Senators clear medicine-tracking bill for floor debate

Two bills designed to shore up the security of the US medicine supply chain have been combined and approved for debate on the Senate floor.

The two bills - S. 959 (the Pharmaceutical Compounding Quality and Accountability Act) and S. 957 (Drug Supply Chain Security Act) - were passed by the Senate Health Education Labor and Pensions (HELP) committee earlier this week. The video of the committee meeting is available here.

The bills were debated and approved with no further amendments and strong support from both Democrats and Republicans, which bodes well for fruitful debate in the Senate in the coming weeks and months.

S. 959 was prompted by the notorious case last year of a fungal meningitis outbreak caused by dubious production practices at compounding pharmacies in the US which claimed more than 50 lives, and will give the US Food and Drug Administration (FDA) the necessary powers - and responsibility - for oversight of the trade, according to HELP Committee chair Senator Tom Harkin (D-Iowa; pictured).

The Act establishes three categories for the businesses that make compounded drugs. The first category, traditional pharmacies, will continue to be regulated at the state level, while drug manufacturers will continue to be regulated by the FDA. The legislation creates a new category for large-scale drug compounders - compounding manufacturers  - that will also fall under the FDA's oversight.

If the legislation is passed on the Senate floor "there will be no confusion about who is in charge of keep products safe," Ranking Member Sen. Lamar Alexander (R-Tenn) told the committee meeting. 

"I do not intend to sit through another meeting where the FDA can point its finger at someone else instead of taking responsibility for its failure to regulate large-scale compounding or claim it did not have clear enough authority."

The FDA is reported to be working on the development of specific Good Manufacturing Practice (GMP) guidance for compounding manufacturers.

S. 957 introduces a track-and-trace requirement for prescription medicines, boosts accountability across the supply chain through measures such as requiring licensing of third-party logistics providers and lays out what must be done when counterfeit, stolen or diverted medicines are encountered.

Sen. Alexander said the Act would create over the next few years "a tracking system for those 4 billion prescriptions made by over 88 manufacturers on over 3,600 manufacturing lines, which are distributed to patients in a variety of ways, including by 60,000 pharmacies or drug stores".

As reported by SecuringIndustry.com last month, S.957 would create a lot-level traceability system that within 10 years of adoption would be upgraded to full unit-level traceability of medicines.

"We know more from the barcode on a bottle of milk than we do for a bottle of pills" said bill co-author Sen. Michael Bennet (D-Colo), adding that this is something that is not fully understood by the majority of the American public.

The committee voted that S. 957 would be incorporated within S.959 and go forward to the Senate floor for further debate.

With a traceability bill also heading for debate in the House of Representatives, (see House drug traceability bill makes stride forward), the foundations at least have been built for federal traceability legislation which would pre-empt state level initiatives, including California's electronic pedigree requirements which are due to come into effect in 2015.

Both houses still have to arrive on a common text before legislation can be enacted so there is a long road to travel just yet, particularly as the House bill has been criticised for setting too long a timeframe before unit-level track-and-trace could be required.