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FDA Moves to Avert Drug Shortages

New actions aim to help the agency respond to quality control issues that force drugmakers to discard medicines



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Patients relying on lifesaving therapies for emergency care and cancer have long-suffered from stops and starts in drug manufacturing. The vexing problem is not going away, but the U.S. Food and Drug Administration today rolled out new plans designed to help stymie the shortages.

The action is good news for patients relying on some oncology drugs, antibiotics, liquid nutrition and anesthetics—all areas that have suffered from shortages in recent years.

Under a new proposed rule the FDA would require companies to notify it in advance of any plans to halt production of certain prescription drugs in short supply or of any manufacturing disruptions that could cause temporary shortages of those medications. With a bit more notice, the FDA says, it could better stave off shortages. The FDA’s new requirements would also extend to medically important “biologic” drugs—products composed of sugars, protein or nucleic acids that are typically made from living microorganisms. Shortages of biologics, including a class called sterile injectable drugs, can endanger patients and compromise care.

Shortages of both drugs and biologics most frequently stem from poor quality control during manufacturing. Crystals growing in supposedly sterile drug vials can prompt a pause in production and leave hospitals and pharmacies scrambling to find drug alternatives while companies prowl for back-up facilities. Sterile injectables, which are complex to produce because their sterility must be maintained at all times, are typically made in small batches and have few backup options. And overall, drug shortage issues, including those with biologics, skyrocketed in the last decade, prompting White House and congressional action. In 2005 six drug shortages were reported to the FDA, but by 2010, shortages had nearly tripled to 178, with three quarters of the shortages comprising injectable drugs.

The FDA’s new actions on drug shortages came in response to a 2011 executive order from Pres. Barack Obama as well as a 2012 law that ordered the FDA to take another look at the problem of drug shortages and improve the agency’s response. The law, the 2012 FDA Safety and Innovation Act, also gave the agency the legal power to require drug manufacturers to notify it of potential supply disruptions. And in the past couple years the situation has improved: Since the executive order there has been a sixfold increase in notifications to the FDA about possible shortages. The agency says it helped avert 195 drug shortages in 2011 and 282 in 2012.

The FDA’s new blueprints for change today include creating a new federal notification rule and releasing a long-term strategic plan (required under law and produced by an FDA task force). “There are really very few issues that frustrate me more than when we come across a situation where a drug is in shortage,” FDA Commissioner Margaret Hamburg told reporters during an October 31 press briefing. The agency’s long-term strategic plan includes launching a new smartphone app that would give information about drug shortages and set in motion some FDA internal housekeeping to improve its in-house and external communications about drug shortages.

Any decisions about assigning metrics like letter grades to drugs—a step floated by FDA personnel in the past to indicate the quality of different manufacturers and pressure companies to improve—was not part of the plan. “We have not made a decision there but that is something we are looking into,” says Douglas Throckmorton, deputy director of regulatory programs at the FDA’s Center for Drug Evaluation and Research.

New drug shortages roughly halved from 2011 to 2012, dropping from 251 to 117. But although the rate of new shortages slowed, problems still persist with chronic shortages in specific areas. An “alarmingly” high level of shortages continue to exist across oncology, according to the American Society of Clinical Oncology. The group says shortages of electrolyte solutions and intravenous drugs continue to plague cancer care.

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