Lawmakers: Track-and-Trace System
No Sub for Thorough Drug Pedigrees
Published June 18, 2012 in Washington Drug Letter
http://www.fdanews.com/newsletter/article?articleId=147271&issueId=15876
Some Democratic lawmakers are pushing for a drug pedigree system to combat potential “gray marketing” of shortage drugs, arguing that a national track-and-trace system would not be enough to secure the supply chain.
A track-and-trace system requiring only lot-level tracing “would provide no information about who takes custody of these drugs after the lot is opened and individual units are distributed,” according to Sen. John Rockefeller (D-W.Va.) and Rep. Elijah Cummings (D-Md.).
A unique identifier may help determine if a drug is counterfeit but doesn’t prove it has been handled properly, the lawmakers wrote Monday to the Democratic and Republican heads of committees authorizing pending FDA user fee bills.
Rockefeller, chair of the Senate commerce committee, and Cummings, ranking member of the House oversight committee, urged additional steps for downstream parties to follow individual drug units they buy or sell if Congress were to include a national track-and-trace system in the final user fee bill.
While lawmakers inch closer to reauthorizing the Prescription Drug User Fee Act (PDUFA) and passing a bevy of other regulatory reforms, the future of a national track-and-trace system is in doubt. Industry stakeholders, the FDA and policymakers on Capitol Hill continue to wrestle with details of creating a massive system for inclusion in the PDUFA reauthorization bill (WDL, May 28). Congress aims to have a bill ready to sign into law before the Fourth of July holiday.
Pharmaceutical companies have largely opposed anything more than lot-level tracing, claiming it would be too burdensome and costly. The FDA supports unit-level tracing to provide real-time information on counterfeiters (WDL, March 12). Meanwhile, congressional leaders oppose preempting state programs, creating an impasse for the three sides.
Allan Coukell, director of medical programs at the Pew Health Group, told WDL a national track-and-trace system that could be included in PDUFA isn’t dead, but is not progressing. There still is no consensus among stakeholders, even after almost six weeks of meetings, and “as time goes by, it gets harder,” he said. Pew is one negotiator discussing specifics of a trace-and-trace law for possible inclusion in PDUFA legislation.
Action Rolls On
Even without a national track-and-trace system for drugs, Congress is making efforts to tighten the supply chain and limit gray marketing.
The FDA Safety and Innovation Act, S. 3187, currently being merged with the FDA Reform Act, H.R. 5651, would expand registration requirements for parties throughout the supply chain. It also would require product listing information to include excipient establishments.
Cummings filed last month the Gray Market Drug Reform and Transparency Act, H.R. 5853, which would require drug sellers provide price information to buyers to create transparency in markups.
Rockefeller and Cummings have been investigating gray marketing of critical drugs in short supply since last fall. The lawmakers say they plan to present further results of their investigation at an upcoming hearing, but none has been scheduled yet.
Until then, findings from the Rockefeller-Cummings report this week include:
http://www.fdanews.com/newsletter/article?articleId=147271&issueId=15876
Some Democratic lawmakers are pushing for a drug pedigree system to combat potential “gray marketing” of shortage drugs, arguing that a national track-and-trace system would not be enough to secure the supply chain.
A track-and-trace system requiring only lot-level tracing “would provide no information about who takes custody of these drugs after the lot is opened and individual units are distributed,” according to Sen. John Rockefeller (D-W.Va.) and Rep. Elijah Cummings (D-Md.).
A unique identifier may help determine if a drug is counterfeit but doesn’t prove it has been handled properly, the lawmakers wrote Monday to the Democratic and Republican heads of committees authorizing pending FDA user fee bills.
Rockefeller, chair of the Senate commerce committee, and Cummings, ranking member of the House oversight committee, urged additional steps for downstream parties to follow individual drug units they buy or sell if Congress were to include a national track-and-trace system in the final user fee bill.
While lawmakers inch closer to reauthorizing the Prescription Drug User Fee Act (PDUFA) and passing a bevy of other regulatory reforms, the future of a national track-and-trace system is in doubt. Industry stakeholders, the FDA and policymakers on Capitol Hill continue to wrestle with details of creating a massive system for inclusion in the PDUFA reauthorization bill (WDL, May 28). Congress aims to have a bill ready to sign into law before the Fourth of July holiday.
Pharmaceutical companies have largely opposed anything more than lot-level tracing, claiming it would be too burdensome and costly. The FDA supports unit-level tracing to provide real-time information on counterfeiters (WDL, March 12). Meanwhile, congressional leaders oppose preempting state programs, creating an impasse for the three sides.
Allan Coukell, director of medical programs at the Pew Health Group, told WDL a national track-and-trace system that could be included in PDUFA isn’t dead, but is not progressing. There still is no consensus among stakeholders, even after almost six weeks of meetings, and “as time goes by, it gets harder,” he said. Pew is one negotiator discussing specifics of a trace-and-trace law for possible inclusion in PDUFA legislation.
Action Rolls On
Even without a national track-and-trace system for drugs, Congress is making efforts to tighten the supply chain and limit gray marketing.
The FDA Safety and Innovation Act, S. 3187, currently being merged with the FDA Reform Act, H.R. 5651, would expand registration requirements for parties throughout the supply chain. It also would require product listing information to include excipient establishments.
Cummings filed last month the Gray Market Drug Reform and Transparency Act, H.R. 5853, which would require drug sellers provide price information to buyers to create transparency in markups.
Rockefeller and Cummings have been investigating gray marketing of critical drugs in short supply since last fall. The lawmakers say they plan to present further results of their investigation at an upcoming hearing, but none has been scheduled yet.
Until then, findings from the Rockefeller-Cummings report this week include:
- Drugs in short supply often do not reach healthcare providers through typical processes;
- Drugs that pass through the gray market are marked up at each stage, often to hundreds of times higher than the prices hospitals normally pay;
- Gray market transactions involve small volumes of drugs, often five or 10 units per deal;
- Wholesalers sometimes buy drugs in short supply only to resell them to other wholesalers rather than providers; and
- Drugs in the gray market often are not handled according to their labels.