Stopping Drug Shortages

Pharmaceutical companies are under pressure to notify the Food & Drug Administration earlier and more often about expected prescription drug shortages, after President Barack Obama signed an executive order on Oct. 31 urging such compliance. The order stops short, however, of a mandatory reporting requirement for the drug industry.

The action was welcomed by medical societies, the pharmaceutical industry, and other stakeholders as a step toward minimizing drug shortages in the U.S.

But some people are questioning whether industry will follow through without a legal requirement. “Manufacturers have demonstrated that, absent regulatory or legislative requirements, they will not consistently and voluntarily share information with FDA,” the Endocrine Society said in a statement.

The executive order more than doubles the number of FDA staff devoted to drug shortages and requires FDA to expedite regulatory reviews of new manufacturing sites, suppliers, and changes in manufacturing practices associated with drugs that are in short supply. It also calls on FDA to work with the Department of Justice “to examine whether ‘gray market’ profiteers are responding to potential drug shortages either by hoarding medication or charging exorbitant prices,” Kathleen Sebelius, secretary of the Department of Health & Human Services, said at an Oct. 31 briefing.

The Obama Administration is leaving it up to Congress to provide FDA with the authority needed to put teeth into the order. At the signing of the directive, Obama urged lawmakers to pass H.R. 2245 and S. 296, legislation that would give FDA the ability to require and enforce reporting of all potential drug shortages.

For now, drug manufacturers are required to notify FDA before they stop the production of a critical drug only if they are the sole provider. If more than one company makes the drug, such reporting is voluntary.

The pharmaceutical industry has pledged to do what it can to stop drug shortages, which have primarily affected generic injectable drugs, including cancer treatments, antibiotics, and anesthetics.