The deep divisions in U.S. politics have been more apparent than ever this week, but there was also evidence everyone can pull together. Both Houses of Congress and political parties got behind a bill to set a 10-year deadline for a track-and-trace system that has database implications for drugmakers.
Widespread support for the bill--which was only introduced on Sept. 25--allowed it to win approval in the House of Representatives after just 40 minutes of debate. The bill is now awaiting a hearing in the Senate, where it already has supporters among Democrats and Republicans. If approved by the Senate and signed into law by President Obama, the bill will override state-level track-and-track plans, and set a 10-year deadline for adoption, SecuringIndustry reports.
Having a nationwide law would free biopharma of the data and software problems that arise from each state having its own standards. Oracle ($ORCL) is among the companies to introduce serialization management software, but the need to add different requirements for each state complicates the task. Under the bill introduced late last month, biopharma companies would need to create a database to keep track of their products. The database would allow biopharma to comply with requirements of the legislation, which gives companies 24 hours to respond to questions about a drug's authenticity.
One database could cover all of a company's activities in the U.S., and the legislation specifically calls for a public meeting on data interoperability. The meeting would lead to a guidance document setting out standards for secure data exchange among different players in the drug supply chain. A format developed by a widely recognized international standards development organization is expected.
The bill has received the backing of BIO, PhRMA and other organizations. "We support the establishment of strong, uniform, scalable national standards for drug serialization and tracing systems contained in this legislation, rather than relying on the emerging patchwork of individual state mandates," BIO said.
- read the SecuringIndustry article
- here's the bill (PDF)
- check out the press release
- here's more from FiercePharmaManufacturing