FDA Announcement

FDA has taken steps to boost the supply of two critical cancer drugs—Doxil and methotrexate—both of which have been facing nationwide shortages.

FDA will temporarily allow importation of the unapproved drug Lipo-Dox, from India-based Sun Pharma, as a replacement for Doxil, FDA Commissioner Margaret A. Hamburg announced on Feb. 21. FDA has also fast-tracked the approval of preservative-free methotrexate from APP Pharmaceuticals, and the agency is working with other companies to ramp up production of methotrexate, Hamburg said.

FDA’s latest actions add to a growing list of measures the agency has taken since President Barack Obama signed an executive order last October to alleviate the growing problem of drug shortages in the U.S. Those measures include developing a database to track drug shortages, sharing information with the Justice Department to address stockpiling of drugs and exorbitant pricing, and collaborating with industry and other stakeholders.

There has been a sixfold increase in the number of firms voluntarily notifying FDA of potential drug shortages since the executive order. Despite the increase, FDA fully supports legislation, H.R. 2245 and S. 296, that would require manufacturers to report all drug shortages to the agency and would give it enforcement authority.

“We know that advanced notification works. But to truly be most effective, Congress must grant FDA the authority it needs to require notification for all lifesaving drugs,” Rep. Diana L. DeGette (D-Colo.), sponsor of H.R. 2245, said in a statement. “And manufacturers that do not comply should be penalized for putting patients at risk.”