Physicians Press U.S. to Require Reporting of Drug Shortages

Drugmakers should be required to establish plans to ensure the supply of crucial medicines such as cancer treatments, said a panel of doctors urging that the American Medical Association lobby for such a move.

The group’s House of Delegates is expected to vote to adopt the recommendation as its policy as soon as this afternoon. The move by the largest U.S. physician lobby may increase pressure on lawmakers and manufacturers such as Johnson & Johnson, based in New Brunswick, New Jersey, whose cancer drug Doxil has been in short supply this year.

Shortages of Doxil and other medicines “are a complex problem that will require a multipronged approach to solve,” the AMA panel chaired by Oklahoma University medical professor Robert McCaffree wrote in a report issued this morning.

President Barack Obama directed U.S. regulators on Oct. 31 to gather information about potential drug shortages so the government can respond before patients’ lives are threatened. The administration said early notice will allow it to work with manufacturers to find alternate sources for treatments.

Johnson & Johnson supports “the concepts of identifying and describing shortages,” said Lisa Vaga, a spokeswoman, in an e-mail. The company also wants quick FDA plant inspections to re-start production in the event of a shortage.

There have been 232 drugs in short supply so far this year, most generic injectable drugs for cancer and anaesthesia, said Bona Benjamin, director of medication-use quality improvement for the American Society of Health-System Pharmacists, in a presentation to AMA delegates. That is the highest number of shortages in at least a decade, according to the University of Utah Drug Information Service.

Panels Hear Testimony

“We know there has been patient harm and even patient deaths” from shortages, Benjamin said. Fifty-four percent of the causes are due to “production quality issues” at drug factories, according to the U.S. Food and Drug Administration.

Five separate AMA panels met yesterday to hear doctor comments and weigh issues and language that will be put before the association’s governing body for votes today.

A push by Ohio doctors to get delegates to support exemptions from an insurance mandate in the 2010 health-care law for states was rebuffed by a legislative panel in a report today. The resolution introduced by Kettering, Ohio obstetrician Lisa Egbert, shouldn’t be approved because states already can follow different paths to offer coverage without opting out of the mandate, the report said.

Undermining Policy

Such a resolution “could undermine AMA policy on individual responsibility” and the group’s positions insurance regulations contained in the law, according to comments by the panel, led by Barbara Arnold, a California ophthalmologist.

That same panel supported a vote on a plan to urge states to design health insurance exchanges that accept all plans, regardless of price, when they open in 2014. The group said this approach would give consumers more choice.

Debate yesterday often mirrored the national political divide over the health-care law and its effects, said Tom Price, a Republican Representative from Georgia who is an orthopedic surgeon and AMA delegate.

There is “continued exasperation and frustration among actively practicing physicians” over the law, he said.

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