Drugs

Trump Takes Aim at Drug Price Hikes

President Trump has his sights on the drug industry after the latest round of price increases on dozens of products. In a 7/9 tweet, the president said: “Pfizer & others should be ashamed that they have raised drug prices for no reason. They are merely taking advantage of the poor & others unable to defend themselves, while at the same time giving bargain basement prices to other countries in Europe & elsewhere. We will respond!” In an unusually swift about-face, Pfizer said it would roll back its increases following “an extensive discussion with President Trump,” according to the Wall Street Journal.

That one company aside, Trump’s ire may ring hollow as the administration has asserted before that drug pricing is out of control and promised that a fix was imminent -- without evident results. “The secretary of HHS has a shocking amount of power by the stroke of a pen, and we intend to exercise it,” HHS secretary Alex Azar told PBS News Hour 5/14, addressing the cost of prescription drugs paid by Medicare for senior citizens − an issue FDA commissioner Scott Gottlieb has committed the agency to address through drug approval policies and authorities. A former Eli Lilly president, Azar was being questioned by PBS News Hour anchor Judy Woodruff about reports that the Trump administration intends to press industry to post prices in its direct-to-consumer advertisements. So far, no policy changes have been effected.

Also in May, the administration released a blueprint for lowering prescription drug prices, which has had little effect in reducing recent price hikes. The blueprint included 50 actions the administration said it was willing to take to lower drug costs to consumers. These included:

Taking steps to end the gaming of regulatory and patent processes by drug makers to unfairly protect monopolies.
Advancing biosimilars and generics to boost price competition.
Streamlining and accelerating the approval process for over-the-counter drugs.
Speeding access to, and lower the cost of, new drugs by clarifying policies for sharing information between insurers and drug makers.

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