Prescription drug abuse, especially involving pain medicine, is a skyrocketing problem. Just this month, a new study showed that the number of pregnant women addicted to opiate drugs and the number of babies born with withdrawal symptoms have soared in the last 10 years. At the same time, prescription drug shortages of several kinds of drugs needed for medical treatment – including tranquilizers used to limit seizures and pain medicine for severe pain – are an ongoing problem.
More and more, emergency medical technicians report shortages of medicines they need in the field, and there are questions about whether attempts by the federal Drug Enforcement Administration to curb dangerous controlled substances are inadvertently contributing to shortages of these kinds of prescription medications.
To help sort through the questions, Senator Sheldon Whitehouse of Rhode Island and I have asked the independent Government Accountability Office to study the role of the Drug Enforcement Administration in drug shortages and recommend potential fixes.
The issue needs to be addressed in pending legislation to re-authorize the Prescription Drug User Fees Act, which provides funding to the Food and Drug Administration. The Drug Enforcement Administration’s role in drug manufacturing is separate from the Food and Drug Administration, so Senator Whitehouse and I are addressing the question on the Senate Judiciary Committee, where I serve as Ranking Member and Senator Whitehouse is a member.
The Drug Enforcement Administration sets quotas for drug companies that manufacture controlled substances and in effect limits how much product they are allowed to make. Since the drug shortage crisis developed, controlled substances are frequently on the drug shortage list of the Food and Drug Administration.
The Drug Enforcement Administration has to walk a fine line between managing dangerous controlled substances and making sure there are adequate supplies for legitimate medicine.
An independent assessment is needed to strike the right balance for everyone involved.
May 14, 2012