FDA OKs cancer drug imports to allay domestic shortage
Agency issues draft guidance on shortages
Topics: Oncology, Service Lines, Medication Administration, Quality, Performance Improvement
February 22, 2012
FDA on Tuesday announced that it temporarily will allow the importation of alternatives for Doxil and methotrexate, two cancer drugs that have been in short supply since November, the New York Times reports.
FDA will permit the importation of Sun Pharma Global's Lipodox to address the shortage of Johnson & Johnson's Doxil, a drug that is used in multiple regimens, including treatment for certain ovarian cancers. It also approved APP Pharmaceuticals to import preservative-free methotrexate, which is used to treat children's leukemia. Hospira also is delivering 31,000 vials of methotrexate from an Australian plant to the U.S.
Medical experts praised the agency's move but noted the need for more permanent solutions, the Wall Street Journal reports. According to Michael Link, president of the American Society of Clinical Oncology, "FDA, our pharmacists, physicians, and manufacturers have cobbled together patches, but we cannot continue to practice medicine from crisis to crisis."
FDA issues draft guidance for shortages
FDA on Tuesday released draft guidance outlining both mandatory and voluntary notifications from drugmakers when they foresee issues that could disrupt supply.
The guidance builds on an executive order by President Obama in October that gave federal regulators more authority in tracking shortages, approving replacement manufacturing sites, and punishing price gougers.
"The draft guidance clearly describes for industry how, what, when, and why they should notify the FDA of an issue that could lead to a product shortage or a disruption in supply," FDA Commissioner Margaret Hamburg said. Hamburg said the agency has seen a 600% increase in reporting since the voluntary reporting initiative was launched last year (Harris, Times, 2/21; Corbett Dooren, Journal, 2/22; Daly, Modern Healthcare, 2/21 [subscription required]; Pecquet, "Healthwatch," The Hill, 2/21).
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