Weekly Roundup 11.9.18

So much to talk about, so little time. The election (thankfully) is over. The days are shorter, darker, wetter and altogether more lean. Thanksgiving is but a few short weeks away and Christmas decorations are already sneaking their way into stores and our psyche. There is a rush to finish all that needs to be finished before the end of the year, and perhaps it is no different at FDA where there has really been a good deal of activity over the calendar year, much of which we will visit in some year-end look-backs. In the meantime, here is what happened this week. 

  • FDA and Expanded Access – Expanded access to drugs under clinical study is important on many levels – access for the patient, protecting the integrity of clinical trials, and of course patient safety. In a statement this week, FDA Commissioner Gottlieb announced improvements to the expanded access program that streamline the process even further by requiring less documentation and involving fewer individuals in the approval process. The agency also clarified how adverse events experienced through the expanded access pathway would be considered in the context of the review process for investigational treatments. In addition, changes have been made to improve the usability of the expanded access website, reducing duplication and adding new pages of commonly requested information. The statement also clarified that this program is distinct from the “Right to Try” legislation signed into law earlier this year and that FDA is in the process of considering what steps are needed to implement that legislation. 
  • OTC Asthma Medicine Returns – Commissioner Gottlieb and CDER Director Janet Woodcock issued a joint statement this week about the return to market of a new version of Over-the-Counter Primatene Mist, the only OTC metered-dose inhaler for use in providing temporary relieve to mild, intermittent symptoms of asthma. It is approved only for persons who have been diagnosed with asthma by their healthcare provider. While there was a former version of OTC Primatene Mist, it was removed from the market in 2011 due to the fact that it contained chlorofluorocarbons (CFC) propellants known to be harmful to the earth’s ozone layer. In the wake of the removal, the two said that there were considerations as to whether having an OTC asthma product improved access for patients or actually caused patients to forestall needed treatment. They acknowledged that there is a narrow population of people diagnosed for whom an OTC asthma inhaler would have benefit, but that appropriate use needed to be reinforced. 
  • Deadline Today on FDA Response to Senator Inquiries on Pre-Cert Program – On October 10, 2018, Senators Warren, Murray and Smith sent a letter to Commissioner Gottlieb and to CDRH Director Jeffrey Shuren containing a long-list of inquiries about the nature of the FDA pre-certification program for software being used in medical devices. The letter included nearly two dozen questions on a range of topics including particulars about the legal underpinnings of some of the aspects of the proposed pilot program that FDA is developing to allow specific manufacturers to facilitate the pathway to market for software used in some medical devices. The deadline for FDA’s response was today, November 9. 

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices/Food

Photo by Jarren Simmons on Unsplash

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