translation agency

Agence France-Presse
US to import short-supply cancer drug from India

February 21, 2012

WASHINGTON, Feb 21, 2012 (AFP) - US health authorities said Tuesday they
will import a drug to treat ovarian, bone marrow and AIDS-related skin cancer
from India in order to ward off a worrying shortage.

"Lipodox will be imported as an alternative to Doxil," the US Food and Drug
Administration said in a statement, noting that a temporary deal has been made
with Sun Pharma Global FZE in India to supply US patients with the drug.

"Temporary importation of unapproved foreign drugs is considered in rare
cases when there is a shortage of an approved drug that is critical to
patients and the shortage cannot be resolved in a timely fashion with
FDA-approved drugs."

Another drug that has been in short supply, methotrexate -- needed for
treating a variety of cancers including children with leukemia -- was approved
in preservative-free generic form for maker APP Pharmaceuticals in Illinois
and should be available by March, the FDA said.

In the meantime, a shipment of 31,000 vials, or one month's supply, is
being sent right away to hundreds of US hospitals and treatment centers by
Hospira, the agency added.

Prescription drug shortages in the United States nearly tripled from 2005
to 2010, according to the Department of Health and Human Services.

Many drugs are falling out of production because drugmakers cannot profit
when medications go generic and carry extremely low price tags.
Profit-incentive for doctors to prescribe more expensive cancer meds has also
contributed to the problem.

In October 2011, US President Barack Obama signed an executive order
directing action to head off shortages in life-saving prescription drugs.

Obama's order strengthened the FDA's power to predict and tackle potential
shortages of prescription drugs and to halt illegal price gouging of
life-saving medicines during supply shortfalls.

Since then, the FDA has been able to ward off 114 drug shortages, compared
to a total of 195 drug shortages prevented in 2011, the agency said.

The change is mostly due to a six-fold increase in companies complying with
a request to give early warning to the FDA if they foresee a shortage, so that
health authorities can seek other suppliers.

The FDA on Tuesday also "issued draft guidance to industry on detailed
requirements for both mandatory and voluntary notifications to the agency of
issues that could result in a drug shortage or supply disruption," it said.

"A drug shortage can be a frightening prospect for patients and President
Obama made it clear that preventing these shortages from happening is a top
priority of his administration," said FDA Commissioner Margaret Hamburg.

"Through the collaborative work of FDA, industry, and other stakeholders,
patients and families waiting for these products or anxious about their
availability should now be able to get the medication they need."




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