Weekly Roundup 8.10.18

The summer creaks onward. In less than a month it will be Labor Day. I don’t know about you, but I find that almost incomprehensible. The folks on Capitol Hill are gone, which makes traffic here almost bearable. We like it that way. You can keep them all home if you like. One note related to the posting last week regarding the increase in the number of Commissioner Statements from FDA – this week there were none!  That hasn’t happened since May. In spite of the quiet, some notable things have happened, so let’s saddle up and round up some news.

  • FDA Approves First DTC App for Prevention of Pregnancy – It is perhaps an historic first for Direct-to-Consumer as well as medical app support as well as contraception that FDA approved today a mobile app to support women in contraception to prevent pregnancy. The app works by providing support in the monitoring of conditions that would signal a likelihood of fertility on certain days – a method of contraception referred to in the FDA release as fertility awareness.  Clinical studies to evaluate the efficacy of the app involved over 15,000 women who used the app for an average of eight months. Remember when you used your phone to make phone calls? 
  • Approval in Non-Hodgkin Lymphoma – Non-Hodgkin lymphoma is a blood cancer that begins in the white blood cells. Two types of disease are Mycosis fungicides (MF) and Sezary syndrome (SS), both rare and difficult to treat. FDA announced approval of Poteligeo, a monoclonal antibody, with an indication to treat both of these types of non-Hodgkin lymphoma for patients with relapsed or refractory forms of MF/SS where there has been a prior systemic treatment . Poteligeo was given Priority Review and had Breakthrough Therapy status as well as Orphan Drug designation. The company press release on the approval can be found here
  • New Generic Regulatory Pathway Sees First FDA Approval – FDA has very limited authority to impact the price of medications through its regulation of the pharmaceutical industry. However, the more generics that are on the market for specific conditions, then the more pricing pressure there is on manufacturers and generally the lower the price will go. With some treatment categories experiencing a lack of available generics, a new Competitive Generic Therapy Designation was put into place to expedite the development and review of a generic drug where there is a lack of competition. This week saw the first approval under that designation with the FDA approval of a generic potassium chloride oral solution for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics.  Ultimately pricing impact will depend on the number of drugs that utilize this category as well as the number of conditions affected. Time will tell. 
  • FDA Expands Valsartan Recall – Back in July, FDA issued a press release announcing a recall involving some valsartan products prescribed for the treatment of high blood pressure. Since that time there have been a number of updates to the initial recall. The focus has been the presence of NDMA in some active pharmaceutical ingredient.  The update from this week includes updated lists of products that are under recall as well as a list of products that are not under the recall. Both lists can be accessed in the most recent update. FDA is continuing its investigation and will provide further updates. 

Things to Keep an Eye on This Week

  • No hearings
  • No AdComms
  • No FDA meetings
  • It’s August…..

Regulatory Developments in Pharma/Biotech/Devices


Photo by Jez Timms on Unsplash

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