Friday, November 22, 2013
DQSA Senate Floor Comments: Clarifying Repackaging; Introducing a Patient Assistance Issue
As part of the ritual of completing a piece of legislation, members of Congress identified some of their pet issues for the future associated with the Drug Quality and Security Act. Senator Burr (R-NC) added a surprise one – the impact that the DQSA track and trace provisions might have on patient assistance programs.
There weren’t many surprises among the floor statements made surrounding the Senate’s vote on the compounding and track and trace bill, H.R. 3204, the Drug Quality and Security Act. Many Senators weighed in to make clear that, the intent of the compounding section of the act wasn’t to change the law on repackaging and office use of compounded drugs.
The Senate comments on that part of compounding provisions reprised similar assurances on the House floor and during a related House committee hearing on FDA issues. The extent of the new compounding provisions was a well-rehearsed and well-coordinated topic for repeated clarification.
There were also statements to identify the next efforts at controlling drug compounding – in the animal product area. Compounded animal drugs were actually part of a preliminary Senate draft leading up to the final DQSA. The approach of taking them out of the current legislation to make sure that it would continue to move and addressing them later had been publicly discussed during the legislative process.
All of these, office use, repackaging, and animal drugs, are areas where Senators have said they’ll be watching FDA action going forward.
One new concern emerged in the final floor comments: patient assistance programs and the track and trace provisions.
Senator Richard Burr (R-NC) noted the importance of PAPs as “a valuable and unique approach” to providing patients access to medications.
“As this legislation is implemented, the varied and unique approaches of PAPs should be taken into consideration to ensure patients who access needed treatments through these effective programs are able to continue accessing the prescription drug medications provided through PAPs,” he said.
This appears to be a last-minute issue with a long horizon. DQSA establishes electronic track and trace requirements to the unit level in ten years.
The issue appears to relate to whether companies – especially ex-US based --running PAPs might eventually have to create their own mini electronic track and trace systems for those programs.
Manufacturers with PAPs send products directly to a physician; the bill does not require physicians to receive information electronically. But, some companies were apparently worried that the bill could be interpreted to require PAPs to create electronic systems as well. There is a charity carve out in the law. However, that exclusion would not cover PAPs from foreign headquartered firms.
This is not clearly an immediate concern, but Burr’s comments helped give the issue some visibility and identify it as a subject for the process of bringing on electronic track and trace over the next decade. FDA must hold a number of workshops to hammer out the track and trace details and Burr’s concern is likely to be one of those details
quoted from here
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