It is apparently May. Hard to believe. It is that time of year when one day you have the furnace on because it is so chilly and the herbs you just planted on the last warm day are threatened with frost, and then two days later, you flip on the air-conditioning because it is over 90 and the dog is panting. It is good to have variety in life. c
And here is some of the variety from the week I thought I’d share in the Weekly Roundup.
- Commissioner Speaks at FDLI, OPDP Does Not – Commissioner Gottlieb delivered the key note address at the Food and Drug Law Institute Conference held this week in Washington. While leading with reference to upcoming action on opioids and prescribing, in a move that got a lot of attention, he then focused on drug pricing, referencing the upcoming (and postponed) presidential speech on the topic. While pricing is not normally considered FDA subject matter jurisdiction, he referenced taking on the system of rebates between payers and manufacturers directly by having the federal government reexamine the current safe harbor for drug rebates under the Anti-Kickback Statute and he stated that “the framework the Secretary (Azar) has developed will dismantle many of the provisions that shield parts of the drug industry from more vigorous competition. This perhaps signals that the presidential speech on the topic will be substantive, or at least we are to anticipate it as such. On an unrelated note, the Office of Prescription Drug Promotion (OPDP) which has traditionally given an overview of enforcement was not a presenter on the agenda for the conference. OPDP has issued only a single regulatory action letter so far this year.
- FDA/FTC Action on e-Liquids to Kids – I had to look up the term “e-Liquid”. This week FDA and FTC announced that the agencies jointly sent Warning Letters to 13 manufacturers for packaging e-liquid products – the stuff that goes into e-cigarettes and contains nicotine – to resemble products that are healthy for kids, such as apple juice boxes and other packaging that would resemble products desirable for young people. In addition for deceptive marketing, the agencies cited some of the manufacturers for selling the products to minors. In the letters the agencies directed the manufacturers to review the packaging and respond with corrective measures.
- FDA Kicks the Food Can Down the Road – The agency published a notice in the Federal Register announcing that it was going to delay new food labels for another 1.5 years. Despite the fact that the final rule was published in May 2016, FDA has stated that manufacturers need more time to consider technical aspects. In an “FDA in brief” issued by the agency, Commissioner Gottlieb stated that “It’s crucial that we provide clear expectations so that industry can meet them. It’s just as important for consumers to be able to effectively use the updated food labels, and we’re launching a major educational campaign for consumers to help them understand the new nutrition information that they’ll be seeing in the marketplace.” No mention in the brief as to the nature of the technical aspects that required the extra time.
Things to Keep an Eye on This Week
- May 8 – House Energy and Commerce Committee Hearing – Combating the Opioid Epidemic: Examining Concerns About Distribution and Diversion
- May 9 – Public Workshop – Tissue Agnostic Therapies: Regulatory Considerations for Orphan Designation
- May 10 – Advisory Committee – Endocrinologic and Metabolic Drugs Advisory Committee Meeting – NDA consideration for candidate compound with proposed indication of familial chylomicronemia syndrome.
- May 11 – Advisory Committee – Joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee with Pediatric Advisory Committee – discussion of drug development for children with achondroplasia.
Regulatory Developments in Pharma/Biotech/Devices
- Complete Response Letter Issued for proposed biosimilar rituximab
- First-in-class CAR-T therapy gets second FDA approval
- Bone graft in spinal surgery gets expanded indication
Photo by Lee Pigott on Unsplash