Weekly Roundup 3.9.18

Another busy week – tried and failed to squeeze in a posting between the Weekly Roundup, but am well set up for next week. The Northeast had another Nor’easter. And yet here we are once again ready to Spring Ahead and set our clocks for Daylight Savings this weekend on March 11 at 2 AM. Our mornings will be a little less bright, but our evenings will be full of light. 

In fact, it was a busy week at FDA too. And speaking of light, here is what I wanted to shed some on:

  • Commissioner Gottlieb Remarks on Biosimilars Market – This week in a speech delivered before the American Health Insurance Plans’ (AHIP) National Health Policy Conference, Commissioner Gottlieb delivered remarks that for many reasons caught the attention of many and lit up the Twittersphere.  FDA does not regulate price, but in addressing market place conditions that limited access to biosimilars and which he stated disincentivize developers of biosimilars, the matter was one of public health and therefore in the purview of FDA.  He stated that the current economics of biosimilar development are “unstable”. He cited current rebating and contracting practices along with market consolidation as being factors that are undermining the market and in fact, leading some stakeholders to have an incentive to limit update of less expensive biosimilars when they become available meaning that both patients and biosimilar manufacturers. You can see the full text of his remarks here. 
  • FDA Clears First DTC Gene Test for Cancer– It is not only the first DTC genetic test for reporting on cancer mutations, but it is also one aimed at a specific population. This week FDA approved a test that analyzes DNA and produces a report that will indicate that a woman is at increased risk of developing breast and ovarian cancer or if a man is at increased risk of developing prostate cancer. Detecting only three out of the more than 1000 known BRCA1/BRCA2 mutation that increase cancer risk, the test reports on those mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. While providing this information, the test is limited in its applicability, not detecting other mutations that may cause cancer and so a negative test does not rule out the possibility of cancer risk. The test was approved through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate risk devices that are not substantially equivalent to an already legally marketed device. The company press release can be found here
  • More Flu Blues – One item not picked up before publication time from last week was that FDA issued a warning against fraudulent and unapproved flu products that have entered the market during what has been a particularly difficult flu season. The agency reminded the public that there were no OTC approved products that could prevent or reduce the length of tie one suffered from flu. This week in a hearing before the House Energy and Commerce Committee on the topic of flu preparedness, the FDA Commissioner also warned against high hopes with regard to the development of a universal flu vaccine which he said was “many years off”. Instead he outlined the need, and what progress there has been, in moving away from egg-based development of vaccine to cell-based and the steps FDA is taking to facilitate that migration. 

That’s it for me this week folks. Don’t forget to set the clocks and cheat yourselves out of an hour from the weekend. Have a good one!

Upcoming Events to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

Photo by Shane Rounce on Unsplash


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