Drugs

Use Preemption in ‘Failure-to-Market’ Cases: PRI

A Pacific Research Institute white paper explains why it believes drug manufacturers should present preemption claims when they are charged under state laws with failing to market as quickly as possible a drug that allegedly presents fewer side effects than other FDA-approved drugs already on the market. The paper says the concern arises from a California appeals court decision that held that drug companies have a duty to develop and bring to market drugs that are supposedly safer and more effective than another approved drug the company already sells.

The ruling “threatens to put drug companies in a no-win situation, in which they can be held liable in tort for both the drugs they sell and for those they decline to bring to market,” PRI says. “This additional hurdle adds cost to the drug development process while, at the same time, giving drug companies one of two undesirable incentives: either seek approval prematurely or abandon a promising line of research altogether.”

The case involves two Gilead HIV drugs — TAF (tenofovir alafedamide) and TDF (tenofovir disoproxil fumarate).

PRI says that while private attorneys can and should raise preemption arguments in response to failure-to-market claims, the federal government should address the issue through legislation if necessary. The paper recommends that the federal government intervene in all failure-to-market cases if they are remanded to trial.

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