Drugs

House Drug Price Bill Keeps New Drugs Away: White House

The White House Council of Economic Advisors (CEA) says that H.R. 3, the Lower Drug Costs Now Act of 2019, could keep as many as 100 new lifesaving drugs off the market. The CEA also estimates that by limiting access to lifesaving drugs, the bill would reduce Americans’ average life expectancy by about four months, or nearly one-quarter of the projected gains in life expectancy over the next decade.

A White House statement says the bill would lower drug prices for select drugs by effectively forcing drug manufacturers to accept prices set by the HHS secretary or face an excise tax of up to 95% of sales. The tax would not be deductible for income tax calculations, so drug manufacturers could lose money from selling the drug. Thus, the statement says, companies would have to accept the HHS price for a given drug or decline to sell it in the U.S.

The statement praises the Trump administration’s approach using market-based mechanisms such as approving new generics and removing barriers to drug innovation, and says that approach “has provided Americans with the largest and longest drop in drug prices over five decades…. Heavy-handed government intervention may reduce drug prices in the short term, but these savings are not worth the long-term cost of American patients losing access to new lifesaving treatments.”

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