Drug Shortages Remain ‘Serious Concern,’ FDA Deputy Says

By Jeannie Baumann

Drug shortages remain a serious concern at the FDA as challenges persist, the agency’s deputy commissioner for legislation and policy said June 6.

“It’s a serious concern not just in routine, everyday clinical care, but also in the context of a shortage of life-saving products at a time of a public health emergency,” Anna Abram, deputy commissioner for policy, planning, legislation, and analysis for the Food and Drug Administration, told a House panel.

An FDA database includes more than 100 products that are in shortage, including penicillin and Avadel Pharmaceuticals’ ephedrine, which is often used to prevent low blood pressure during spinal anesthesia.

The FDA’s drug center can encourage drug manufacturers to build in capacity when producing drugs, but the agency can’t require it, Abram said. The FDA also has worked to help import products to supplement drug shortages.

“It’s a continual challenge,” she said.

Rep. Richard Hudson (R-N.C.) said physicians, hospital representatives, and other health-care providers have expressed concerns these drug shortages will leave them unequipped to respond to a massive public health emergency.

“Every time there’s a disaster or infectious disease outbreak, I hear from my constituents at home,” he said. “I believe these drug shortages hamstring our ability to properly respond.”

Pandemic Reauthorization Hearing

Hudson made his remarks about drug shortages during the House Energy and Commerce health subcommittee hearing on health security programs within the Department of Health and Human Services.

“Infectious diseases are a mere plane ride away and we must continue to assure we are prepared and we’re able to respond,” Rep. Michael C. Burgess (R-Texas), chairman of the health subcommittee, said in his opening statement.

The June 6 hearing was the first step on the House side to reauthorize programs under the Pandemic and All-Hazards Preparedness Act (PAHPA), which in part develop, purchase, and maintain medical countermeasures to respond to a major outbreak of a disease. These programs will expire Sept. 30 without a new law.

“We will move forward expeditiously,” Energy and Commerce Chairman Greg Walden (R-Ore.) said. “We realize there’s a deadline ahead for reauthorization.”

Stockpile Transfer Questions

While the Senate health committee already approved its version of the bill May 23, the House bill is still in draft form and has some wrinkles to iron out.

There are concerns about a proposal in the House version to transfer management of the national stockpile of countermeasures from the Centers for Disease Control and Prevention to the assistant secretary of preparedness and response.

“We must make certain that placing the SNS [strategic national stockpile] in ASPR instead of CDC does not weaken our current preparedness and response capabilities before making such a move permanent,” Rep. Frank Pallone Jr. (D-N.J.), the top Democrat on Energy and Commerce, said.

Rep. Susan W. Brooks (R-Ind.), the lead Republican on the bill, said the contracting and management of the stockpile would move to ASPR but both agencies would continue to work with state and local officials to coordinate distribution.

“The stockpile is not moving anywhere. It’s going to remain with the CDC. There’s an administrative shift from CDC to ASPR,” Rep. Anna G. Eshoo (D-Calif.), the lead Democrat on the bill, said later in the hearing.

Brooks told Bloomberg Law the debate over the stockpile underscores how critical it is for these agencies to have the best biodefense and hazard preparedness efforts possible.

“This is a draft bill that we have, and we’re trying to figure out how to provide those guardrails that we’ve heard about to make sure that if the Strategic National Stockpile moves, CDC still has a critical role and what that role is,” Brooks said.

Burgess told Bloomberg Law after the hearing he expects the bill will go through markup both by the subcommittee and the full committee, “So there’ll be plenty of opportunity to move things around.”