Another busy week that did not permit me time to get to some of the postings I have been working on between Roundups, but next week look for some. There has certainly been a lot going on and a lot to talk about. In the meantime, some of the many interesting things that occurred this week:
- Opioid Crisis Response Act of 2018 Moves Out of Committee – Upon a unanimous vote, the Senate HELP Committee advanced new legislation – the Opioid Crisis Response Act of 2018 – aimed at multiple aspects of the opioid crisis. The bill represents a culmination of several hearings on the topic, some of which directly involve FDA. Specifically the bill has built into it a number of clarifications to make clear that FDA has authority to require specific packaging for opioids (such as pill-limited blister packs, often a tool mentioned by Commissioner Gottlieb) to address over-prescribing; ability of the agency to require disposal programs by manufacturers as part of the packaging; and providing FDA and border patrol with greater detection equipment and technology to screen for illegal imports. On the drug development side, FDA would be tasked with facilitating development of non-opioid/non-addictive investigative compounds by navigating existing expedited approval pathways and to provide new guidance related to the risk-benefit assessment of products with a potential for misuse/abuse; on label claims respective to products on pain control and opioid reductino of use; and on appropriate use of endpoints in clinical trials for non-addictive and non-opioid pain treatments. This brief summary focuses on FDA, but there are also a number of provisions that address responsibilities of various stakeholders.
- Second Installment by Gottlieb on FDA Budget – Last week in remarks before the House Committee on Appropriations, Commissioner Gottlieb took a short victory lap around some FDA achievements and outlined some future moves related to smoking and nutrition and food labeling. This week on the other side of the Hill before the Senate Committee on Appropriations, he continued in the same vein, but with added content that had a dual focus. First he said the additional money being provided in the budget for FDA would go to modernizing the review process for generic drugs, improving on what was already a banner year in new generic approvals, with an aim to (among other things) bring the costs of drugs down through the increase in competition as a result. This will include a drive by FDA to bring drug labels of generics up to date where the original product on which label updates rely has been withdrawn. The second area of focus was to provide up to date information on the safety and efficacy of drugs in use on the market to help patients make informed decisions. The full text of remarks can be found here.
- FDA Takes Action on Multiple Fronts Against E-Cigs and Youth – FDA outlined a plan of action last year aimed at reducing the introduction of nicotine products to young people. Often plans remain just that, or their implementation is sketchy. This week FDA announced broad action on e-cigarettes focusing on both retailers and manufacturers. With respect to the former, the agency cited retailers for sales to young people and are seeking to address online sales. And on the manufacturing side, the agency is seeking information about marketing and related documents in a bid to discover what has made the products so popular among kids and the agency will also be looking for ways that companies have sought to mislead young consumers.
Things to Keep an Eye on This Week
- May 1 – Antimicrobial Drugs Advisory Committee – meeting to consider NDA for treatment of smallpox
- May 2 – Antimicrobial Drugs Advisory Committee – meeting to consider NDA for treatment of urinary tract infection
- May 3 – Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee – meeting to consider NDA for treatment of neonates greater or equal to 35 weeks of gestational age with indications of hemolysis at risk for development of severe hyperbilirubinemia
Regulatory Developments in Pharma/Biotech/Devices
- FDA Approves First-Line NSCLC drug
- IV Formulation Approved by FDA for Treatment of Chemo-Induced Nausea/Vomiting