The calendar says that it will be Spring next week, but it did not feel like it to me while working in the cold, windy and rainy garden in the days leading up to this change in season. However, it has been an interesting week on a number of fronts and here are a few things that I thought we should recap as we close out the week.
- A Survey of Professional Prescription Drug Promotion – As part of its ongoing study of promotional efforts, FDA has surveyed healthcare professionals about their opinions related to DTC and promotions aimed at patients. This week FDA announced that it would be conducting a survey of health care professionals to examine issues related to promotional efforts aimed at them specifically given that many health care professionals (HCPs) rely on such information to further their understanding of a particular treatment category and that industry has a wide variety of communications vehicles they employ in that regard. FDA wants to see how HCPs might be influenced in their decisions and practices by promotional materials. Of note, Dr. Gottlieb said in a tweet about the survey that it would include questions specific to opioid products and knowledge about abuse deterrent formulations, regarded by the agency as critical to the agency’s work in countering the opioid abuse and misuse crisis.
- Right to Try Fails – The legislation popularly known as “right to try” which was endorsed by the President in the State of the Union message and which has had the enthusiastic support of the Vice President and which has passed in the Senate failed to garner enough votes in the House of Representatives this week. Brought to a vote through a procedure that fast tracked the bill but which required a two-thirds majority, the legislation lacked the votes for passage. The object of the legislation is to give patients greater access to unapproved medications under particular circumstances, but which many argued would give a dangerous bypass of FDA and it was opposed by many patient groups and professionals who you might think would have favored it. In fact, over 70 of them submitted a letter to Congress in opposition. . However, given this is an elected body that made several dozen fruitless resurrected attempts at repealing the Affordable Care Act, it is entirely likely that this issue will be revisited and under circumstances that may be more amenable to eventual passage.
- Move to Make Smoking Less Addictive – FDA announced this week that it was issuing an advance notice of proposed rule making (ANPRM) to consider approaches to lowering nicotine levels in cigarettes to minimally or non-addictive levels. The agency is seeking input into process, particularly around questions as to the appropriate maximum level of nicotine that should be present and whether or not new standards should be gradually lowered or not and to identify any potential unintended consequences that may result. FDA anticipates that the lowering of nicotine levels in cigarettes has the potential to help millions of people quit smoking within a short period of time. You can see an overview of the full scope and range of efforts FDA is taking on this issue in reading the Commissioner’s statement located here.
That’s it for me this week folks. Have a good weekend – the last of Winter.
Upcoming Events to Keep an Eye on This Week
- House Energy and Commerce Committee – Oversight and Investigations – The Drug Enforcement Administration’s Role in Combating the Opioid Epidemic – March 20, 2018
- Blood Products Advisory Committee Meeting – Discussing reclassification from Class III to Class II of diagnostic devices used in HIV and HCV – March 21, 22
- Pediatric Advisory Committee Joint Meeting with Endocrinologic and Metabolic Drugs Advisory Committee – Discussing Phase 3 Development Program for treatment of children achondroplasia – March 22
Regulatory Developments in Pharma/Biotech/Devices
- Breakthrough Status for another pembrolizumab indication
- Breakthrough Status for a cystic fibrosis candidate
- Breakthrough Status for erdafitinib for metastatic urothelial cancer