Drugs

U.S. Penalties on Drug Makers Seen as ‘Cost of Doing Business’

Harvard Medical School professor Eric Campbell says that the “financial rewards companies reap” from engaging in behaviors that result in payments to settle civil and criminal cases “far outstrip any penalties they pay.” Campbell is quoted in a Fair Warning online story on a Public Citizen report detailing major drug company settlement payments between 2006 and 2015. Treating fines as a cost of doing business, Campbell says, “truly appears to be the business model in marketing drugs.”

The Public Citizen March report showed a significant drop in drug industry criminal and civil settlements in the last two years. The group now has released company-specific totals for the period 2006-2015. In the 10-year period, the advocacy group says, 21 companies entered into two or more settlements with the federal government: Pfizer (9), Merck (7), GlaxoSmithKline, Johnson & Johnson, and Novartis (6 each), Teva and Bristol-Myers Squibb (5 each), AstraZeneca (4), and Abbott, Amgen, Sanofi, and Novo Nordisk (3 each).

The Fair Warning online story on the report suggested that many companies view the financial penalties they pay as a cost of doing business since the settlements amount to less than 5% of the net profits of the 11 largest global drug firms over the study period.

Public Citizen’s company-specific chart shows that GlaxoSmithKline paid $7.628 billion over the 10 years in 26 settlements. The next highest was Pfizer, with $3.458 billion in 28 settlements. The lowest payment it records was Mylan’s $566 million in 20 settlements.

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