Fall is in the air, election ads are on the air – it is definitely October, the time of trick or treat. Mums and pumpkins have replaced summer stock on front porches and in yards. Thanksgiving foods are on display in the grocery – lots of cinnamon, eggnog and cans of pumpkin. I even saw cranberries on display. And on the more official front, most certainly the biggest news of the week was the surprise activity in enforcement out of OPDP noted in yesterday’s posting which most certainly adds some more specific definition into the current approach which has been lacking for a long time.
Otherwise it was a bit slower on the FDA side of things. Even the FDA Commissioner only issued a single statement. In any case, here is a bit else of what happened:
- Commissioner Marks Progress and Issues New Draft Guidances – The one statement the Commissioner did issue this week was noteworthy in that he cited the progress that the agency has made in not only getting new products approved, but promoting targeted therapies. He noted that with two months still to go, FDA was only one drug shy of hitting last year’s record number of new approvals. The occasion for the statement was the issuance of two new guidance documents. The first was a draft guidance – Hematologic Malignancies: Regulatory Considerations for Minimal Residual Disease in Development of Drug and Biological Products for Treatment and the second a final guidance – Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease – which would be a fancy way of saying helping to find gene variants that cause disease in smaller groups of patients. The statement is noteworthy not only because of the number of drugs approved for this year heading to a record, but because it is part of a larger body of activity that would appear to be turning the giant ship that is known as FDA.
- FDA Provides Additional Contour to DTC and Product Labeling – In addition to the actions noted in yesterday’s posting regarding DTC and enforcement , there was some further contour to the issue of product labeling and product promotion provided in speech given this week by the FDA Chief of Staff before the Food and Drug Law Institute on October 16. In it, toward the end of the speech, she laid out some additional particulars on the studies that FDA will be conducting related to product promotion as well as the issuance of a new guidance – Presenting Quantitative Efficacy and Risk Information in DTC Promotional Labeling and Advertisements – designed to help better translate the sometimes complex results from clinical trials into something that is meaningful and understandable by patients and consumers. The draft guidance provides concrete examples and given the fact that the conveyance of risk information is the most frequent violation cited by the Office of Prescription Drug Promotion in regulatory action letters issued, those who are involved in communications promoting medicines should take a look carefully. The draft covers several promotional mediums – print, electronic, audiovisual and broadcast.
Things to Keep an Eye on This Week
- October 22 – FDA Science Advisory Board Meeting – CVM’s Antibiotic Resistance Monitoring System
- October 23 – FDA Workshop – Data Integrity in Global Clinical Trials – Are We There Yet?
Regulatory Developments in Pharma/Biotech/Devices/Food
- FDA takes steps to improve mammography quality
- FDA issues draft guidance on premarket submissions on cybersecurity in devices
- Administration announces “Winning on Reducing Food Waste” initiative