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House passes pharmaceutical tracking bill
June 17th, 2013
WASHINGTON – A federal system to track and trace prescription drugs moved a step closer to becoming reality earlier this month when the House of Representatives approved the Safeguarding America’s Pharmaceuticals Act of 2013.
Members of the House, who passed the measure on a voice vote, and industry advocates say the creation of a nationwide tracking system would help combat the spread of counterfeit drugs.
“After nearly a decade of working to create a federal traceability standard for pharmaceuticals, we are pleased by the House of Representatives vote to pass the Safeguarding America’s Pharmaceuticals Act of 2013,” Healthcare Distribution Management Association (HDMA) president and chief executive officer John Gray said the day that the law cleared the House. “Eliminating the cumbersome patchwork of state requirements is a bipartisan solution that will offer the clarity the industry needs to ensure medicines continue to be delivered safely and on time to the patients who need them.”
The measure must now be reconciled with a similar proposal pending in the Senate.
Gray said he hopes the two chambers can craft a final bill quickly and have it on the president’s desk by the end of July.
While the law passed in the House moves the creation of federal traceability closer to reality, critics of the measure say it does not go far enough. Some predict that the House version of the law has no chance of clearing the Senate.
The main objection to the House measure is that it does not set a specific time frame for the creation of an electronic tracing system.
The bill calls only for an “enhanced” system by 2027, with no requirement for final rules or implementation.
“By 2027, 14 years from now, the FDA [Food and Drug Administration] will be required to issue proposed regulations for such a system,” Rep. Henry Waxman (D., Calif.) told the Washington-based newspaper The Hill. “But there’s no requirement that these regulations ever be finalized, and if they are ever finalized, they cannot go into effect for at least two more years.”
Waxman says that a bill proposed in the Senate would require an electronic tracing system after 10 years, and said he hopes the House and Senate can eventually meet to approve a bill that is closer to the Senate version.
Meanwhile, other critics of the House bill say the bill is insufficient because it does not require unit-level traceability. A typical manufacturing lot, they say, can contain thousands of units, and that is where most counterfeiting occurs.
The FDA supports unit-level traceability, and 29 medical and patient advocacy organizations, including the American Society of Clinical Oncology and the American Public Health Association have come out against the House bill.