By Anna Yukhananov and Deborah Charles
WASHINGTON |
Mon Oct 31, 2011 5:08pm EDT
WASHINGTON (Reuters) – U.S. 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 Republican foes and show voters he is serious about tackling the country’s problems ahead of a tough 2012 reelection campaign.
Obama instructed the U.S. 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.
The order reflects a proposed law on the shortages that has stalled in Congress, despite bipartisan support. In the meantime, doctors and patient advocates say drugs, such as some chemotherapy treatments, have become even scarcer, forcing providers to postpone care or use second-best or costly alternatives.
“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.
With his public approval ratings languishing near the 40-percent range over his economic stewardship and his re-election in jeopardy, Obama is trying to show voters he is ready to act on his own if Congress will not take action.
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.”
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.
“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.”
Norman Ornstein of the American Enterprise Institute said Obama’s use of executive powers may also 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 of the drugmakers have already pledged to build new facilities and increase production, but the “new capacity is unlikely to come on line for at least another 18 months,” the FDA said.
Dan Rosenberg, spokesman for specialty drug maker Hospira Inc, said the company supports the order to broaden reporting of shortages and address gouging.
“Hospira has agreements in place with distributors to actively police any of our products from getting into the gray market,” he said. Hospira is one of several manufacturers that have had manufacturing issues in the last few years, shuttering production on multiple drug lines. (Additional reporting by Caren Bohan, Matt Spetalnick, Alina Selyukh and David Morgan; Editing by Dave Zimmerman, Gunna Dickson and Tim Dobbyn)
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