FDA Announces Effort To Address Shortages of Two Cancer Treatments

On Tuesday, FDA 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.

The shortages of both treatments began after Ben Venue Laboratories temporarily closed an Ohio plant to address product safety concerns (Harris, New York Times, 2/21).

FDA will allow 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 (Corbett Dooren, Wall Street Journal, 2/22). Hospira also is delivering 31,000 vials of methotrexate from an Australian plant to the U.S.

Reaction

Medical experts praised the agency's move but noted the need for more permanent solutions, the Journal reports.

Michael Link, president of the American Society of Clinical Oncology, said, "FDA, our pharmacists, physicians and manufacturers have cobbled together patches, but we cannot continue to practice medicine from crisis to crisis" (Wall Street Journal, 2/22).

Peter Adamson, chair of the Children's Oncology Group, said that "this is at best a Band-Aid approach to the problem." Adamson called on FDA to create an advisory committee from several medical disciplines to assess the most problematic shortages. "Children are at such risk from drugs in short supply that it doesn't give me a whole lot of comfort that we've moved past one or two of these shortages," Adamson said (New York Times, 2/21).

FDA Issues Draft Guidance for Shortages

Also on Tuesday, FDA released draft guidance outlining both mandatory and voluntary notifications from drugmakers when they foresee issues that could disrupt supply, Modern Healthcare reports (Daly, Modern Healthcare, 2/21).

The guidance builds on an executive order by President Obama in October 2011 that gave federal regulators more authority in tracking shortages, approving replacement manufacturing sites and punishing price gougers (Pecquet, "Healthwatch," The Hill, 2/21).

FDA Commissioner Margaret Hamburg said, "The draft guidance clearly describes for industry how, what, when and why they should notify the FDA of an issue that could lead to a product shortage or a disruption in supply." Hamburg added that the agency has seen a 600% increase in reporting since the voluntary reporting initiative was launched last year (Modern Healthcare, 2/21).