A compromise bill is in the works, say Washington sources
When the Senate and House were deliberating on pharma track-and-trace last spring and summer (and when there was talk of having a bill ready for President Obama’s signature around the Fourth of July), the belief was that the bill would be a priority action when Congress reconvened after Labor Day. It’s now nearing the end of the month and nothing has happened publicly. Recognizing this, two groups—the Pharmaceutical Distribution Security Alliance (PDSA) and Pew Charitable Trusts (which has an internal group called the Prescription Project) have sent a joint letter to the leaders of the relevant House and Senate committees, pushing for action. PDSA represents a wide swath of the entire US pharma supply chain, ranging from manufacturers to retail pharmacies.
As petitions to Congress go, the letter is fairly mild: “Leaders in Congress have been working on a bipartisan basis for two years to craft a national supply chain solution. … Now is the time for both chambers to act so a final bill can be signed into law as quickly as possible to provide the stronger level of protection our healthcare consumers deserve.”
According to Washington sources, House and Senate committee staffs have been working intensely on the two versions of the pharma supply-chain bill. The most significant difference between the two is that the House bill (which passed the entire House) does not include provisions covering compounding pharmacies, while the Senate version (which passed through a committee) does. Another key difference is that the House bill puts a “ceiling” on what states can require for pharma distribution security, while the Senate version does not—thereby potentially allowing California’s more restrictive track-and-trace system to go into effect. (California has a deadline of January 2015 to begin regulating drug distribution at the item level with pedigrees—but the California law also has a provision to allow it to be superseded by federal legislation.) Strictly speaking, the House bill never actually requires FDA to establish track-and-trace rules, but it’s hard to imagine all this effort winding up as merely a request for FDA to consider that.
Whether the bills actually come to the floors of Congress is anyone’s guess. Ironically, though, the harsh impasse over issues like the federal budget and the debt ceiling—issues that threaten to shut much of the federal government down—may actually work in the track-and-trace bills’ favor. Congress will want to show that they can do something productive, even while they are at a stalemate over the larger issues.