Once Again...Congress Fails to Agree on National Pedigree Law

Today, Medscape Pharmacists News reported that lawmakers at the US federal level did no agree on a national plan for tracking medications. Medscape stated that failure to come to an agreement is "crimping efforts to protect the U.S. Supply chain from the threat of counterfeit or stolen drugs".

After a last minute effort over last weekend to work out the details of the plan, the Senate and House of Representatives "conceded defeat in trying to include the measure in a 'must-pass' funding bill for the FDA.

The article went on to state that many stakeholders, including regulatory agencies and private companies have been working on a 'track and trace' system for about 10 years, but no agreement can be made as to how the plan will work or who will pay for it.

Congressional staffers have been quoted as stating that some lawmakers may try to introduce the measure as a stand-alone bill later this year, but this was also tried in the last Presidential election cycle in 2008. That bill (HR5839) failed to make it out of committee. This year, we have a divided Congress, which will make it even tougher in 2012.

The Senate version of this current FDA bill required a uniform "drug tracing system". But a newer draft was proposed last Friday that lawmakers could not get agreement on "how quickly the U.S. would move toward a 'unit-level' system that tracks individual drug packages". The timeline was very long, and it was not clear if it would ever even happen. Hence, the measure died.

The article mentioned the California Pedigree law which was passed in 2004, appeared in the 2005 California Pharmacy Law Book and whose first phase is currently scheduled to be implemented in 2015, after multiple delays.

Access Pharmacy Resources CA Designated Rep Seminar instructor, Greg Evans, Pharm.D., started teaching these California laws when the legislation was making its way through the CA legislative bodies in 2004. If you need the most current information on CA Pedigree laws, contact us here at APR and we can give you everything you need.

Stay tuned...our ear is always close to the ground.