The U.S. House on Monday passed a bill would require drugs be electronically tracked through the distribution system, but critics say it's too weak.
H.R. 1919, the Safeguarding America's Pharmaceuticals Act, aims to crack down on stolen and counterfeit drugs, as well as the re-entry of adulterated drugs into the supply chain, according to MedPage Today.
It passed on a voice vote, with no recorded vote taken.
The bill, however, stops short of requiring unit-level traceability--and there can be thousands in a manufacturing lot. And that's where counterfeiting takes place, according to the MedPage article.
The bill calls only for an "enhanced" system by 2027, with no requirement for final rules or implementation. Once rules are finalized, it would be another two years before they could go into effect.
Allan Coukell, deputy director of medical programs at the Pew Charitable Trusts, told MedPage Today that the House bill has zero chance of passing the Senate. Meanwhile, a Senate bill, due for a floor vote later this month, requires a move to unit-level traceability after 10 years. Either of the bills would supersede state-crafted legislation to track pharmaceuticals.
The U.S. Food and Drug Administration supports unit-level traceability, and 29 medical and patient advocacy organizations, including the American Society of Clinical Oncology and the American Public Health Association came out against the House bill.
An Institute of Medicine report published in February calls for a public database similar to that proposed in the Senate bill. That legislation calls for the entire supply chain--from manufacturers to dispensers--to electronically provide transaction information during changes in ownership providing more real-time information.
Meanwhile, Orange Healthcare, the health division of French telecommunications company France-Telecom Orange, has developed a text-based platform that authenticates drugs digitally. The SMS-based solution, to be used in Africa, includes a unique verification code, which is hidden behind a scratchable surface layer, on each packet or bottle of medicine. Patients then can submit the code via text message to check the authenticity of the drug against a database.
To learn more:
- read the bill
- here's the MedPage Today article