Drugs

Teva, Others Try to Resolve Price-Fixing Probe

Teva and other generic drug companies have held talks with the federal government over the last six months in an attempt to resolve a long-running criminal antitrust investigation into alleged price-fixing. Bloomberg News reports it has learned from sources familiar with the matter that among the possible outcomes could be deferred prosecution agreements in which the companies would admit to certain allegations but would be shielded from indictment in exchange for cooperating with the investigation and paying fines.

The news service sources said talks are being held with the generic drugmakers individually and any one or all of the negotiations could fail to result in an agreement. The timetable for reaching a resolution isn’t clear, Bloomberg says.

The Justice Department wouldn’t comment on the story and spokespersons for companies either said they continue to cooperate with the government or wouldn’t comment.

Prosecutors reportedly have been investigating allegations that generic drugmakers conspired to prop up the prices of certain widely-used medicines for more than five years, and have hinted several times this year that charges could be imminent.

The news service says the investigation poses a problem for the government because it wants to make drugs as affordable as possible, and yet a conviction of a generic drug company could lead to it being barred from government healthcare programs, which would drive up costs to the programs. Using deferred prosecution could avoid a conviction that would inadvertently limit competition and increase the prices of common medications, it says. It would also wrap up a case that has targeted the biggest names in the industry but has yet to produce charges against any major company.

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