The Senate Health Education Labor and Pensions Committee has just voted unanimously to combine their current draft of “S. 957, Drug Supply Chain Security Act” with their current draft of “S. 959, Pharmaceutical Compounding Quality and Accountability Act” and pass the result onto the Senate floor for consideration. No amendments were offered in today’s session on either bill before the action. All committee members who spoke on behalf of both bills spoke very favorably about them. Now that the bills have been combined they will retain the number S. 959 if I understood the wording of the vote correctly.
This action, combined with the action in the House of Representatives last week (see “InBrief: A Track And Trace Bill Has Made It To The House Floor”), indicates that members of Congress now have a strong interest in passing a bill that increases the federal regulation of the pharmaceutical supply chain and that eliminates the patchwork of state laws (ehem…eliminates the California pedigree law), one way or another.
It is hard to imagine the Senate bill not passing the full Senate by a wide margin. The next question, however, is whether or not the full Senate will end up modifying the bill in any way during the floor debate, prior to the vote to pass. The same goes for the House version. For more on my thoughts between the House and Senate versions, see “An Industry Protection Bill Concealed Under The Veil Of Patient Protection”. Before either of these bills become a law the two houses will need to work together to come up with a single version. But that’s getting a little ahead of where things are right now. First things first. Let’s look forward to the debates on the House and Senate floors in the coming weeks/months.
Dirk.
Dirk, Thanks for this post.
From this and your earlier analysis on the draft, isn’t it realistic to conclude that serialization will largely be a individual company effort going forward – i.e.no mandate – and law or no law companies do implement some method or other to ensure the safety of their products, thereby protectng their brand. Can we extend this to say it is also a way companies can differentiate themselves (and get some pricing power) in the largely generics driven pharma/healthcare world?
Many of the leading Indian generics manufacturers are anyway sold to multnationals in the last few years…
Ravi,
Thanks for your comment. No, in fact, both the House and Senate bills still contain a mandate for pharma manufacturers to serialize their prescription drugs (4 years after enactment), including the FDA’s Standardized Numeric Identifier (SNI) (which includes the NDC plus a unique serial number), the lot/batch and expiration date. One exception would be for packages that are too small to accommodate a barcode (although I find it hard to believe the FDA would be willing to grant such an exception).
The difference between these bills and the California pedigree law is that the Senate bill would not require wholesalers or pharmacies to make use of the serial number portion of the SNI until 10 years after enactment, and the House bill would never require its use.
“Brand Protection” technology applied by the manufacturers for the U.S. market means nothing (adds no value) to downstream trading partners so any money spent on those technologies should not be spent in an attempt to gain “pricing power”. That money should only be spent if a manufacturer can gain some advantage without expecting wholesalers and pharmacies to pay any attention to it–perhaps on returns or when a policing agency is investigating a crime.
Dirk.