Medicare Rx Benefit Data Could Help FDA Identify Drug-Safety Issues

Electronic data collected by the Centers for Medicare & Medicaid Services (CMS) under the Medicare prescription drug benefit could help the FDA more quickly identify drug-safety problems and assist drugmakers in lowering the costs of Phase IV studies, the head of the CMS said.

The new drug benefit and its accompanying technology provides an unprecedented opportunity to develop better evidence about a drug's safety profile, according to CMS Administrator Mark McClellan.

The CMS plans to use an electronic prescribing system to gather data on drugs covered under Medicare Part D, which will account for approximately 40 percent of all prescriptions filled in the U.S., McClellan told a symposium on drug safety held by the Pharmaceutical Care Management Association.

Starting next year, the CMS will collect 36 data points on each Part D drug, including information on the product's form and dosage, and whether patients refilled their prescriptions. "This will be the largest collection of data on prescription drugs," McClellan said. The new data will be combined with existing healthcare data gathered on Medicare beneficiaries to provide insights on drug usage and health outcomes, he noted.

The CMS could work with the FDA to develop a type of "Red Flag" system on drug-safety issues, he said. The system, however, would not likely replace the FDA's current voluntary Adverse Events Reporting System (AERS), McClellan added. "The more comprehensive types of information we can get on adverse events and drug benefits, the better," he said. "I wouldn't view this as a replacement of AERS. I would certainly view it as an additional source of information and evidence."