Happy Friday the 13th, one of two for this year. Don’t worry, the other one happened already in April. I have been out on vacay for a bit, along with many I think. But back at the grind now and have some stuff coming up for you next week looking back at the first six months of FDA activity from a few perspectives. Congress is back from vacay as well, so things are on the upswing here in D.C., at least for a while. Here is a bit of what happened this week.

• OPDP is on a Roll!  Talk about vacations – after a long dormancy, this week FDA’s Office of Prescription Drug Promotion (OPDP) issued its third regulatory action letter this year, and the second for June. Like many others in the recent past, this one was for promotion of an unapproved drug.  That means that 8 of the last 18 regulatory action letters issued by OPDP were issued about this violation, indicating that it is an area that will still move OPDP to act. The communications vehicles in question were an exhibit booth and a website. The compound is being studied for use in treating AML, but FDA said that the communications involved statements and presentations that made conclusions about safety and efficacy, using language to represent that the drug has a role in the treatment of AML.  This letter was an untitled letter, as were the other two for this year – so far no Warning Letters. But just a reminder from OPDP, low enforcement does not mean no enforcement.

• Gene Therapy Gets Guidance – A lot of it, in fact. FDA issued three new draft guidance documents and in addition issued updates to three existing draft guidance documents. The new ones related to the development of therapies in condition-specific circumstances. There was one for product development for hemophilia, for retinal disorders, and one for rare disorders. And because the field has seen rapid advance, those with new updates include Chemistry, Manufacturing, and Control (CMC) for Human Gene Therapy Investigational NDAs, Testing of Retroviral Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up, and Long Term Follow-up After Administration of Human Gene Therapy Products. In the past twelve months, FDA has approved three new gene therapies. You can read the Commissioners lengthy statement on the guidance documents here, and you can review and submit comments to the docket on any of them here. 

• Balancing Access to Pain Meds with Addressing Abuse – The line is not entirely clear. FDA has taken some meaningful actions to address abuse potential and some that might be considered questionable. This week there was an effort to provide an update and some context when the Commissioner issued a statement regarding access for patients in need of pain control with the need to take steps to stem abuse. While mentioning that FDA was holding a meeting with patients experiencing chronic pain in one of the agency’s Patient Focused Drug Development meetings and looking ways to innovate the development of devices that may treat pain, little was said in this statement about actual efforts being taken now to assure access for legitimate patients while a good deal of it was focused on avenues to misuse. In the end, to this reader, there was a lack in balance in the statement itself, much less the approach being taken. 

Things to Keep an Eye on This Week

• July 17 – Senate HELP Committee Hearing – How to Reduce Health Care Costs: Eliminating Excess Health Care Spending and Improving Quality and Value for Patients
• July 17 – House Energy and Commerce Oversights and Investigations Subcommittee Hearing – Examining State Efforts to Improve Transparency of Health Care Costs for Consumers

Regulatory Developments in Pharma/Biotech/Devices

• FDA Forms Drug Shortages Task Force
• FDA Investigates Canine Heart Disease Potentially Linked to Diet
• FDA Updates Warnings for Antibiotics – Flouroquinolone

Photo by Andreas Dress on Unsplash