Democrats and Republicans on the House Energy and Commerce Committee appear no closer to resolving differences around prescription drug shortages after a legislative hearing in the Health Subcommittee on Thursday.
The debate is entangled in a stalled reauthorization of a pandemic and emergency preparedness law that expires Sept. 30.
The U.S. is facing an ongoing shortage of critical medications for conditions like cancer, which recently prompted the Food and Drug Administration to loosen import restrictions for cisplatin, a generic chemotherapy drug. Fourteen other cancer drugs remain in short supply, the White House Office of Science and Technology Policy said Sept. 12.
The panel examined five bills, including a wide-ranging draft bill from committee Chair Cathy McMorris Rodgers, R-Wash., that would exclude certain injectable generic drugs from pricing penalties and mandatory discount programs, among other things.
Lawmakers also debated three Democratic bills that would increase reporting requirements when drugmakers are hit with unexpected demand, increase reporting around the source of active pharmaceutical ingredients and require drugmakers to study the longest possible expiration date of their medications.
But there’s no sign that Rodgers plans to incorporate any of the Democratic bills into her legislation, although she said in an interview Wednesday that she was “open to all ideas.”
“I do not believe FDA authorities would solve these issues,” she said, “and in some cases, I think FDA may play a role in worsening a shortage through unclear communication.”
The GOP draft focuses on the economics underpinning low-margin generic drug production, while the Democratic bills aim for more industry oversight by the FDA. The Republican bill also weakens programs that Democrats champion, like the drug discount program 340B and mandatory government rebates when drugmakers raise their prices faster than inflation.
“I oppose many of the policies in the Republican discussion draft because I simply do not believe they will help end the drug shortage crisis,” Energy and Commerce ranking member Frank Pallone Jr., D-N.J., said. “In fact, I think they will make it worse.”
Republicans pointed to repeated comments from FDA Commissioner Robert Califf that economic circumstances don’t properly encourage generic drug production as justification for their bill.
“We all want cheaper drug prices,” said Health Subcommittee Chair Brett Guthrie, R-Ky. “But we also want access to the drugs that are needed.”
But Guthrie also dismissed industry concerns about the draft bill’s potential administrative burden, after Healthcare Supply Chain Association President and CEO Todd Ebert requested the committee nix transparency reporting requirements for hospitals and group purchasing organizations.
“We wouldn’t be here if your system is working,” Guthrie said.
While prices do contribute to shortages, Yale School of Medicine and Law School postdoctoral fellow Melissa Barber testified, drugmakers sometimes abuse the argument. She pointed to a 2016 court ruling in Italy that found Aspen Pharmacare plotted to destroy cancer drugs in order to drive up prices.
“Price is a factor,” she said, “but it’s not the be-all, end-all.”
The government also lacks insight into reasons behind more than half of drug shortages because of incomplete reporting, she added.
Democrats are still angling to include their bills in a final package, but it’s unclear if that will be enough to earn their support.
Health Subcommittee ranking member Anna G. Eshoo, D-Calif., said she plans to introduce another bill in the coming days that will require hospitals to maintain a six-month “buffer stock” of pediatric cancer drugs, modeling a strategy used by Civic Rx, a nonprofit generic drug company that says it has successfully weathered the current market shortages for its members.
But she also chided Republicans for attempting to exclude drugs from federal pricing restrictions, calling the bill “a grab-bag of talking points.”
One area of concern for Democrats is excluding certain generics from the 340B drug discount program, which requires drugmakers to offer steep discounts to certain types of hospitals, including those that serve a disproportionate share of low-income patients.
Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said he hasn’t found a link between 340B and drug shortages. And while the drugs in shortage make up less than 1 percent in 340B price savings, he said, it would hit certain hospitals hard.
“Our hospitals and health systems that are providing care for underserved patients would notice that,” he said.
Timing for a subcommittee markup is not yet clear.