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Experts Say Drug Transparency Bill Has Been Stripped of Critical Provisions

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This story was originally published by ProPublica.

Landmark legislation designed to alert consumers to where their drugs were made is headed for a full Senate vote, but safety experts say the transparency bill has been stripped of two of its most critical provisions.

The Clear Labels Act was introduced earlier this year by Sens. Rick Scott, R-Fla., and Kirsten Gillibrand, D-N.Y., after lawmakers and drug safety experts called for more transparency in the industry. Last year, a ProPublica investigation revealed that the U.S. kept importing generic drugs from foreign factories after inspectors had identified quality and safety lapses at the sites, including leaks, mold and contaminated water.

Medications made at these facilities were linked to thousands of reported adverse reactions in patients.

The bill aims to allow doctors and patients to see on the label exactly where a medication was made — details that had largely been withheld until now, even from Congress. Current generic drug labels often include only the location of the packager or distributor, which can be thousands of miles away from the actual manufacturer.

One provision made the law particularly strong, experts said: The label was supposed to include a unique code that the Food and Drug Administration uses to identify factories. That code would have made it easier for researchers and the public to track the regulatory histories of specific facilities.

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The requirements also were supposed to take effect as early as a year after the bill’s passage.

Senators have now struck both of those provisions. People familiar with the deliberations said lawmakers worried the requirements would raise drug prices and weaken national security by revealing the precise locations where lifesaving medications are made.

The unique identifier requirement has been removed from the bill, and the timeline for companies to come into compliance was extended to five years.

“It’s just a clear watering down of the original bill,” said retired Army Col. Vic Suarez, a former medical supply-chain commander who has been leading a push for more domestic pharmaceutical manufacturing.

He and others also questioned why drug companies need multiple years to comply.

“Five years after it passes might as well be a lifetime,” said Dr. Kevin Schulman, a professor of medicine and health policy at........

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