Drugs

WA State Court Backs Learned Intermediary in DTC Case

The Washington State Supreme Court ruled 6/2 that the state does not have any drug direct-to-consumer advertising exception requiring pharmaceutical marketers to specifically warn patients about potential adverse events when drug products are advertised directly to consumers. When a drug marketer advertises its products directly to consumers, “it satisfies its duty to warn a patient when it adequately warns the prescribing physician of the drug’s risks and side effects,” the state supreme court ruled.

The ruling was made in response to a question posed to it by the Western District of Washington federal court related to a product liability suit it is hearing (Dearinger vs. Eli Lilly) over injuries caused by Lilly’s Cialis. Dearinger claims that the company knew or should have known Cialis presented a risk of stroke to its users and failed to adequately warn users of the risk.

The policies underlying the learned intermediary doctrine remain intact even in the direct-to-consumer advertising context, the state high court said. “This case raises the question of who the manufacturer must warn,” the court said. “In the context of prescription drugs, the learned intermediary doctrine provides ‘the manufacturer satisfies its duty to warn the patient of the risks of its product where it properly warns the prescribing physician.’” It found that a drug company’s duty to warn transfers to physicians because they are in a better position to communicate warnings to patients.

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