Weekly Roundup 1.19.18

As noted below, next week the Senate HELP Committee will hold Part 2 of a hearing series on public health threats in the 21st Century. Ironically this comes at the same time we are facing a series of deadlines to keep the government funded and open when in fact, a threat to public health is manifest in a government shutdown. One wonders if they will include the inability of Congress to function as a 21st Century threat in their deliberations. 

But closer to our world, it was a busy week at FDA and in healthcare overall. FDA issued five press statements in a single day this week – one of which was regarding a new pilot program in transparency discussed in a posting on Wednesday. In addition, here is a bit of it that I’d like to bring to your attention. 

  • Shutdown Impact – What Does it Mean? – As of this writing there is a diminishing pathway for an agreement that will keep the government open. The impact of failure on FDA is  bit murky. For those with long memories, the last time this happened it occurred for an extended period of time and FDA had to furlough a large portion of the workforce. What does that mean for those with business before the agency?  The last time, there was an effort to continue with user fee funded activities. If that holds true, it may not affect PDUFA date announcements (I count at least 15 PDUFA dates upcoming between now and the end of February). For public meetings scheduled during a time of shutdown, they may have to be a delay. Last time inspections were said to have stopped and it is probably safe to say that the Office of Prescription Drug Promotion will unlikely issue any letters. For media announcements,  it is also my recollection that there was a brave soul who stuck it out in the FDA media office. I
  • Administration Announces New Division on Religious/Moral Protection – Health and Human Services announced the opening of a new division within the HHS Office for Civil Rights (OCR) to support the positions of those who have “rights of conscience and religious freedom” the purpose of which is to enforce federal laws protecting those rights. In the release about the new division, the head of OCR stated that “too long, governments big and small have treated conscience claims with hostility instead of protection, but change is coming and it begins here and now.” The rationale for the action rests in part, the release said, on not having people being “forced to choose between helping sick people and living by one’s deepest moral or religious convictions…” There was no mention on ensuring access for the sick to unbiased care. 
  • FDA and Department of Defense Launch Program for Expediting Approvals for Military – In 2017, concerns on the part of some that FDA moved too slowly in approving new medical products used in combat care resulted in the possibility of approval authority for emergency use of unapproved products to the Department of Defense (DoD). Some media reported that Commissioner Scott Gottlieb had urged for the authority to remain with FDA and suggested an alternative means of expediting access to such products for military use. This week FDA announced a joint program that would do just that. The program is described as one whereby DoD would request FDA to expedite development of reviews of products for American military use and that FDA would then treat such products in a manner similar to what is available under the existing breakthrough designation that FDA now provides for drug manufacturers, meaning the medical product under consideration will receive involvement of top senior managers, intensive guidance and all features of Fast Track designation.

Upcoming Events to Keep an Eye on This Next Week

Regulatory Developments in Pharma/Biotech/Devices

Photo by Kailen Gingell on Unsplash


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