Just as they did just prior to the U.S. House of Representatives vote on H.R. 1919 “Safeguarding America’s Pharmaceuticals Act of 2013” (see “InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities“), the Congressional Budget Office (CBO) just published their estimates of the public and private costs to implement S. 959 “Pharmaceutical Quality, Security, and Accountability Act” relative to the Federal Unfunded Mandates Reform Act (UMRA), paving the way for a vote in the Senate.
- “InBrief: A Track & Trace bill Has Made It To The Senate Floor“;
- “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives“;
- “The Federal Lot-Based Pedigree Before Congress“;
- “Would A U.S. Federal Pedigree Law Require A New UFA?” and
- “The Politics Of Federal Track & Trace Legislation“.
In this latest analysis the CBO has determined that the costs to State, local, and tribal governments if S. 959 were to be implemented would be “…small and below the intergovernmental threshold established by UMRA…”. However, they also estimate that the costs to private entities “…would exceed the threshold established in UMRA ($150 million in 2013, adjusted annually for inflation) in at least one of the first five years in which the mandates would be in effect”. Bottom line, this is close to what they said about H.R. 1919.
But keep in mind that there are major differences between S. 959 and H.R. 1919. The Senate pharma track & trace bill, S. 957 was merged with S. 959, the compounding pharmacy bill, and the resulting bill was re-christened S. 959. H.R. 1919 does not include any of the compounding pharmacy content found in S. 959. The CBO analysis took this into account, analyzing the effects of these two major sections separately before coming up with about the same overall assessment.
At least this time the CBO did not reference the old controversial Accenture/NACDS cost estimate study from 2008/2011 that they used improperly in their analysis of H.R. 1919. (See the 2008 version of “Current Status of Safety of the U.S. Prescription Drug Distribution System” here.)
The earlier CBO assessment didn’t seem to have any measurable impact on the passage of H.R. 1919 in the House and the new assessment isn’t likely to have any impact on the ultimate passage of S. 959. But at least the stage is now set for a vote on the Senate floor. If they could just get past the partisan bickering that seems to be swamping everything again this summer.