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We Can’t Wait (on drug shortages)

With Congress refusing to debate his jobs bills, President Obama has started using executive orders to get at least something done, as part of a campaign called “We Can’t Wait.” While it’s good that he’s at least trying to move forward when Congress fails to act, the campaign mostly highlights how little the President can do without their approval.

For example, on Monday President Obama signed an executive order to tackle the growing problem of prescription drug shortages. Shortages have tripled since 2006, with over 200 scarce medicines reported last year alone:

“The types of products we’re seeing shortages of are really concerning,” said Valerie Jensen, who heads the FDA’s Drug Shortages Program. “This is affecting oncology drugs, critical-care drugs, emergency medicine drugs. We’re doing everything we can under our current authority to try to deal with this situation.”

Drug shortages have been a tricky issue for regulators to deal with, because the causes are different from drug to drug:

Experts cite a confluence of factors: Consolidation in the pharmaceutical industry has left only a few manufacturers for many older, less profitable products, meaning that when raw material runs short, equipment breaks down or government regulators crack down, the snags can quickly spiral into shortages.

Obama’s executive order will increase staffing in the FDA office of drug shortages and requires them to report possible price gouging to the Justice Department (certain distributors have been exploiting the shortages to charge hundred-fold markups). It also forces certain drug companies to give more advance warning of possible shortages.

The advance notice part is important– it allows the FDA to work with other drug companies to manufacture drugs that would otherwise be in short supply. But under current law, the executive order can only apply to some companies. A better solution will require action from Congress, as The Washington Post reports:

Right now, federal law requires reports only from “single source” drug manufacturers, those that are the sole producers of a given medication. Pending legislation in the House and Senate would require all drug manufacturers to report looming shortages.

That bill has been stuck in Congress since February, despite bipartisan support.

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