Drugs

House Hearing Planned on Rx Drug Market

The House Committee on Oversight and Government Reform has planned a 1/26 hearing on “Developments in the Prescription Drug Market: Oversight.” The committee has reportedly asked former Turing Pharmaceuticals head Martin Shkreli to testify, along with Valeant Pharmaceutical's interim CEO Howard Schiller.

Rising drug prices have caught the attention of Capitol Hill, health insurers, consumers, and presidential candidates. A recent Huffington Post blog article by University of Pennsylvania professor Ezekiel J. Emanuel notes that drug prices in the U.S. rose almost 14% last year despite health care inflation falling to historic lows. He dismissed industry arguments that the reason drugs costs are so high is that they need the money to conduct research for new products.

After examining how drug companies actually spend their money, Emanuel says research does not dominate. “Rather, more of the money goes toward funding marketing budgets and realizing profits,” he writes. He proposes an approach for drug companies similar to the Medical Loss Ratio (MLR) policy in the Affordable Care Act, which requires insurance companies to spend at least 80% of their premium revenue on actual health care, and has actually helped moderate health insurance premium increases.

“Like the MLR policy,” he continues, “this proposal would require drug companies to spend a certain proportion of their revenue or invested capital on research, holding them accountable for their rhetoric on research spending. If the percentage of their research budget is too small, then they would be assessed a penalty that would be given to biomedical research institutions, like the National Institutes of Health, which generate the basic research that drug companies later develop into actual drugs.”

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