Congress Approves FDA Bill Containing RFID Provisions
Last Thursday, the US Congress approved new legislation concerning the Food and Drug Administration and passed it on to President Bush for ratification. The FDA bill included among other things, provisions that tasked various industry segments and department of government with ensuring effective tracking standards for pharmaceutical products. The bill’s language includes the following:
“The Secretary shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.
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The Secretary shall, in consultation with the agencies specified [above], manufacturers, distributors, pharmacies, and other supply chain stakeholders, prioritize and develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.
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Not later than 30 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall develop a standardized numerical identifier (which, to the extent practicable, shall be harmonized with international consensus standards for such an identifier) to be applied to a prescription drug at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing) at the package or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription drug.
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The standards developed under this subsection shall address promising technologies, which may include—
(A) radio frequency identification technology;
(B) nanotechnology;
(C) encryption technologies; and
(D) other track-and-trace or authentication technologies.
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In carrying out this subsection, the Secretary shall consult with Federal health and security agencies, including—
(A) the Department of Justice;
(B) the Department of Homeland Security;
(C) the Department of Commerce; and
(D) other appropriate Federal and State agencies.”
More information about HR 3580 can be found on THOMAS
The language is so ambiguous that it is impossible to interpret the intended outcome.
"at the package or pallet level" - OR? Did they mean 'and' or is pallet tracking sufficient to meet this amendment? Do they know how long a manufacturer pallet survives before it is resorted?
The "Promising Technologies" paragraph where they mention RFID says it may also consider "other track-and-trace or authentication technologies." Essentially suggesting the Secretary should look at ALL technologies. Or not.
And does anyone know the purpose of this Reagan-Udall Foundation? The foundation can acquire patents they think are important to the FDA - and license them to industry! So, they are a regulatory agency with a direct role in approving technologies or drugs they essentially own. I just wonder if they want to get into the RFID business. A few swats of the imminent domain ruler and we may lose some important patents.