On May 17, the House Energy and Commerce Committee approved its version of the prescription-drug tracking bill, HR 1919, “by voice vote Wednesday, the Senate Health, Education, Labor and Pensions Committee will mark up” its version, S 957, on May 22. Both bills aim to “move to an interoperable, electronic, unit-level tracing system throughout the drug supply chain,” but they differ in terms of how fast they would transition from lot-level tracking to the unit level. The Senate’s bill would “transition to a unit-level tracing system over 10 years, with the Food and Drug Administration conducting pilot projects and holding public meetings for comment on moving toward the interoperable, electronic, unit-level system.” In contrast, the House’s measure “would establish national standards for a lot-level tracing system and create a process” for the FDA and supply chain stakeholders to work together, but the agency would not have to propose any regulations until 2027. The Energy and Commerce Chair Fred Upton (R-MI) has vowed to get the bill to Obama by the August recess.
Well, it's good to know there's some movement afoot since May 8, when bipartisan legislation gave federal regulators the power to track individual medications. (As a side note: At Shamrock Medical we currently are developing a system for e-pedigree for tracking at the lot-level, which is a requirement for VAWD accreditation.)
Essentially, the bill is designed to close loopholes in the supply chain and aim to prevent counterfeit drugs from reaching consumers, thus preventing harm to patients. It's also supposed to ensure that overlapping red tape does not impose dramatic costs on patients in the form of higher prescription drug costs or potential drug shortages.
I've read about squabbling among party lines already, such as, the regulatory framework will take too long to implement, as the bill will not require regulations from the FDA until 2027, and grumblings in the House that the burden that these new requirements may place on small pharmacies.
Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research summarized the situation accurately when she stated, "Criminals are getting more sophisticated at copying drug labels and profiting from putting counterfeit medications in the $300 billion U.S. prescription drug market (and) if we don't know the chain of custody of a product... if we have to reconstruct that later, through questioning people, that could cause great delays..." (in recalling the product or finding out where the problem occurs).
The sad truth is, in recent years very little has passed through a divisively bipartisan government. What are your feeling about this bill seeing the light of day?
Here's to better solutions,
Dave Bystrom
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