Bipartisan Bill To Address Chemotherapy, Other Drug Shortages
20 Junho 2011 - 7:19PM
Dow Jones News
Lawmakers will introduce a bipartisan bill in the U.S. House
Tuesday designed to help the Food and Drug Administration address
worsening shortages of chemotherapy and other lifesaving drugs.
The legislation, sponsored by Reps. Tom Rooney (R., Fla.) and
Diana DeGette (D., Colo.), will require companies to notify the FDA
of problems that might result in a drug shortage such as a
manufacturing problem or trouble getting a raw ingredient, similar
to a bill pending in the U.S. Senate. The House measure, however,
would subject companies to fines of up to $10,000 per day, with a
cap of $1.8 million, for failure to comply with reporting
requirements.
The FDA reported a record 178 drug shortages in 2010, versus 157
the year earlier and 55 five years ago. The shortages included
certain chemotherapy drugs used to treat cancer, intravenous
antibiotics to treat infections, nutritional drugs for patients who
can't eat and other drugs used in hospital intensive-care units.
Although the agency doesn't have figures for 2011, the FDA said the
shortages "have continued at a rapid pace" so far this year.
The problem grew so severe in April that major cancer hospitals
started to ration supplies of a leukemia drug called cytarabine
after two of the drug's three manufacturers had production
problems. Doctors have been substituting chemotherapy drugs for
many breast-cancer patients.
The shortages are growing more severe in part because of
industry consolidation that means many injectable generic drugs are
now made by one or two companies such as Teva Pharmaceutical
Industries Ltd. (TEVA, TEVA.TV) or Hospira Inc. (HSP). When one
company runs into a manufacturing problem with a product or decides
to quit making a drug, competing companies can't quickly fill the
void.
"The earlier [that] doctors, suppliers and the FDA are able to
communicate a potential drug shortage, the better equipped they are
to respond and possibly prevent a disruption from occurring,"
Rooney said. The measure will also allow the FDA to post letters
from companies informing the FDA of potential or actual shortages
in order to give hospital pharmacists a better gauge of how long a
particular shortage might last.
Current law requires companies to report to the FDA in cases
where they are the only supplier of a drug and they plan to quit
making it.
The FDA has said 38 shortages were prevented in 2010 from
companies who voluntarily gave the agency early notification of a
problem with a drug. In some cases, the advanced warning gave the
FDA time to work with competing manufacturers to ramp up production
to avert a shortage.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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