Weekly Roundup 6.5.15

It has been a week of rain and gloom in our nation’s seat of government. It has been cold, gray and unpleasant. Commutes are nasty. The lack of sunshine is getting serious. But on the bright side, pollen has been washed away, the garden appears happy and baby birds have hatched in one of the hanging baskets of flowers I keep on the front porch. So the glass remains more than half full.

Here is a bit of what happened in FDA-world and a little beyond this week that I thought noteworthy and hope you do too:

  • NIH Suspends Operations of its Clinical Center Pharmaceutical Development Section Following FDA Inspection – Big oops. On Thursday this week NIH announced that it had suspended operations of its own Pharmaceutical Development Section (PDS) following an FDA inspection. According to the release, FDA responded to the receipt of a complaint and conducted an inspection in late may and discovered what NIH termed as “serious manufacturing problems and a lack of compliance with standard operating procedures.” NIH Director Francis S. Collins, M.D., Ph.D was quoted as saying that he would be personally overseeing the steps to address the situation.  The inspection report is located here and media coverage here.
  • Congressman Concerned Over FDA Inspection Letters – And speaking of FDA inspections, Ed Silverman this week reported on the Wall Street Journal Pharmalot site an interesting development. Congressman Tim Murphy has sent a letter to FDA seeking details related to the agency’s policies in posting untitled letters regarding manufacturing problems discovered in the facilities of companies making pharmaceuticals. Specifically, he is looking for insights on the timing of posting such letters along with what does into the decision into how detailed the letters are when posted. The concerns seem to be related not to warning and untitled letters from the Office of Prescription Drug Promotion, but rather those that are results of inspections of facilities. The letter was sent ont he 27th of May – no word as to when FDA will respond or if the response will be posted.
  • AdComm Approval for HSDD Drug – There have been past attempts to provide a treatment for women experiencing Hypoactive Sexual Desire Disorder but this week we saw the first to get a recommendation for approval by an FDA Advisory Committee. Sprout Pharmaceuticals announced that the company’s investigational product ADDYI (flibanserin) was recommended for approval in an 18-6 vote on the condition that certain risk management options beyond labeling are put into place. While men have had many pharmaceutical options for the treatment of erectile dysfunction, relief for women has not been as forthcoming. All eyes now go to FDA to see what it will do in response to the recommendation.

That’s it for me this week. Have a great weekend everyone.

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