By Megan R. Wilson - 05/15/13 06:51 PM EDT
Lawmakers voted down an amendment from Rep. Frank Pallone (D-N.J.) that would have required the development and implementation of an electronic unit-level tracking system for drugs within 10 years. The system would not allow criminals to insert fake medications into the supply system because each individual prescription would have a marker.
“We all know the perils of rule making in general,” Pallone said, pointing to the food safety legislation Congress passed, and President Obama signed, in 2011. The FDA just recently proposed rules to carry out those laws.
Republicans said Pallone’s amendment would have circumvented the Administrative Procedures Act, which governs the rulemaking process, while burdening smaller pharmacies.
Rep. Marsha Blackburn (R-Tenn.) voted against Pallone’s amendment because she said it put “bureaucrats at the FDA over the job creators at small pharmacies.”
“The bill is written so that everyone in the supply chain process has a seat at the table,” she said.
Rep. Jan Schakowsky (D-Ill.) noted that the Senate is working on a draft of a similar bill that includes the substance of the Pallone amendment with the backing of industry groups.
“This is not about the FDA, this is about consumers,” Schakowsky said. “FDA bureaucracy. That just rolls off the tongue. But we're talking about industry experts and stakeholders.”
Industry groups support the general direction of the legislation, including unit-level tracing systems, if they are put in place properly.
The National Association of Chain Drug Stores told The Hill it has not specifically endorsed any of the bills currently moving through Congress, but the group "is supportive of moving the process forward and working carefully on the details."
“We put a man on the moon in 1969, that's eight years after President Kennedy said it would happen,” said Rep. Eliot Engel (D-N.Y.), adding, “I don't know why we would set a 16-plus year” timeline on the individual drug-tracking rules.
Before a meeting last month with stakeholders and Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, Rep. Fred Upton (R-Mich.), the chairman of the House Energy and Commerce Committee, committed to do “all that I can” to get the law signed by President Obama by the August recess.
Electronic records that track drugs through the complex distribution system from manufacturer to clinics and hospitals would be a “tremendous tool” to help thwart ineffective or dangerous counterfeit medications from reaching consumers, Woodcock said during last month’s meeting.
--- This post was amended at 5:30 p.m.