Drugs

Senator Targets Firms Over Improper Patents

U.S. Senator Tammy Baldwin (D-WI) has written the four biggest drug companies marketing asthma inhalers and urged them to stop unfairly blocking generics from the market. In 1/29 letters (see below) to AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Teva, Baldwin called on the companies to stop improperly listing patents for inhalers in FDA’s Orange Book because it delays competition. “While drug companies are required to list certain patents in the Orange Book, bad actors can exploit this process to inappropriately deter competition and generic drug development, leading to fewer treatment options and higher prices for consumers,” she said in a release.

Last year, the Federal Trade Commission (FTC) issued a policy on removing inappropriate patent listings because they can be an unfair and unlawful method of competition. In November, FTC challenged ten pharmaceutical companies including AstraZeneca, GSK, Teva, and Boehringer Ingelheim for improperly or inaccurately listing more than 100 patents in the Orange Book.

“Despite these warnings, the inhaler companies have not yet removed all of the inaccurate or inappropriately listed patents from the Orange Book,” Baldwin’s release says. “In the letters sent today, Senator Baldwin called on the companies to heed the FTC’s warning, and immediately remove these patents from the Orange Book to restore fair competition for Wisconsinites who rely on inhalers to stay well.”

The letters come on the heels of Baldwin launching an investigation into the high prices the same companies charge for their inhalers.

Read letter to AstraZeneca here.

Read letter to Boehringer Ingelheim here.

Read letter to GSK here.

Read letter to Teva here.

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

Read more

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