FDA: Ending drug shortages all about timing

By Jack Moore
Federal News Radio

A recent Executive Order signed by President Barack Obama requires the Food and Drug Administration to get out in front of critical drug shortages.

The order requires the agency to issue earlier warnings of impending shortages.

It’s not necessarily a new problem. The FDA identified problems with drug shortages as early as 1999, which led to the creation of the Drug Shortage Program.


However, the shortages are escalating.

Hospitals have also reported price-gouging because of low drug supplies. And often the drugs in short supply are the ones most needed to treat critical illnesses and diseases: chemotherapy drugs, anesthetics and saline bags used for intensive care feeding. Fifteen deaths nationwide, so far, have been traced to drug shortages.

Peter Lurie, a senior adviser in the Office of the Commissioner at the FDA, told the Federal Drive with Tom Temin and Amy Morris how the executive order will change how the FDA operates.

The FDA already has authority to tackle drug shortages. In rare cases, Lurie said, FDA will actually import depleted drugs. However, more commonly, the agency works “constructively and creatively” with the drug companies that manufacture them to head off shortages. This require cooperation between government and industry, Lurie said, as well as speeding up the inspection process, if necessary.

The executive order essentially asks the agency to do more of the same, he explained.

Under current law, certain drug makers are required to notify the FDA six months before an impending shortage. FDA recently penned a letter to pharmaceutical companies reminding them of their notification responsibilities and asking them to contact the agency even sooner, if possible.

“The sooner we hear (of a shortage), the sooner we can act,” Lurie said.

The next step in drug-shortage regulations could actually be legislation, Lurie said.

“Hand in hand with the executive order … is impending legislation that would accomplish many of the same things, but with the actual force of law,” he said.

For example, new legislation would require companies to notify the government of all drug shortages — not just those deemed “medically necessary,” such as cancer drugs. A new law would also allow FDA to fine companies that don’t comply with shortage notifications.

But Lurie said FDA isn’t just waiting around for Congress to act.

“We are going to take this on, because we understand it to be an important problem,” he said. In fact, just this week, the agency announced plans to double the Drug Shortage Program’s staff.