It has been a tumultuous few weeks. Despite my best intentions, there were no intervening posts from the last Roundup to this and last week’s had to be skipped due to lack of time. But trust me, I’m working on it. The busy-ness just hasn’t let up and I have been on the run – so this week I will cover more than usual and go back a bit as well.
- E-Cigs and Kids – Well the big news this week as well as last involved FDA actions to stem the rising tide of use among teens. It began when last week the agency issued a press release and the Commissioner issued a statement, outlining regulatory steps that were being taken against both retailers and manufacturers. The agency said that it was the largest coordinated enforcement action taken in FDA’s history, missing more than 1,300 warning letters and fines to retailers involved in the illegal sale of e-cigarette products to minors. In addition, there were 12 letters issued to other online retailers who continued to market products that resembled kid-friendly food products. In an interview on the PBS News Hour, Dr. Gottlieb stated that in addition, FDA was taking action vis a vis the flavored products by having manufacturers submit documentation that these products provide a net public health benefit, and further that “all options were on the table. With e-cigarette use among teen skyrocketing, FDA also announced “The Real Cost” Youth E-Cigarette Prevention Campaign to educate youths that vaping is not a risk free activity.
- FDA Completes REMS Guidance for Opioids – The final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) was approved this week by FDA, including for the first time immediate-release opioid medicines used in the outpatient setting. The program requires that training be made available to health care providers – including nurses and pharmacists – who are involved in the management of patients with pain, though according to the release, there is no federal requirement that makes the training mandatory. Since 2012, education has been part of the REMS for extended release and long-acting products, but immediate-release opioids account for 90 percent of all opioid pain medications prescribed for outpatient use. The action expands the REMS coverage from 62 products to 347.
- FDA to Enhance Review of Low-Risk Medical Devices by Third Parties – The agency has taken many steps to facilitate the faster review of new products across the board, steps that have included enhanced review cycles, for example. And concentrating agency efforts on areas that present the greatest risk has been an on-going effort for some time. Last week FDA announced that it was going to put forth a framework to “better leverage reviews provided by experts in FDA-recognized third party review organizations” that would be equivalent in quality to FDA’s own type of review. The plan is for the agency to expend less time and effort on low-risk devices by accepting outside review for submissions that are eligible. FDA will review the recommendations of third parties and then make a final decision, but “generally will not review the submission itself.” The plan can be found here. The draft guidance can be found here. The news of the plan was released through an FDA in Brief notice.
Things to Keep an Eye on This Week
- September 25 – Senate HELP Committee Subcommittee on Primary Health and Retirement Security -Hearing – Health Care in Rural America: Examining Experiences and Cost
- September 27 – Senate HELP Committee Hearing – Reducing Health Care Costs: Improving Affordability Through Innovation
- September 27 – House Energy and Commerce Committee, Subcommirtee on Health Hearing – Better Data and Better Outcomes: Reducing Maternal Mortality in the U.S.
- September 27-28 – Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender (Dr. Gottlieb giving keynote)
Regulatory Developments in Pharma/Biotech and Devices
- FDA approves device for treatment of acute coronary artery perforations
- FDA approves new treatment for hairy cell leukemia
- NIH launches study to test combination antibody treatments in HIV
- FDA issues guidance on heparin containing devices and combination products