It has been a while since there has been a Weekly Roundup posting, primarily because FDA has been fairly quiet of late. In fact, during October the agency issued only 3 press releases and the same for November. Certainly lots is happening around the agency though, like the passage into law of the 21st Century Cures Act. This week we’ll have some things of note that the agency has done as well as a few updates on the changing environment.
- FDA Announces Eczema Approval – It has been a year short on drug approvals compared to last year, but FDA added one to the list for 2016 this week in approving Eucrisa, a phosphodeisterase 4 (PDE-4) inhibitor being indicated for the treatment of mild to moderate eczema in patients two years and older. According to the company press release, there has not been a new prescription available for patients in over ten years. While overactive PDE-4 has been shown to contribute to the condition, the specific mechanism of action is not known.
- FDA’s OPDP on the Move! – After a year that was relatively quiet on the enforcement front, Eye on FDA reported this week on two untitled letters issued by the Office of Prescription Drug Promotion (OPDP) related to DTC advertising and risk information. Then the following day a third and fourth letter was posted, this time both Warning Letters, also involving risk information (the most common violation cited in OPDP letters). This means OPDP has issued nearly as many letters so far this month as have been issued all year by that office.
- FDA and NIH Weigh In on Cures Act Passage - With the passage and signing into law of the 21st Century Cures Act, the heads of both FDA and NIH provided their perspectives in separate publications about the impact of the legislation on their respective agencies. FDA Commissioner Dr. Califf presented an FDA point of view in a blog posting on the agency blog – FDA Voice, while NIH leadership provided an in-depth discussion of the legislation in a Perspectives column in the New England Journal of Medicine.
That’s it for me this week. Have a good weekend everyone.