Regulatory Focus™ > News Articles > Track and Trace, Compounding Legislation Could See Senate Passage as Early as Today

Track and Trace, Compounding Legislation Could See Senate Passage as Early as Today

Posted 31 October 2013 | By Alexander Gaffney, RAC

The US Senate appears poised to take up legislation that would dramatically overhaul the regulation of both traditional and compounded pharmaceutical products as early as today, giving new life to a bill that has been set aside several times.


The legislation in question is known as the Drug Quality and Security Act (DQSA)and contains two main sections: one which would institute a nationwide pharmaceutical track and trace system, and another that would overhaul the regulation of pharmaceutical compounding practices.

The legislation was prompted by two issues. The first and perhaps most serious problem has been the lack of a uniform "track and trace" system for pharmaceutical products. While California has moved to implement just such a system, legislators have been interested in implementing a national standard to avoid other states introducing competing ones. The other hope, of course, is that the system will allow regulators to keep better track of the pharmaceutical supply chain, cutting down on counterfeiters and allowing them to respond more quickly to other problems as well.

The second problem, and the subject of numerous congressional hearings, has been the issue of drug compounding. Under federal law, pharmaceutical compounders are treated as separate entities from pharmaceutical manufacturers, and are allowed to operate under state-not federal-oversight. In late 2012, a massive outbreak of fungal meningitis caused by contaminated steroid injections caused legislators to re-evaluate that paradigm.

Lengthy Delays

While the legislation has received generally positive support from legislators, it has been placed on hold several times as several more pressing issues have emerged. In 2012, the track and trace provisions were dropped from the Food and Drug Administration Safety and Innovation Act (FDASIA) after differences emerged and legislators feared that the must-pass legislation could be hijacked for other purposes if it was not passed before the Supreme Court made a decision with respect to the legality of the Affordable Care Act.

The legislative effort then went on to include pharmaceutical compounding provisions as well, but both were put on hold early in 2013 as budget battles occupied the attention of legislators. In April, efforts by the pharmaceutical trade groups PhRMA and GPhA seemed to bring legislators back to the table, and the DQSA eventually saw passage in the House.

But since then, the DQSA has stalled out once again, and again thanks to budget battles that saw the federal government mostly shut down through the first half of October 2013. And as Focus reported on 24 October 2013, that led to another effort by the public health advocacy group Pew Charitable Trusts to get legislators to finally vote on the bill.

Vote Imminent

Now the legislation may finally be close to passage after all. On 30 October 2013, Senate Democrats announced that they are working on an agreement to consider the DQSA, formally known as H.R. 3204, "as early as today."

Typically, legislators do not bring a bill up for a vote unless it has a good chance of passage. The bill had earlier passed in the House of Representatives-currently controlled by Republicans-by voice vote, indicating a wide margin of support.

If passed as-is, the DQSA would then need to be signed by President Barack Obama before it would become law. If any changes are made to the legislation in the Senate, legislators would meet to iron out any differences between their legislation in a conference committee, and the final legislation would need to be agreed to by both chambers of Congress again before being signed by the president.

To date, the White House has not issued any statements either in support or opposition to the bill.

Senate Statement on DQSA

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