FDA Moves to Stem Drug Shortages

The FDA is exploring ways to prevent long-term drug shortages and allow more drug importation so patients have access to medically necessary drugs.

The agency is setting up a work group to explore policy frameworks that would allow for increased drug importation of “medically important” medications. This would address challenges when the drug suddenly becomes unavailable from the sole manufacturer or there are significant price increases in the medication.

“Any policy that involves the importation of drugs would be temporary until adequate competition enters these categories. Furthermore, any resulting policy would also be narrowly tailored in order not to create the same risks of counterfeits or other unsafe drugs getting into the U.S. supply chain as a broader importation policy would present,” said FDA Commissioner Scott Gottlieb, MD, in a statement.

The agency’s ultimate goal is to seek multiple FDA-approved and marketed versions of each medically important drug for which there are no blocking patents or other exclusivities, Gottlieb added.

The agency also formed a Drug Shortages Task Force, which will be led by Keagan Lenihan, FDA’s associate commissioner for strategic initiatives. “I’m charging the shortages task force to delve more deeply into the reasons why some shortages remain a persistent challenge. The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages,” Gottlieb said in a statement.

Many of the drugs in short supply, historically, are low-profit margin generic medicines. "Many are sterile, parenteral drugs, which can be challenging to manufacture. The low-profit margins, and the significant cost of manufacturing these complex drugs, has resulted in consolidation in the industry. The only way to produce these low-margin products profitably is to manufacture them at tremendous scale. This has resulted in fewer and fewer manufacturers for certain key products,” Gottlieb said.

As a result, long-term solutions must encourage companies to invest in increased capacity to make these important medicines, “and to produce them with robust manufacturing processes that ensure consistently available quality products,” Gottlieb said. “This is one area we’ll explore. But we also need to look more broadly across the entire pharmaceutical industry, health care providers, payers and government regulators for structural solutions that keep these shortages from happening.”

The Drug Shortages Task Force will include leaders from the Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs, which collectively “provide or pay for prescription medicine for millions of Americans,” Gottlieb said.