Senate Drug Manufacturing Transparency Bill Watered Down
A bipartisan Senate bill intended to give patients and health care providers more information about where prescription drugs are manufactured has lost two provisions that drug safety experts considered important to making the new disclosure requirements effective, according to ProPublica. The bill, the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, would mandate country-of-origin labeling for both finished prescription drugs and the active pharmaceutical ingredients, or APIs, used to make them. Current federal labeling rules do not require public disclosure of the countries where APIs or finished products are manufactured, Scott says.
The legislation, sponsored by Sens. Rick Scott (R-FL) and Kirsten Gillibrand (D-NY), cleared the Senate HELP Committee in July on a 21-1 vote and is awaiting consideration by the full Senate.
Scott said the lack of labeling leaves patients, pharmacists, and health care providers with limited visibility into the origins of many commonly used medicines. Many generic drugs and APIs are produced outside the U.S., particularly in China and India, according to the senator.
The proposal builds on work Scott has led as chairman of the Senate Special Committee on Aging, including an investigative report and multiple inquiries to federal agencies and pharmaceutical companies examining U.S. reliance on foreign-manufactured generic drugs. Scott has also framed the measure as a way to reduce U.S. dependence on foreign drug manufacturing and encourage domestic production.
ProPublica reported that the legislation originally would have required labels to include a unique facility identifier that could be used to link a drug to a specific manufacturing facility and, in some cases, FDA inspection records associated with that plant. That requirement has been removed. The revised bill also extends implementation of the labeling requirements to five years after enactment, rather than allowing them to take effect as early as one year afterward.
People familiar with the negotiations told ProPublica that some lawmakers were concerned the original requirements could increase drug costs and create national security concerns by disclosing precise locations where critical medicines are manufactured.
Critics contend the changes could substantially reduce the legislation's usefulness. Former FDA investigator Peter Baker told ProPublica that eliminating the unique facility identifier could make enforcement more complicated because inspectors would have to determine whether the addresses provided by manufacturers accurately identify production facilities.
Another potential issue is the bill's use of the term “place of business.” Experts interviewed by ProPublica questioned whether manufacturers could satisfy that requirement by listing a corporate headquarters or other business location rather than the plant where a drug was actually manufactured. People familiar with the negotiations said they do not expect the language to create such a loophole and noted that FDA ultimately would determine what constitutes an acceptable address under implementing regulations.
No date has been scheduled for a Senate floor vote.