Experts Worry Controlled Substances Bills Could Stifle Research

Thomas Cosgrove spoke at the Energy & Commerce health subcommittee hearing to discuss bills that would amend the CSA with a goal to stem the opioid crisis and is quoted in an FDA Week article. According to Cosgrove, "Virtually all manufacturers of 'solid oral' drugs in the United States use tableting or encapsulating machines in some form," including prescription, nonprescription and animal drugs; dietary supplements; and over-the-counter products. "Furthermore, tableting machines are often used in the manufacture of candy, cosmetics, and certain household products such as cleaning agents. The collective dollar value of these product sales in the United States is enormous and people use them every day," said Cosgrove.

Cosgrove added that the bill would require manufacturers to store machines in secured areas, such as steel cages, safes, or vaults; dispose or replace malfunctioning machines by transferring them to companies specifically registered by DEA to render the machines "non-retrievable;" and comply with recordkeeping and paperwork requirements each time a machine is moved between locations. "Such requirements if enacted would greatly increase regulatory burdens for domestic manufacturers and make everyday products less available to consumers," he said. "FDA inspects manufacturing facilities to ensure that equipment such as tableting machines are operating within the scope of Current Good Manufacturing Practices under applicable law and regulations. FDA does not, however, require registration of individual pieces of equipment. Drug, dietary supplement, and other manufacturers have a great deal of flexibility in selecting or changing out the equipment they use, which flexibility could disappear if this bill were enacted as drafted," Cosgrove explained.