Apologies are in order for the interruption in the Weekly Roundup schedule and no postings the last few Fridays. It was partially inspired by the fact that it was a busy few weeks for me. Conversely it seemed not so much for FDA despite the issuance of a number of not-so-interesting statements so it seemed a good idea to forego a few Roundup postings. Things got more newsworthy this week though and hopefully makes up for it. Included are a few things from weeks gone by. Next week no posting for July 4, resuming the week thereafter.
- OPDP Issues 2nd Letter of the Year! Just when you think FDA’s OPDP is on permanent vacation, they surprise you. The office of the FDA in charge of promotional enforcement which used to issue dozens and dozens of letters to companies each year has eeked out its second for this year. This one was not a warning, but an untitled letter, and the subject was a video for a product that has a boxed warning on its label. Yet FDA found the video contained absolutely no risk information. The video depicted an interaction between a physician and a patient whereby the patient expressed a speedy and breezy use of the product, which FDA also maintained was not an outcome that was typical for patients who might use the product. You can see the letter here.
- FDA Issues Guidance Clarifying Economic Discussions with Payers – In my last posting I covered new FDA Guidance related to discussions about useful drug information not contained in the label, but nevertheless consistent with the label. A companion guidance also covers discussions with payers and formulary committees about economic information not contained in the label to support decision-making around reimbursement. The audiences for this information include both public and private sectors, formulary committees, drug information centers, technology assessment committees, pharmacy benefit managers, third party administrators and other multidisciplinary entities that make coverage decisions. For approved drugs the information imparted must pertain only to approved labeling. The guidance covers situations where manufacturers are providing healthcare economic information (HCEI) to providers about approved drug products, medical devices as well as unapproved products, and the guidance divides the discussion under those categories.
- FDA Approves First Medicine Derived from Marijuana – You would have to live under a rock not to have heard this news, but it is historically significant enough for a number of reasons to mention here. First, the newly approved drug, Epidiolex, a purified form of cannabidiol (CBD) and one of more than 80 active chemicals found in marijuana. The new approval, which lacks the THC component for achieving a “high”, is indicated to treat seizures as a result of Dravet Syndrome and Lennox Gestaut Syndrome (LGS). Both conditions affect children. It is the first approval for a drug to treat Dravet. Both conditions can have a dramatic impact on quality of life for those affected and their families. But significance is also derived from the fact that the source material – marijuana – has long been advocated as a potential source of medicine. The study for potential benefits has long been hampered by legal constraints and by dogma but FDA has provided guidance for the clinical study of botanicals. The approval was under Fast Track, Priority Review and the drug has Orphan Drug Status. You can see the FDA press release here, the statement by the Commissioner on the importance of research in this area here and the company press release here.
- More on Patient Input – For a long time now we have heard about FDA transitioning to be more patient-centric, including the development and launch of a Patient Engagement Advisory Committee as well as holding a series of Patient Focused Drug Development meetings covering more than 20 disease areas. And in 2016, patient experience counted in the approval of a drug contrary to the recommendation of an FDA Advisory Committee. This week the agency issued a draft guidance document, the first of four planned, to explain to both patients and drug developers the principles by which FDA will incorporate patient and caregiver experience into the regulatory process. This particular guidance – Patient-Focused Drug Development: Collecting Comprehensive and Representative Input – concentrates on providing methodologies for how to operationalize the collection and use of patient experience data by drug developers.
Things to Keep an Eye on This Week
- July 11 – FDA Public Workshop – Development of Treatments for Localized Prostate Cancer
- July 12 – Antimicrobial Drugs Products Advisory Committee – Meeting to consider NDA for prevention of malaria relapse
Regulatory Developments in Pharma/Biotech/Devices
- Split decision by FDA on candidate for two indications – one approved, not not
- FDA issues guidance document on development of Pre-Exposure Prophylaxis in HIV