The letter was sent to four House and Senate negotiators who are working on legislation to reauthorize the Food and Drug Administration's user-fee programs.
The bill, which would reauthorize user-fee programs for the drug and device industries, as well as authorize the first generic drug and biosimilar user fees, also includes other measures, such as one in the Senate bill that would create a unique device identification system.
Cummings launched an investigation into secondary drug distributors last year after hearing reports that distributors were marking up the prices of drugs in short supply.
“We encourage you to consider whether legislative proposals to modify the current federal law on pharmaceutical supply chain security would adequately address the risk we have identified in our investigation,” Cummings and Rockefeller said in the letter.
They said the investigation has raised concerns about whether drugs bought and sold by distributors are being handled properly through the supply chain and that their staffs have used paper pedigrees mandated by pedigree laws about 30 states to help identify the fraudulent or unsafe business practices of secondary drug distributors.
“We understand the great value in assigning each manufactured drug a unique identifier, but this step alone does not ensure that consumers, regulators and industry stakeholders know who has owned a drug or how the drug has been handled,” the lawmakers said in the letter.