Phew – candy handed out and leftovers gobbled up at the office. I am safe. Now comes the rather heavy preparation for Thanksgiving to receive guests and prepare feasts. That, combined with extreme business foreclosed an intermediate posting this week that I had planned, but there is always next week. In the meantime, it has also been a busy week in all things FDA and here is a bit of what happened this week that I wanted to share.
Menu Labeling to Proceed (cautiously) – There has been a good deal of back and forth related to the issue of information available on restaurant menus so that consumers can make informed choices about what they eat, with particular regard to the calories being consumed. The agency has been at this a long time, with the first rule for menu labeling proposed in 2011. Let that sink in. This year, another round feedback was received by the agency and now FDA has released a draft guidance that takes into account the feedback received through this long process though it states at the very top that it is non-binding and being issued for comment purposes only. In an accompanying statement, Commissioner Gottlieb states that FDA takes seriously its authority in this regard, but is committed to responsible implementation as well. That appears to include gathering more comment and setting a new date – May 7, 2018, as a potential compliance date. A lot can happen between now and then and in the meantime, we will just have to trust our instincts.
New Treatment for Rare Blood Cancer – The banner year for cancer approvals – and for approvals for rare diseases – continues with the announced approval of Zelboraf (vemurafenib) as the first medication availble to treat some adult patients with Erdheim-Chester Disease (ECD). ECD is a slow-growing blood cancer originating in the bone marrow that can result in the grown of tumors in many organs and tissues throughout the body. Zelboraf, a kinase inhibitor, will be used to treat patients with a specific BRAF V600 mutation, which will be just over half of those who have ECD and works by blocking enzymes that promote cell growth. The approval came through priority review and has a breakthrough therapy designation as well as orphan drug status. The company release can be found here.
FDA Clears New CBC Test – One of the most common blood tests ordered in a physician office is the complete blood cell count (CBC) helping to assess the health of a patient from a number of perspectives. This week FDA announced approval of a test that can be run in the physician’s office and in other health care centers and performed by a wider range of staff which means faster results meaning not only faster diagnosis but ushering the way for faster access to treatment. Currently such tests are often performed offsite and can take at least 24 hours for results. The approval took place under a regulatory pathway designed to facilitate a streamlined evaluation process. The company press release can be found here.
Upcoming Events to Keep an Eye on This Week
- Senate HELP Committee Hearing – Gene Editing Technology: Innovation and Impact – On November 14, the committee will hear from three witnesses regarding gene editing technology.
- Partners in Progress: Cancer Patient Advocates and FDA – On November 13 FDA will hold a meeting to provide basic training on the role of the FDA and cancer patient advocates in product development – deemed as most relevant for those with limited knowledge and experience in cancer product development.
- Antimicrobial Drugs Advisory Committee – On November 16 to discuss NDA for ciprofloxacin inhalation powder for reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) in patients with respiratory bacterial pathogens.
- Device Referencing Drugs – On November 16 FDA is holding a public meeting to get input on potential approach for certain device sponsors to get marketing approval for devices that are labeled for use with a drug already on the market when the sponsor of the drug does not want to pursue the new use.
Regulatory Developments in Pharma/Biotech/Devices