Published: August 1st, 2013
As Congress adjourns this week for its traditional August recess, matters of urgent concern to the pharmaceutical industry—national traceability legislation and proposed electronic labeling—have yet to be resolved.
The timeline for a traceability law slowed somewhat last week in the Senate when the Health, Education, Labor, and Pensions Committee (HELP) called back its proposed bill for amending.
Yet S. 959, The Pharmaceutical Quality and Accountability Act—into which a separate act designed to crack down on pharmacy compounding is folded-- was then “hotlined’ this week in the Senate. Hot lining is process in which members are requested to allow a bill to be approved by the Senate without debate or amendment.
“Senate leadership is in the process of determining what amendments, opposition, or other issues exist at this point. It appears highly unlikely that the bill will be on the floor this week, due to unresolved issues related to compounding, so we are looking at September for floor activity at the earliest,” said one supply chain source.
The Senate and House will have to reconcile two bills with considerable differences when Congress comes back into session next month.
The latest HELP committee amendments include one notable change: manufacturers four years after enactment are required to provide transaction information in electronic form, Dirk Rodgers reports in his RxTrace blog.
The HELP bill has required manufacturers to affix the standard numerial identifier (SNI) to unit level packaging four years after enactment, with supply chain deployment of interoperable electronic tracing of product at the package level after ten years.
The Pharmaceutical Distribution Security Alliance, the supply chain coalition lobbying for preemptive federal legislation, has expressed confidence the committees can narrow their differences in short order.
“PDSA is optimistic the bill will make its way to the President’s desk in September. We have no sense of opposition in the Senate and see differences between the two bills as being highly bridgeable,” PDSA said in a statement this week.
Yet supporters of the Senate’s approach –which clearly mandates unit level traceability—are opposing the House bill—endorsed by the full House of Representatives in May—as far too weak.
The Senate bill establishes a unit level traceability system in ten years through self-effecting statute, meaning FDA would not have to create new regulations to implement it, says Allan Coukell, senior director of drugs and medical devices, The Pew Charitable Trusts.
The House bill directs FDA to create proposed regulations on an enhanced system no earlier than 2027, with no requirement for a final rule, Coukell says.
“The main difference between the Senate and House bills is certainty and timing. The Senate provides certainty that a unit level system will be established in ten years. The House requires only proposed regulations no earlier than 2027,” Coukell says.
While the Senate bill combines two bills on traceability and compounding, the House bill includes a provision on electronic labeling absent in the Senate bill. The measure that would allow manufacturers to provide the professional package insert exclusively in electronic form is being opposed by the Pharmaceutical Printed Literature Association.
PPLA last week praised a report issued by the Government Accountability Office on drug e-labeling that it says validates industry concerns: e-labeling will impact patient safety, and largely destroy the specialty printing industry.
As with the anxiously anticipated track and trace legislation, industry will have to wait a while longer to see the outcome of the House’s push for e-labeling.
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