The House of Representatives passed a bipartisan health care bill on Saturday (!) on a voice vote. H.R. 3204 was introduced by House Energy & Commerce Chair Fred Upton (R-MI 06) and co-sponsored by leading Democrats Dingell and Waxman. A companion bill awaits in the Senate. This bill might be on the President’s desk in no time and he will sign it. Who said Congress can’t get things done?
Of course your next question is – what have they done? We get three Acts of Congress for the price of one.
The Drug Quality and Security Act includes two subsidiary acts, the Compounding Quality Act and the Drug Supply Chain Security Act. The CQA creating an intermediate license safe harbor for large-scale drug compounding (called “outsourcing” in the bill). This is a tardy response to the NECC compounding tragedy from slightly more than a year ago. (TIE background here).
The DSCSA requires paper or electronic pedigrees on US drugs, strengthening the drug supply chain against diverted, stolen and counterfeited drugs. This is by far the largest part of the bill, with very little recent media scrutiny on this bill text. Congress has tried to pass a pedigree bill for many years. The US is the world’s largest market for high-priced drugs, which certainly attracts the attention of counterfeiters. You may be shocked to know that the government does not surveil our drug distribution network to check for counterfeit product.
No CRS summary is available yet (at least not on Thomas).
@koutterson
