FDA seeks heads-up on drug shortages

The FDA’s Janet Woodcock said early warnings would help the agency work with companies to resolve supply problems.
Brendan McDermid/REUTERS 2011 Files
The FDA’s Janet Woodcock said early warnings would help the agency work with companies to resolve supply problems.

WASHINGTON — The Food and Drug Administration announced a new proposal Thursday to try and head off more shortages of crucial medications that have disrupted care at hospitals and clinics nationwide.

Under the proposed rule, companies that make medically important prescription medicines would have to notify the FDA six months ahead of any changes that could disrupt the US supply. That includes plans to discontinue a product or manufacturing changes that could slow production.

‘‘The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders,’’ the FDA’s top drug regulator, Dr. Janet Woodcock, said in a statement.


FDA leaders say advance warnings help the agency work with companies to resolve supply problems or find alternate producers for drugs that are being phased out. The FDA credits earlier warnings from companies with reducing the number of drug shortages from 251 in 2011 to 117 last year.

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Drug shortages in the United States have spiked over the past six years, particularly those involving inexpensive generic injected drugs, including powerful antibiotics, painkillers, and anesthetics used in surgery. They are the workhorses of hospitals but are difficult to make and produce little profit for drug makers.

Some cancer drugs also have been in short supply, disrupting treatments that require medication administered on a precise schedule.

The FDA proposal expands and strengthens existing requirements passed by Congress last year and an executive order issued by President Obama in 2011. Those measures require drug makers who are the sole manufacturer of a drug to contact the agency ahead of any supply disruptions. Thursday’s proposal would expand the requirement to any company making a drug that is ‘‘life supporting, life sustaining’’ or used to treat a ‘‘debilitating disease or condition.’’ The FDA plan would also expand the requirement to nondrug biologic products, such as vaccines.

Penalties against companies that do not comply would not be very severe. FDA officials said Thursday that the agency will post on its website ‘‘non-compliance’’ letters to companies that fail to provide enough advance notice.


The forces behind recent drug shortages include consolidation of generic drug manufacturers, as well as manufacturers deciding to end production of marginally profitable drugs. Many shortages are also caused by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories.