Executive order targets critical drug shortages

President Obama took unilateral action Monday to help stem the
nation’s shortage of lifesaving drugs, a level of personal involvement
in health policy not seen since passage of the healthcare law almost 20
months ago.

Tied to the slogan “We can’t wait,” Obama
has been rolling out a series of executive orders to show he’s doing
everything he can to help the economy despite the impasse in Congress
over his jobs bill.

{mosads}The latest presidential action
ensured a moment of positive coverage on the healthcare front after a
difficult stretch that saw the demise of the long-term care program and
the release of a poll that found most Americans disapproving of the
reform law.

Republicans dismissed the president’s executive order
as too little, too late. The Republican National Committee said Obama
ignored “years of headlines warning about drug shortages” and “finally
decide[d] to look like he’s doing something for political expediency.”

But
not everyone in the GOP was critical. Some Republicans even praised the
president for urging passage of bipartisan drugs legislation that’s
been stuck in both chambers of Congress.

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“I’ve heard from patients
and doctors in my district and nationwide who are experiencing limited,
and sometimes zero, access to life-saving drugs, from commonly used
anesthetics to cancer therapies,” Rep. Tom Rooney (R-Fla.) said in a
statement. “I’m very pleased that President Obama is addressing this
critical issue and supporting our bipartisan bill.”

In June,
Rooney introduced legislation with Rep. Diana DeGette (D-Colo.) that
would require drugmakers to report to the Food and Drug Administration
(FDA) shortages of numerous drugs. A similar effort in the Senate
championed by Sen. Amy Klobuchar (D-Minn.) has 17 co-sponsors, including
Republican Susan Collins of Maine.

Patient advocacy groups and the pharmaceutical industry also responded favorably to Obama’s executive action.

The
Generic Pharmaceutical Association applauded the order and urged
collaboration between industry and government. The Pharmaceutical
Research and Manufacturers of America said it “echoes a priority of
America’s biopharmaceutical research companies — the well-being of
patients and their ability to access life —saving prescription
medications.”

And the American Cancer Society Cancer Action Network called it an “essential step to address the growing drug shortage crisis.”

“The
drug shortage crisis is making it difficult or impossible for some
cancer patients to get the medications they have been prescribed,”
network President Christopher Hansen said in a statement. “On behalf of
people with cancer and their families nationwide, ACS CAN commends the
president for taking action.”

The new executive order gives
federal regulators more power to track drug shortages, quickly approve
replacement manufacturing sites and punish price gougers. The
administration simultaneously increased staffing at the FDA’s Drug
Shortages Program, sent a letter urging drugmakers to voluntarily
disclose more potential prescription drug shortages and released two new
reports on the underlying causes of shortages and the FDA’s role in
preventing them.

Efforts announced Monday “will give us extra time
to work with the industry to prevent, reduce or mitigate the shortage,”
Health and Human Services Secretary Kathleen Sebelius told reporters on
a conference call.

“While we can’t control all the factors that
cause the shortages — starting with the fact that demand is outpacing
supply — there are steps we can take,” she said. “We can work with
manufacturers to fix quality issues. We can work with other firms to
increase production. And [the new order] will lead to earlier FDA
notification of any impending shortages of certain prescription drugs.”

Critics
of the executive order said it would not be effective because it does
not eliminate artificially low federal reimbursements in certain
government health programs.

“President Obama is not responding to
the real cause of the problem, which is price controls,” said health
economist Devon Herrick of the free-market National Center for Policy
Analysis.

Several factors have been blamed for the shortages,
including manufacturing decisions, drug industry consolidation,
stockpiling, shortages of raw materials and FDA regulations that critics
say make the drug approval process slow and cumbersome. 

But the
administration released new reports Monday blaming industry
shortcomings, rather than heavy-handed regulations, for the shortages
that affected a record 211 drugs last year — three times more than in
2005.

“An important factor in many of the recent shortages appears
to be an increase in demand that exceeds current manufacturing
capacity,” Obama wrote in his order. “While manufacturers are in the
process of expanding capacity, one important step is ensuring that the
FDA and the public receive adequate advance notice of shortages whenever
possible.”

Shortages of medicines, including lifesaving
antibiotics and cancer drugs, are on track to top last year’s record. As
of mid-October, the FDA had identified shortages of 82 medicines, based
on voluntary self-reporting by manufacturers. But a national expert at
the University of Utah who tracks national drug shortages told NPR that
the real number is 213.

The shortages are putting patients in
danger: Eighty-two percent of hospitals reported that drug shortages
have caused treatment delays, according to a recent survey by the
American Hospital Association, and more than half were not always able
to provide the patient with the recommended treatment.

“Three out
of four hospitals report rationing or implementing restrictions for
drugs that are in short supply,” the July 2011 report said.

Sebelius
said the agency has helped stave off 137 shortages over the past 21
months but that the president wants FDA to redouble its efforts.