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FDA Details Drug Shortage Rules

WASHINGTON (CN) - The Federal Drug Administration has proposed new regulations that aim to keep pace with the demand for critical medications during shortages caused by discontinuances and interruptions in manufacturing.

"Information from the FDA's drug and biological product shortages databases shows the number of drug and biological product shortages quadrupled from approximately 61 in 2005, to more than 250 shortages in 2011," according to the action.

Under the new regulations, manufacturers would be required to notify the FDA 6 months before any changes in the supply of "medically important" prescription drugs, including their permanent discontinuation or temporary manufacturing interruptions. In cases where advanced notice is not possible, manufacturers would be expected to report issues no later than five business days after the discontinuation or interruption, the FDA said in its action.

Medically necessary drugs are those used to treat or prevent a serious disease or medical condition for which there is no alternative medicine available in adequate supply.

Those drugs include a "prescription product that is life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery," the FDA said.

The regulations would also apply to medically important biological products, such as blood or blood components for transfusions.

The FDA worked with manufacturers and other stakeholders to prevent another 200 shortages from occurring in 2011, and decreased the number to 117 in 2012, the agency said in its action.

Shortages are still a problem, especially considering they can involve drugs used to treat cancer, to provide required parenteral nutrition (intravenous feeding), or to address other serious conditions, the FDA said. Shortages can result in treatment delays or denial of needed care for patients, and can also result in prescriptions for alternatives that may not be as effective or come with higher risks, according to the action.

"The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages. 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 Director of the FDA's Center for Drug Evaluation and Research, Dr. Janet Woodcock, in a statement.

Early notification of drug shortages gives the FDA time to work with manufacturers to investigate issues leading to manufacturing disruption, to identify other manufacturers who can make up all or part of the shortfall, and speed up inspections and reviews of submissions from manufacturers of drugs that may prevent or mitigate a shortage, according to an FDA statement.

In addition, the proposed regulations would require the FDA to maintain a current list of, and information about, drugs that are determined by the FDA to be in shortage in the U.S.

The shortages involve quality/manufacturing issues, delays in receiving raw materials and components from suppliers, or discontinuation of certain drugs altogether, according to the FDA's statement.

"The FDA can't require a firm to keep making a drug it wants to discontinue. Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs. With fewer firms making older sterile injectable drugs, there are a limited number of production lines that can make these drugs. The raw material suppliers the firms use are also limited in the amount they can make due to capacity issues at their facilities," the agency said.

The problem, in part, lies with manufacturers when they decide to quit making a drug, leaving other manufacturers with the task of meeting continued demand.

For example, "the small number of manufacturers and limited production capacity for older sterile injectables, combined with the long lead times and complexity of the manufacturing process for injectable drugs, results in these drugs being vulnerable to shortage. When one company has a problem or discontinues, it is difficult for the remaining firms to increase production quickly and a shortage occurs," the FDA said in its statement.

Comments are due by Jan. 3, 2014.

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