Regulatory Focus™ > News Articles > Hamburg Touts Agency's Efforts to Curb Drug Shortages

Hamburg Touts Agency's Efforts to Curb Drug Shortages

Posted 04 May 2012 | By

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said her agency has been remarkably successful in curbing drug shortages and working with industry to provide advanced warning when the agency is unable to prevent a shortage.

In a posting on the agency's FDA Voice blog, Hamburg said she is "both amazed and delighted to see the progress that's been made."

Hamburg noted advanced warning of shortages-thanks in part to an FDA rule asking manufacturers to provide such warnings to FDA when possible-has increased 600% in the past six months, while drug shortages have fallen more than 50%. Hamburg said the agency has worked to help prevent 128 shortages using a combination of additional resources, enforcement discretion and the foreign importation of drugs-some of which are unapproved.

But FDA's successes aren't cause for celebration just yet, remarked Hamburg.

"Drug shortages remain a serious, complex problem, and the agency remains extremely concerned about all current and potential drug shortages," Hamburg said.

Hamburg noted the agency is "working with Congress on bipartisan legislation to expand early notification of drug supply problems that could cause shortages," turning a now-voluntary program into one that could be mandatory.

"Drug manufacturers in particular have a responsibility to manufacture quality drugs and to have a process to ensure supply continuity of critical drugs," explained Hamburg.

Different parties have disputed the cause of the drug shortages, which reached record heights in 2011. Blame has been cast on manufacturers, the Centers for Medicare and Medicaid Services, FDA, low profit margins for generic drugs and quality issues for novel pharmaceuticals.

FDA staff, including the Deputy Director of the Office of New Drugs, Sandra Kweder, have in the past said drug shortages are likely to be persistent for "several years" as the pharmaceutical industry moves to increase manufacturing capacity.

"We don't have any expectation the issue will be resolved soon," Keweder said in a statement to the medical journal The Lancet in March 2012.

In the meantime, Hamburg has also noted her concern about the proliferation of counterfeit medications that are taking advantage of the drug shortage situation.

"As drugs are in shortage, it creates the possibility of new gray markets or illegal markets to fill in those gaps," said Hamburg in a 15 March interview on CNN.

Read more:

FDA Voice - Six Month Check-Up: FDA's Work on Drug Shortages

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