Drugs

Glaxo Resuming Some Doctor Payments

GlaxoSmithKline says it is revising its policy on working with healthcare professionals to allow payments to some doctors who promote company products. “This policy update is being made to ensure we continue to operate responsibly and improve how we help prescribers to understand new data and clinical experience with our innovative products, so they can deliver better outcomes for patients,” a company statement says.

Reuters says the announcement reverses a policy adopted in 2013 when GSK was the first company to ban such payments following industry-wide sales practice scandals. Other companies failed to follow suit, the news service says, leaving GSK at a competitive disadvantage.

According to the company statement, the new policy covers a select number of innovative products in a limited number of countries and only during restricted time periods in a product’s lifecycle. Under the policy, in certain circumstances GSK will:

make payments to global expert practitioners who speak about the new science behind GSK innovative products, their associated diseases, and clinical practice in promotional settings;
pay reasonable travel costs (except in the U.S.) for a healthcare professional to attend a GSK-organized standalone meeting to learn about data and clinical experience; and
directly pay registration fees for healthcare professionals to attend remote congress webinars/webcasts, while continuing to not sponsor healthcare professionals to attend local and international conferences.

The company says it will expand its reporting of payments to individual healthcare professionals as part of its commitment to transparency and responsible disclosure.

A source told Reuters that overall the total payments under the new policy are expected to be significantly below pre-2013 levels.

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