FDA moves to help prevent drug shortages

WASHINGTON, Feb. 21 (UPI) -- The U.S. Food and Drug Administration moved forward to increase the supply of critical cancer drugs and to help prevent future shortages, officials 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," Dr. Margaret A. Hamburg, FDA commissioner, said in a statement. "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."

Due to the critical shortage of the cancer drug Doxil -- doxorubicin hydrochloride liposome injection -- there will be temporary importation of a replacement drug, Lipodox -- doxorubicin hydrochloride liposome injection -- which is expected to end the shortage and fully meet patient needs in the coming weeks.

For methotrexate, in addition to already announced actions, the FDA approved a new manufacturer of preservative-free formulation of methotrexate that is expected to further bolster supply and help avert a shortage of this lifesaving medicine, Hamburg said.

The actions build on Obama's executive order addressing prescription drug shortages last October. Today the FDA issued draft guidance to industry on detailed requirements for both mandatory and voluntary notifications to the agency of issues that could result in a drug shortage or supply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, officials said.

Since the executive order, the FDA headed off 114 drug shortages, officials said.