Drugs

GOP Reps Challenge Generics from ‘Alert’ Firms

A 4/13 letter from five House Republicans is questioning FDA commissioner Robert Califf on agency safeguards in place when questionable foreign-made generic drugs are allowed to enter the country to prevent drug shortages. At issue is FDA’s decision to allow Glenmark Pharmaceuticals to import atovaquone from a facility that was under an import alert. The drug is used to prevent or treat a serious lung infection called Pneumocystis pneumonia.

“We are increasingly concerned that the choice facing Americans is to either have a supply of potentially unsafe generic drug imports from foreign manufacturing facilities that have violated FDA regulations or to have no supply of generic drugs at all,” the lawmakers write in the letter. “In our view, this is an unacceptable choice. The FDA, along with Congress, must seek to resolve this crisis.”

The letter asks Califf to respond to the following questions:

Does FDA have a procedure in place to ensure that hospitals and pharmacies are alerted that they have purchased products from a facility that the agency has placed under import ban, even if the manufacturer was later granted an exception?
Does FDA test generic drug imports from facilities that have received a Warning Letter?
Does FDA test generic drug imports from facilities that have been placed under an import ban and then later granted an exception?
When a generic drug is in shortage, does the FDA have a procedure in place to identify a domestic manufacturer of that drug?
When a generic drug is imported from a foreign manufacturer that has received a Warning Letter, does the FDA have a procedure in place to identify products made domestically?

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome