WASHINGTON – Sen. Chuck Grassley and Sen. Dianne Feinstein, the leaders of the Caucus on International Narcotics Control, today announced the caucus will hold a hearing on the quota system used to manage controlled substances in medicine in light of a new report from the Government Accountability Office (GAO) showing problems in the way the program is managed.
“The quota system has to work well because it serves two important purposes,” Grassley said. “It restricts controlled substances to prevent illicit use and addiction. It also manages the availability of controlled substance for medical use, including surgery. The government agencies involved haven’t been working well together to meet these two goals. The GAO report and the hearing will help the agencies and Congress fix the management problems that are getting in the way of achieving both quota system goals.”
Feinstein said, “The controlled substances quota process determines how much of a certain drug a manufacturer can produce. Today’s GAO report shows that the quota process is not being managed effectively and there is a lack of communication between DEA and FDA. Mismanagement of the process may harm health care providers and patients and I hope the upcoming Drug Caucus hearing will shed light on the causes of these problems and offer effective solutions.”
The GAO report found that the Drug Enforcement Administration (DEA), which is responsible for setting quotas for manufacturing controlled substances, does not have a collaborative relationship with the Food and Drug Administration (FDA), which regulates medical drug safety, among other management shortcomings. The report makes recommendations to improve the management. Medical experts have complained of shortages of medically necessary drugs over the management problems.
The hearing is planned for Tuesday, April 14, 2015. Witnesses are expected to include a representative of the DEA, the FDA and the GAO. A witness list and other details will be released at a later date.
The Government Accountability Office report is available here. Grassley and Sen. Sheldon Whitehouse requested the report.