FDA Policy/General

CMS Ad Drug Price Rule Questioned

Consumers are likely to be confused if the Centers for Medicare and Medicaid Services goes ahead with its rule requiring drug companies to show in TV ads the list price of all medicines covered by Medicare or Medicaid that cost $35 or more for a one-month supply or a full course. That’s the conclusion of an online Forbes article and the experts who spoke to the magazine about the proposal.

The list price is defined as the initial price charged to federal and private insurers and pharmacy benefits managers. “List prices can be vastly different from the average American’s out-of-pocket cost for prescriptions,” the article says.

The problem arises, according to Forbes, because about 91% of Americans have health insurance of some kind and for them the list price is irrelevant. And the Trump administration says that just 47% of Americans have high-deductible health plans requiring them to essentially pay the list price until their deductible is met.

Pharmaceutical Research and Manufacturers of America is protesting the CMS proposal, saying it presents “operational challenges” and may violate companies’ First Amendment right to free speech.

Forbes says that the question of whether forcing drug companies to disclose lower prices will actually result in lower prices, as President Trump has predicted, “is a matter of fierce debate.” A study published in JAMA Internal Medicine found that when consumers were shown ads with price information for fictional drugs, their interest in the most expensive drugs fell by 43%. However, when the ads included language explaining that insurance coverage or discounts would result in lower out-of-pocket costs, demand for the products remained strong.

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