Obama takes action on drug shortages

President Barack Obama signed an executive order on Monday to address an escalating shortage of life-saving medicines, his newest effort to advance social and economic measures that have stalled in Congress.

It was the fifth in a series of unilateral steps by Obama over the past week to seize the initiative from his Republican foes and show voters he is serious about tackling the country’s problems ahead of the 2012 reelection campaign.

Obama instructed the Food and Drug Administration to get better advance warning of impending supply problems and speed up its review of applications from companies that want to change or ramp up production to address shortages.

Doctors and patient advocates say shortages of certain drugs, such as some chemotherapy treatments and antibiotics, have forced providers to postpone care or use second-best or costly alternatives.

The order reflects a proposed law on the shortages that has been stuck in Congress, despite bipartisan support. However, the order lacks the authority of legislation and U.S. health officials cautioned that its impact could be limited.

“Congress has been trying since February to do something about this. It has not yet been able to get it done. It is the belief of this administration that ... we can’t wait,” Obama said during an Oval Office ceremony to sign the order.

“I still urge Congress to move forward and build on this executive order.”

Since Republicans in Congress sidestepped his $447 billion jobs plan, Obama has also invoked his executive powers to help homeowners, students, veterans. His approval ratings currently languish near the 40-percent range over his economic stewardship.

Republicans called on Obama to do more to help the economy and create jobs.

“This move isn’t going to cut it,” said Brendan Buck, a spokesman for House Speaker John Boehner, speaking about Monday’s executive order. “The President should end the photo-ops and campaign-style barnstorming, and work with us.”

FDA Commissioner Margaret Hamburg said the latest order would not be able to prevent all future drug shortages. “But we can make a really meaningful difference by expanding our net of early warnings,” she told reporters.

FDA officials have been investigating the problem but have had trouble identifying a root cause and coming up with a solution.

There are over 200 scarce medicines this year alone, up from 56 in 2006, according to the FDA. Most of them are cheaper generic drugs that have been around for years, and yield low profit margins for their manufacturers.

PREVENTIVE MEDICINE

The executive order also requires the agency to give the Department of Justice information about possible price gouging in the so-called “gray market,” where distributors are suspected of exploiting the situation to peddle drugs at hundred-fold markups.

It allows FDA to hire six more staff to deal with the issue, up from five people currently working in its office of drug shortages.

The FDA has said early notification allowed it to prevent 137 shortages in the past two years by working with other companies to plug the gap with ramped-up production. And PhRMA, the industry group for brand-name drugmakers, said manufacturers have stepped up their voluntary reporting of events that might lead to drug shortages.

“The executive order does not grant us new authority beyond what the legislation on the books has already done,” Health and Human Services Secretary Kathleen Sebelius told reporters on a conference call. “What it does do from the presidential level is commit increased attention on this, and a multi-department focus.”

The order does allow the FDA to more broadly interpret one provision of existing legislation that could let it force certain companies to report a shortage: if they are the only maker of that drug and it is life-saving.

Norman Ornstein of the American Enterprise Institute said Obama’s use of executive powers may signal a significant change in the administration’s approach to governing.

He said the White House may instruct all cabinet departments and agencies to find issues of public need that could be addressed in similar fashion.

“Executive action doesn’t always have the force of law and lacks the power of the purse that come unambiguously with congressional action,” he said. “(But) it’s been clear since November 2010 that getting much out of Congress - even in areas where there’s a broad consensus - would be like pulling impacted wisdom teeth.

“So your choice is to turn to executive action. The only thing surprising is that it took him as long as it did,” said Ornstein.

The FDA and the broader HHS department on Monday released separate reports on the drug shortage problem.

“There is no single or simple solution that can resolve the medical product shortage problem,” the FDA report said.

The reports encouraged companies to boost their drug production. Some drugmakers have already pledged to build new facilities and increase production, including Teva Pharmaceuticals and Hospira.

But the new capacity is unlikely to come on line for at least another 18 months, the FDA said. By law, the FDA is not allowed to force companies to continue making drugs that are in shortage.

The FDA said three companies were involved in 40 percent of the 127 shortages it studied in depth because of their duration and public health impact over the past two years.

Dan Rosenberg, spokesman for specialty drug maker Hospira, said the company supports the order to broaden reporting of shortages and address gouging.

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By Anna Yukhananov and Deborah Charles

WASHINGTON