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FDA outlines plan to combat drug shortages

The Food and Drug Administration released a strategic plan for preventing drug shortages Thursday and proposed a rule to require drug and biotechnology companies to promptly notify the agency of potential disruptions to the supply of medically important drugs.

The plan and proposal come in response to a 2011 order from President Barack Obama to solve the problem of drug shortages. Between 2005 and 2011 the number of new shortages quadrupled to 251. That figure declined to 117 in 2012 but there were still more than 300 ongoing shortages at the end of the year.

The 2012 Food and Drug Administration Safety and Innovation Act called for the FDA to improve its response to imminent or existing drug shortages and to address the underlying causes. The act also gave the FDA new authority to require drug manufacturers to notify it of potential supply disruptions.

The FDA said its proposed rule would extend this early notification requirement to include makers of biologic drugs, which are typically complex products made from living organisms.

Most drug shortages are the result of quality control problems. The agency said it plans to work with manufacturers to fix such problems and "encourage" them to engage in practices that could avoid or mitigate shortages.

The FDA recommended that companies, among other things, design programs to ensure supply is available in the event of a shortage. It also recommended companies build up inventory before major manufacturing changes and communicate with contract manufacturers to anticipate problems.

Still, the agency said can only do so much to get companies to act, and suggested others think of ways to provide incentives for companies to improve their manufacturing processes.

"FDA is exploring ways to use its existing authorities to promote and sustain quality manufacturing," it said. "However, our ability to offer financial or other economic means to promote innovation in quality manufacturing is limited."

The FDA said groups that buy drugs, such as hospitals and group purchasing organizations, rarely take quality into account, and it recommended they examine publicly available information about a company's quality record.

"This decoupling of quality considerations from purchasing decisions makes cost the major factor in purchasing decisions," the FDA said, "most likely intensifying price competition, leading manufacturers to focus more on reducing costs than on maintaining quality."

The agency said it cannot require companies to build in extra manufacturing capacity to guard against shortages, or order a company to make a product if it is not profitable, but it invited "other stakeholders" to consider how to reward high manufacturing standards.

The FDA said that since the president's order there has been a six-fold increase in notifications about possible shortages. It said it helped prevent 195 drug shortages in 2011 and 282 drug shortages in 2012.