Drugs

Potential for REMS Misuse ‘Substantial’: Study

A Matrix Global Advisors paper estimating the market for REMS (Risk Evaluation and Mitigation) and other restricted distribution programs concludes that while there are valid public health reasons for restricted access programs for certain drugs, brand manufacturers can use the programs to block generic competition, with a direct negative impact on consumers and taxpayers. “Compared to the size of other prescription drugs that have generated policymaker and public ire,” the report says, “the potential for misuse of REMS and other restricted access programs is substantial.”

The Matrix analysis finds that the restricted access drug segment comprises 74 drugs with total 2016 sales of $22.7 billion. Of the 74, 41 are restricted by REMS programs, with sales totaling $11.5 billion. The remaining 33 drugs are restricted by non-REMS programs, with total sales of $11.2 billion in 2016. Seven of the drugs (four with REMS and three with non-REMS restrictions) have sales over $1 billion, representing just over 50% of total sales.

“Given the size and scope of the pharmaceutical market subject to a REMS or similar distribution restriction, this issue warrants attention on the scale of other high priced drugs that have generated headlines and congressional inquiries,” the report concludes.

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

Read more

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