Drugs

Industry Attacks Dems’ Drug Price Plan

An analysis commissioned by Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization, and the Council of State Bioscience Associations, warns that H.R. 3, House Democrats’ drug pricing plan, “could result in 56 fewer new medicines over 10 years.” The analysis projects that the bill would cut revenue by more than half for companies with affected medicines, leading to a nearly 90% reduction in new medicines developed by small biotech companies. “This would have a disproportionate effect on industry work with small biotech companies, forcing hard choices and moving capital away from riskier investments where the science is tougher and economic returns are less certain,” a PhRMA news release (contains link to the full analysis) says.

While the Congressional Budget Office has estimated that only 8-15 medicines would be stopped from coming to market over the next 10 years, PhRMA says, its analysis shows that small, emerging biotech companies alone would bring 56 fewer new medicines to market over the next 10 years, down from 64 during the previous decade. “After factoring in the full ecosystem of biopharmaceutical innovation, the real impact on patients gaining access to new medicines will be significantly worse than that if H.R. 3 is enacted,” the statement says.

Much of the problem, according to the analysis, lies with the foreign reference pricing concept in H.R. 3.

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