Hearing explores prescription drug shortages

Rep. Michael Burgess (R-Texas) highlighted the impact of prescription drug shortages on the medical community during a hearing on Monday.

Burgess, the vice chairman of the House Energy and Commerce Subcommittee on Health, outlined the FDA’s role in addressing shortages, steps taken to avert backorders and how limited availability of prescription drugs impacts the ability of doctors to treat patients.

“Physicians are still faced with having to tell patients that they cannot receive the care they need not because there is no treatment, but because a product is simply not available,” Burgess, a licensed physician, said.

Generic drug lines operate on tight margins so production stalls when companies can’t afford to revamp machinery and backorders occur, Burgess said.

“FDA has a role in addressing drug shortages, but this is a complex and serious issue,” Burgess said. “In 2010, more than 240 drugs were in short supply or were unavailable, and more than 400 generic equivalents were backordered.”

The Food and Drug Administration Safety and Innovation Act was signed into law in 2012. Committee leaders like Burgess and House Energy and Commerce Committee Chairman Rep. Fred Upton (R-Mich.) worked together on its provisions.

The bill gave the FDA authority to collect user fees to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar products. It also aimed to promote innovation and stakeholder engagement.

FDASIA has helped address the problem of prescription shortages, Burgess said, but the problem has not gone away.