FDA seeks advance drug shortage alerts
WASHINGTON — The Food and Drug Administration announced a new proposal on Thursday to try heading 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 before any changes that could disrupt the supply. The rule would include plans to discontinue a product or any 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 Dr. Janet Woodcock, FDA's top drug regulator, in a statement.
Agency 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 have increased during the past six years, particularly those involving inexpensive generic injected drugs — powerful antibiotics, painkillers and anesthetics used in surgery. The drugs are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers.
Some cancer drugs 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. The measures require pharmaceuticals that are the sole manufacturer of a drug to contact the agency ahead of any supply disruptions. The new 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 expand the requirement to non-drug biologic products, such as vaccines.
Penalties against companies that don't comply would not be very severe. FDA officials said the agency will post on its website “non-compliance” letters to companies that fail to provide enough advance notice.