U.S. Senator Tom Coburn, M.D. (R-OK) today released the following statement concerning the passage of S. 1082, the Prescription Drug User Fee Amendments of 2007. The bill reauthorizes the Food and Drug Administration (FDA) and provides critical mechanisms to limit the risks from prescription drugs to ensure patient safety.
Dr. Coburn, along with Senators Judd Gregg (R-N.H.) and Richard Burr (R-N.C.), added a provision to S. 1082 establishing a surveillance system to track the adverse effects of prescription drugs.
"I thank my Senate colleagues for working with me to address my concerns to ensure this legislation gives patients access to potentially life-saving drugs that might not otherwise be approved because of known adverse events caused by the drug," Dr. Coburn said. "As a practicing physician, I know it's impossible to completely eliminate drug risks. The right approach is to provide accurate risk information and preserve the doctor-patient relationship. It is critical that in addressing drug safety that we do not harm access to new and life-saving medical technologies."
The legislation also contains a provision (section 252) added by Dr. Coburn which would apply FDA regulations and fines to those who sell "medical marijuana." Because marijuana has not been approved by the FDA for any medical use, drug dealers who promote or advertise marijuana for medical use could be fined as much as $150,000 for a first offense and $300,000 for additional false advertising offenses. In addition, those who sell marijuana for unapproved medical uses would be subject to FDA fines as high as $2 million for non-compliance with FDA statutory requirements set by this bill.