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Ignoring pleas from PhRMA, the FDA has decided to stay the paper pedigree requirements in the Prescription Drug Marketing Act of 1987 (PDMA) for another 32 months while it oversees industry's adoption of electronic pedigrees using track-and-trace technologies to combat the counterfeiting of Rx drugs.
States looking to reduce drug costs in their healthcare programs would be better served by educating patients and providers about cheaper generic alternatives, instead of importing drugs from Canada, FDA Commissioner Mark McClellan said last week.
Even as the FDA urges industry to move toward electronic track-and-trace technologies as part of the agency’s campaign against counterfeit drugs, drugmakers and other interested parties are still trying to figure out how to do that — and what it would cost.
Counterfeiters are unlikely to target generic products because they are inexpensive and generate thin profit margins, according to generic manufacturers, who believe their drugs may not require the expensive anticounterfeiting technology recently recommended by the FDA.
Drugmakers will have to affix linear bar codes to the exterior labeling and interior unit-dose packaging of most prescription and certain OTC drug products commonly used in hospitals and other healthcare settings, under a new FDA final rule released last week.
In their zeal to import drugs from Canada, many states are overlooking existing means to reduce drug costs in their healthcare programs, including increased use of generics, FDA Commissioner Mark McClellan said yesterday.
Wisconsin joined Minnesota yesterday as a leading Rx drug reimportation proponent by expanding the state’s official website to include pricing data and ordering information for residents to buy prescription drugs from state-recommended Canadian pharmacies.
Drugmakers will have to affix linear bar codes to the labels of most of their prescription drug products under a new FDA regulation expected to cost the industry $28.1 million in the first two years of implementation, but projected to save the healthcare system billions of dollars in prevented medication errors.
The FDA will continue to stay paper pedigree requirements in the Prescription Drug Marketing Act of 1987 (PDMA) while it oversees industry’s adoption of electronic pedigrees using track-and-trace and other authentication technologies to thwart drug counterfeiting.