FDA Policy/General

Pfizer Settles Oregon Marketing Suit for $975,000

Oregon attorney general Ellen Rosenblum says Pfizer will pay $975,000 to settle state charges that it distributed misleading marketing materials and coupons to Oregon consumers. Rosenblum says the coupons were designed to help consumers afford copays or deductibles associated with branded drugs.

Some $620,000 of the settlement money will go to two state organizations that each help underinsured and uninsured residents afford health care.

Rosenblum says that after a four-month investigation, the state Department of Justice determined that Pfizer distributed misleading marketing materials and coupons that said consumers would “pay no more than” a certain amount such as $15, $20, or $25 at the pharmacy for the company’s Flector Patch, Estring, and Quillivant/Quillichew. In reality, she said, many consumers had to pay significantly more. She said the investigation identified 371 customers who paid more than $40,000 in total over the amount promised by the coupon the first time a prescription was filled.

Rosenblum’s news release says that since 2003 Oregon has recouped over $10 million in civil settlements from Pfizer.

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