Monday, December 9, 2013

FDA Creates Plan To Combat Drug Shortages

Over the past few years, the FDA has made significant strides in the prevention of drug shortages, circumventing 200 shortages in 2011 and more than 280 in 2012. By the end of December 2012, however, 300 drugs remained in short supply. In October, the FDA outlined a plan to mitigate ongoing drug shortages while averting future supply problems.

“Preventing drug shortages before they begin is a top priority for the FDA,” said FDA Commissioner Margaret A. Hamburg, MD, during a media briefing on Oct. 31. “Drug shortages pose a significant public health threat because they can result in serious, or even deadly, outcomes.”

Although the FDA currently prevents a large number of shortages each year, the scarcities are occurring at higher frequencies than a decade ago. There were about 60 new drug shortages in 2005, according to the FDA. By 2011, the number of new shortages had increased to more than 250. In response, Washington took two actions that would provide the impetus for the FDA’s newest plan: an executive order issued by President Barack Obama in 2011 and the passage of the FDA Safety and Innovation Act (FDASIA) in 2012, which gave more muscle to the agency’s regulatory capabilities.
At the heart of the FDA’s new strategy are improved lines of communication, with respect to both drug manufacturers and the public. In the short term, the agency plans to streamline its internal response whenever a manufacturer gives notice about a supply problem. Through a proposed rule, any company that produces “medically necessary” drugs must alert the FDA about a discontinuance or interruption in the production of a drug. That way, the agency will be able to provide information about drug shortages to the public. “It might help individual purchasers make plans for the future,” said William L. Greene, PharmD, the chief pharmaceutical officer of St. Jude Children’s Research Hospital, in Memphis, Tenn. “If [the FDA] can update that information quickly, that would probably be a benefit.”

A potential hitch, however, could be a discrepancy between what the FDA considers a shortage and a hospital pharmacist’s definition. “If premixed heparin bags are in short supply, it can be tremendously difficult for hospital pharmacies,” said Erin R. Fox, PharmD, the director of the Drug Information Service at University of Utah Health Care, in Salt Lake City. “The FDA may not see that as a true shortage.” Patients have been harmed when hospitals mix heparin improperly, Dr. Fox said.
Health-system pharmacists seeking information about drug shortages have two primary options: a list of shortages and other resources maintained by the American Society of Health-System Pharmacists (, and a drug shortages database maintained by the FDA ( “ I tend to not use the FDA database as frequently as I use the [ASHP] database,” Dr. Greene said. “There’s more information that’s more meaningful to me there.”

As part of a long-term approach, the FDA laid out plans to tackle the underlying cause of shortages. “The majority of drug shortages, an estimated 70%, are the result of a breakdown in quality and manufacturing,” Dr. Hamburg said. Under some life-threatening circumstances, the FDA will exercise regulatory discretion as a temporary fix to quality issues. When rubber particles were discovered in Genentech’s Cathflo Activase (alteplase) in March 2013, for example, the FDA allowed the drug to be distributed with a warning that it must be filtered before administration.
But such regulatory discretion is not sufficient when drugs are contaminated with bacteria and fungus, or when the production of a drug has been halted. An estimated 30% of U.S. drug-manufacturing capacity is currently offline as a result of FDA actions, Dr. Fox noted.

“We cannot solve the challenges of drug shortages alone,” said Douglas Throckmorton, MD, the deputy director of the FDA’s Center for Drug Evaluation and Research. He called for a greater emphasis on the quality and stability of the drug supply.

“As the FDA has indicated, the current supply chain does not reward manufacturers for quality,” Dr. Greene said. Although the FDA is limited in what it can accomplish, he said, the agency could help the marketplace make decisions that would reward manufacturers for quality. FDASIA asks the FDA to consider the creation of a qualified manufacturing partner program, which Dr. Greene called “a slam dunk” for purchasers. Under such a program, the price of medications may increase—but drug shortages also contribute to higher costs of medication, Dr. Greene said.

The FDA warned that pharmaceuticals purchased from the secondary gray market might worsen the effects of a shortage because these products may be improperly stored or handled. “It troubles me that we have people who are willing to purchase drugs from the gray market,” Dr. Greene said. “I just can’t believe we actually do that.”

Dr. Fox said the University of Utah made a decision in 2001 to prohibit the purchase of drugs from the gray market. “If no one was buying from the gray market,” she said, “it wouldn’t exist.”
Dr. Fox said she is “hopeful” that the FDA’s methods will prioritize manufacturing quality. “What’s evident in the plan is the tremendous amount of work the FDA has done. Kudos to them for doing what they can.”

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