This has been a rather extraordinary year from an FDA perspective. Last year there were record approvals and a number of firsts. Advances in oncology have been eye opening to say the least. And on a policy front, there has been an aggressive push by a new Commissioner to broadly advance change. There is lots going on.
On a more personal front, the sod is unfurled, the pansies are planted and so have a good deal of the herbs. And yet Yankee Opening Day was called for snow. It is a season where anything can happen. Snow was predicted for Saturday – 5-8 inches -100 percent chance – a prediction now morphed to a slight rain shower possibility. Certainly a time to be on one’s toes.
And here is a bit of what happened this week.
- Gottlieb Speech on Opioids – The Commissioner delivered a speech this week to the National RX Drug Abuse and Heroin Summit in Atlanta this week that made headlines with regard to his call for greater effort on the part of social media platforms and internet service providers in identifying and removing listings that offer illegal purchase of opioids. While certainly noteworthy – one of those obvious questions no one seems to ask – it nevertheless was not the only important point of the speech. He also called for a uniform system for electronic prescriptions for controlled substances as well as evidence based dosing instructions to add a layer of rationality in prescribing, citing the fact that treatment of acute pain practices now vary widely. Given not only the magnitude of the issue, but the focus of the Commissioner on the subject matter, one is advised to reach beyond the headlines and review the entire speech. That said, do not be surprised if the Internet and social media question do not come up again.
- NIH Pan-Cancer Atlas – Speaking of advancements in cancer treatment over the past few years, the National Institutes of Health announced this week that it had completed an in-depth genomic analysis and compiled a data set that provides a data set of molecular and clinical information from over 10,000 tumors representing 33 different cancers. According to NIH Director Dr. Francis S. Collins, the Atlas will provide information that will serve to enable better informed clinical trials in the future and the papers that comprise it can be found on cell.com and the decade long effort will be capped by a symposium to be held in Washington in September.
- FDA Issues First Ever Mandatory Food Recall – On February 21, FDA issued a voluntary recall for products containing the supplement kratom, overseeing the destruction kratom products, because of concerns related to opioid properties the agency said were present in the supplement as well as reports of salmonella associated with its use. This week the agency stepped up its actions when it issued a mandatory recall – the first ever issued by FDA – because the agency said one particular company – Triangle Pharmanaturals – had not complied with the voluntary recall and that salmonella was found to be present in the products. While FDA has expressed concern about the use of kratom by consumers – used by many for relief of pain or symptoms associated with opioid withdrawal – the Commissioner stated in the FDA press release that the agency was making the move based on the public health threat posed by the presence of salmonella. Following the action by FDA, the company’s Website no longer was functioning and its Facebook page was taken down.
Things to Keep an Eye on This Week
- April 11 – Senate HELP Committee Hearing – The Opioid Crisis Response Act
- No advisory meetings scheduled
Regulatory Developments in Pharma/Biotech/Devices
- Refuse to File from FDA for Depression Treatment Candidate
- FDA Accepts BLA and Grants Priority Review for Hairy Cell Leukemia Candidate
- FDA Fast Tracks Non-Small Cell Lung Cancer Application