FDA would create electronic drug-tracking system under legislation

Federal legislators this week unveiled a bill that calls on the U.S. Food and Drug Administration to develop an electronic system for tracking pharmaceuticals "from manufacturing to distribution."

The bill--known as the Drug Quality and Security Act--initially was unveiled in April as a draft bill by Sens. Michael Bennet (D-Colo.), Richard Burr (R-N.C.), Tom Harkin (D-Iowa) and Lamar Alexander (R-Tenn.). It is meant to replace the current "patchwork of state prescription-drug tracing laws" by creating a national uniform framework.

"Plain and simple, this legislation will help ensure that providers and their patients have access to high-quality compounded drugs," Harkin said in a statement. "This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards."

The legislation, according to Alexander, was crafted, in part, as a response to a meningitis outbreak to a 2012 meningitis outbreak that caused 58 deaths and more than 700 sick individuals. The outbreak occurred after a Massachusetts compounding pharmacy produced tainted steroids.

"The FDA commissioner has warned us that an outbreak like this will happen again if we don't clarify oversight, so I have worked hard with my colleagues in the House and Senate to make it clear at every compounding facility who's on the flagpole--who's in charge--of overseeing their compounding practices," Alexander said in a statement.

Lawmakers and the governor in Pennsylvania are backing creation of a database of prescriptions for habit-forming drugs. The state already has a prescription-monitoring database, but it's limited to powerful painkillers including Fentanyl, Oxycodone and Percocet.

Missouri remains the only state that has not at least passed legislation to create a prescription-monitoring program. Yet experts say "doctor shopping" for painkillers remains a daily problem largely because those monitoring programs don't carry tough consequences for inappropriate prescribers.

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