- The Washington Times - Wednesday, January 9, 2019

The Food and Drug Administration is shifting funds during the government shutdown to prioritize drug safety surveillance over pre-market drug review work, the agency’s commissioner has announced

“We’re making decisions across our portfolio to focus #FDA resources to key consumer protection functions. One action we’ll be taking is to re-allocate user fee money from certain pre-market drug review work to post market drug safety surveillance,” Dr. Scott Gottlieb said Tuesday in a tweet.

 

 

The FDA on Tuesday issued a recall for almost 14,000 units of an anesthesia companion injection made by Sun Pharmaceuticals because the medication contains pieces of glass. If injected into the blood stream, it could cause irritation at least and, at worst, a life-threatening blockage or clot.

The agency also has dealt with a number of recalls for certain blood pressure medications. Last week, Aurobindo Pharma USA recalled dozens of lots of Valsartan because of the presence of a known carcinogen. 

In November, Valsartan medications produced by pharmaceutical companies Mylan and Teva were recalled for the presence of known carcinogens. 

Dr. Gottlieb said more details on the agency’s efforts would be available in the coming days.

“All of our work at the #FDA is critical, so nothing we stand down is unimportant. But the functions that can most directly impact consumer safety will continue, to the best of our abilities, subject to the legal and financial limitations of the current circumstances,” the commissioner said on Twitter.

 

 


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