Traverse City Record-Eagle

Life

November 2, 2013

Companies asked to head off shortages

WASHINGTON (AP) — 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 U.S. 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,” said FDA’s top drug regulator Dr. Janet Woodcock, 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.

Drug shortages in the U.S. 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 drugmakers.

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 drugmakers 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 non-drug biologic products, such as vaccines.

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