It is that time of year when the temperatures can range by 30 degrees from morning until afternoon. The pollen counts are high and already sudden storms appear on the horizon to dump a lot of rain and then move on as if nothing had happened. One marvels that the year is already one-quarter passed. Vacation plans are made for summer. Blooms are blossoming in rapidly growing numbers. Bugs are not yet out. Every so often, it is a good time to stop, look around and realize that life is good.
And here is a bit of what happened this week:
- FDA and Device Data from Outside the U.S. – Foreign clinical trials can be less expensive than those in the U.S. but circumstances around the conduct of those trials can vary. This week FDA announced a draft guidance related to devices called “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the U.S. and has opened a docket that is scheduled to close on July 20, 2015. The agency said that the guidance describes the special considerations when using data from outside the U.S. and while the draft does not describe new policy, but describes FDA’s existing approach to this issue.
- FDA Warns on BMPEA – This week the agency sent five Warning Letters (non-OPDP) to companies regarding products labeled as dietary supplements which contained the substance Beta-methylphenethylamine – also known as BMPEA. As the letter states, a dietary ingredient is a vitamin, mineral, herb or other botanical and BMPEA is not and therefore products containing it are misbranded if labeled as a dietary supplement. In addition, it was noted that BMPEA is not an approved food additive, nor is it included in substances with GRAS (generally recognized as safe) status. The list of warning letters can be found here and a specific example of one of the letters here. The sending of multiple letters by the agency could reasonably be interpreted as enunciating or illuminating a policy position.
- Acting FDA Chief Speaks – Just 14 days into his new role as the Acting Commissioner for FDA, taking the place of former Commissioner Margaret Hamburg, Dr. Stephen Ostroff spoke at the annual meeting of the Food and Drug Law Institute. He acknowledged the role of the former Commissioner in leaving the agency in a stronger position than when she assumed her office. His remarks were entirely focused on the accomplishments of the past year – the approval of 51 new molecular entities last year, including more orphan drugs than at any other time and 17 of which were “first in class”, and two-thirds of which were approved in the U.S. before anywhere else and noting that a large number of them occurred under one of the agency’s expedited programs for new therapies; citing the role of FDA in assisting families seeking access to promising investigational drugs; bolstering the role of women and minorities in clinical trials, and several other achievements.
That’s it for me this week. Have a pleasant weekend. Enjoy.