We are shifting gears as we head into the year’s end, with two months to wrap everything up and we kick it off by ending Daylight Saving 2018 this weekend – so remember to set your clocks back (Fall Back) this weekend. In the meantime, it was a week of long days and travel for me, precluding some intervening postings. That said, several things happened on the FDA front and here are a few of them:
- FDA Approves New Opioid – If you wondered whether or not it would be possible for another opioid medicine to be approved in the current climate, today FDA provided an answer. In his statement regarding the approval of the AcelRx compound Dsuvia (sufentanil sublingual tablet 30 mcg) for the management of acute pain severe enough to require an opioid analgesic in adult patients in certified medically supervised healthcare settings, Commissioner Gottlieb stated that in balancing the needs of pain patients with the risk considerations of the category, it is important to consider whether “new opioids are sufficiently better than existing drugs to justify their addition to the market in the context of the current crisis of abuse.” He described the unique approach taken with this particular opioid – that it is restricted in its use to certified medically supervised health care settings such as hospitals and administered by a health care professional using a pre-filled, disposable, single-dose applicator delivering the dose under the tongue. He stated that in addition to weighing each drug application on the merits of the individual drug, that in the case of opioids, FDA will use its new authorities with regard to post-marketing decisions and to require unit dose packaging and dispensing systems. He also cited, but did not limit himself, to the consideration of key questions in evaluating a new entry to this market – here in paraphrased form – (1) does an additional opioid benefit public health due to its properties; (2) does it create aded risk of diversion or misuse or other concerns; and (3) is there differentiation that will benefit certain groups of patients? His statement is lengthy and worth the read.
- OPDP Issues 7th Letter of the Year – After spending most of the year in regulatory slumber, the Office of Prescription Drug Promotion (OPDP) seems to be using this last quarter to play catch-up. This one was a Warning Letter, the second of the year, and involved two products (one for the treatment of schizophrenia and one for sleep/wake disorder) but only one communications vehicle – a web page. Earlier this year, the head of CDER, Dr. Janet Woodcock indicated that the agency would likely be reserving enforcement for violations that were the most egregious. What might that mean? In this case, it means a web page regarding a medicine that has a Boxed Warning, but which contained no risk information whatsoever. It its noteworthy that nearly all of the letters issued this year involved products with Boxed Warnings. The number of regulatory action letters for this year now surpasses last year’s low of five letters issued, but falls far short of the eleven from 2016. However in that year, OPDP issued six of them in the month of December – so given the recent spate of letters, let’s keep our eyes open. And if you are involved in communications for a product with a Boxed Warning, be alert.
- Recall of Test Strips to Monitor Blood Thinner Levels – It has not been a good year for cardio patients. First the recall of a major blood pressure medication and now a Class 1 recall announced for test strips used to monitor levels of warfarin in the blood stream for patients with blood clots at-home or in the doctor’s office. According to the FDA release there are millions of Americans who take warfarin to thin their blood, prescribed for patients who have certain types of irregular heartbeats, blood clots or who may have certain implant devices. FDA warned patients that they should not rely on the results of the tests from certain lots of the strips issued during 2018 and stated that use of the strips can result in serious errors in medication dosage as a result that could bring serious harm to patients using them. The agency stated that they are working with the company to ensure swift removal and replacement with corrected strips as soon as possible.
Things to Keep an Eye on This Week
- November 9 – Due Date for Response of Commissioner Gottlieb to Letter from Senators Warren, Murray and Smith
- November 8 – FDA Oncology Center of Excellence – Society for Immunotherapy of Cancer Public Workshop – Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials
Regulatory Developments in Pharma/Biotech/Devices/Food
- Findings from FDA Investigation into Romaine Lettuce E-Coli Outbreak
- FDA Issues Draft Guidance on Use of Dried Plasma Products in Transfusion
- FDA Permits Marketing of 2 Devices That Detect Parahyperthyroid Tissue Real Time During Surgery
Photo by Annie Spratt on Unsplash
