A Bill | Track and Trace

Senate Bill 957 Drug Supply Chain Security Act

Brian Rye

So your drugs aren’t doctored

212 IMAGES INC/CORBIS

The Essentials

1. The proliferation of counterfeit versions of drugs such as Lipitor and Avastin has lawmakers calling for the Food and Drug Administration to track and trace medicines electronically. Within 10 years, a medicine bottle would have a unique digital ID letting regulators follow its journey from manufacturer to pharmacy. To get federal licenses, wholesalers would have to do background checks on some employees and take their fingerprints.

2. The FDA likes the idea because it should help prevent tainted drugs from reaching consumers. Even though compliance would be costly, the drug industry prefers a national tracking system over a patchwork of state rules; California plans to implement its own version of track and trace in 2015 unless Washington acts. Yet the House and Senate disagree about how closely pills should be tracked. The House prefers to monitor bulk shipments instead of individual bottles.

3. The prospects for the Senate bill could also be complicated by the health committee’s recent decision to combine track-and-trace legislation with a bill that would give the FDA more oversight of the nation’s largest compounding pharmacies, which mix and sell medications and are licensed by states. Contamination at one such facility last fall caused 55 deaths. Republicans in the House are opposed to giving Washington more control of the pharmacies.

Vital Statistics

Co-authors:

Michael Bennet (D-Colo.)

Richard Burr (R-N.C.)

A bill with bipartisan backing

Co-sponsors:

Lamar Alexander (R-Tenn.)

Johnny Isakson (R-Ga.)

Tom Harkin (D-Iowa)

Section 1

p. 1, Title

Section 2

pp. 1-71, Pharmaceutical Distribution Supply Chain

Section 3

pp. 71-90

Enhanced Drug Distribution Security

The industry might fight its key provision requiring tracking of individual bottles rather than bulk shipments

Section 4

pp. 90-103

Section 5, pp. 104-113

Section 6, pp. 113-114

Sections 7 and 8, p. 114

Licensing standards for wholesalers and third-party logistics companies; penalties; amendments; savings clause

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