Obama To Press FDA On Drug Shortages; Will Support Legislation
31 Outubro 2011 - 11:45AM
Dow Jones News
President Barack Obama will announce his support for legislation
aimed at helping the U.S. Food and Drug Administration address a
shortage of chemotherapy and other critical care drugs, according
to an administration official.
Obama will also sign an executive order Monday directing the FDA
to take action "to help further reduce and prevent drug shortages,"
said the official, although it is not immediately clear the
specific steps the agency is being asked to take.
Bills introduced in the House and Senate would require companies
to notify the FDA when they have a problem that could result in a
shortage. Current law requires companies to report to the FDA in
cases when they are the only supplier of a drug and they plan to
stop making it.
The Food and Drug Administration reported a record 178 drug
shortages in 2010 and has said there is a greater number of
shortages so far this year. Most of the shortages involve older,
generic drugs administered by injection or intravenously. Along
with cancer drugs they also include antibiotics to treat infections
and nutritional drugs for patients who can't eat.
Most of the drugs are generic, not highly profitable and are now
made by only one or two companies. Teva Pharmaceutical Industries
Ltd. (TEVA) and Hospira Inc. (HSP) are two of the bigger producers
of generic drugs.
The shortages are growing more severe, in part, because of
industry consolidation and manufacturing problems in the past year.
When one company runs into a manufacturing problem with a product
or decides to stop making a drug, competing companies can't quickly
fill the void.
Production at a Hospira plant in North Carolina has been slowed
down in recent months as the company works to fix a variety of
manufacturing problems. In April, Teva reopened a California plant
that it had shut down voluntarily for about a year, in part to
retool to meet FDA manufacturing guidelines.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
--Jared A. Favole contributed to this article.
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