has been a nearly snow-less winter here in Washington, in contrast of course to last winter when I was housebound for nearly a week. Let me just say, I find neither of these extremes particularly desireable….
More importantly, here is a bit of what happened in our world this week that I thought interesting:
- CRL Issued for MannKind’s Affrezza – The FDA issued a Complete Response Letter this week for MannKind’s quest for approval for an inhaled insulin. According to the press release issued by the company, “[t]he principal issue raised by the FDA concerned the usage of in vitro performance data and clinical pharmacology data to bridge MannKind’s next-generation inhaler to the phase 3 trials conducted using its MedTone(R) inhaler. The FDA has requested that MannKind conduct two clinical trials with the next-generation inhaler (one in patients with type 1 diabetes and one in patients with type 2 diabetes), with at least one trial including a treatment group using the MedTone inhaler in order to obtain a head-to-head comparison of the data for the two devices. In the complete response letter, the FDA stated that after an adequate titration of study medication there should be at least twelve weeks of relatively stable insulin dosing at the end of the treatment period.” The company also conducted a Webcast on the matter. The announcement was significant not only because it serves as another milestone in the history of inhaled insulin, but also because it prompted calls for the FDA to reform the confidential manner in which FDA handles the issuance of a CRL.
- FDA Moves to Streamline Approval Path for Medical Devices – This week the agency announced that it would be putting into place a plan that contains 25 new actions that will be implemented during 2011 to improve the most common approval path for medical devices, commonly known as the 510(k) process. The centerpiece of the new system seems to be focused on a new “de novo” process for what the FDA terms as “innovative, low-risk” devices. In 2009, the GAO issued a report entitled “Shortcomings in FDA’s PreMarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments“.
- Two Consent Decrees in One Week – The FDA announced two separate consent decrees this week – one against a pharmaceutical manufacturer and one against a food manufacturer. The first was announced on January 18 involving Deltex, a contract manufacturer and distributor of prescription and over-the-counter (OTC) drug products. The government’s complaint, filed by the U.S. Department of Justice, detailed violations of the Federal Food, Drug, and Cosmetic Act involving manufacturing and distributing unapproved, adulterated, and misbranded drugs. Specifically, Deltex failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing OTC drug products, and failed to comply with current good manufacturing practice (cGMP) requirements. The second announced January 20 involving the Portland Shellfish Co. following a number of recalls over the past two years due to due to L. mono contamination.
That’s it for me this week. Have a good weekend everyone!