There’s nothing like a high profile tragedy to get Congress to act. Last year, you may recall, a fungal meningitis outbreak from steroid pain injections contaminated with mold killed 64 people and severely sickened more than 750 more across the country. The outbreak was traced to a massive compounding pharmacy operation, the now-shuttered New England Compounding Center (NECC) in Framingham, MA. Inspectors cited a plethora of unsterile manufacturing practices, but not before the company had shipped more than 17,600 doses of the tainted drug to 23 states and NECC’s owners and other company executives made off with millions. Then in late September, while the media (and most of the rest of us) were focused on the debate to raise the debt ceiling and the disastrous enrollment rollout of President Obama’s signature legislation, The Affordable Health Care Act, both the House and the Senate worked quickly and quietly, and without fanfare, to pass H.R. 3204 — The Drug Quality and Security Act.

The DQSA was introduced to the House floor on September 27, 2013 to amend the Food Drug & Cosmetic Act by providing voluntary oversight and closing the legal — but unethical — loopholes that until now, have allowed large-scale compounding pharmacies to operate under the radar and skirt both state and federal regulations. It passed in the House of Representatives by voice vote the day after it was introduced, was approved by the Senate three weeks later, and signed into law by the President just before he left for his Thanksgiving holiday.

Title II, the much lengthier “Security Act” portion of the Bill, was added almost as an afterthought.  Earlier in the year, the Senate combined portions of an approved House Bill (H.R.-1919) addressing supply chain security with new compounding pharmacy regulation. This came after years of lobbying and drafting resolutions surrounding track-and-trace requirements. Most never made it out of committee. The Senate told the House that the combined bill was much more likely to get through and it was just the rework the supply chain legislation needed to sail through Congress.

The provisions set forth in Title II of the Act establishes authority for the FDA to develop (during the next 10 years beginning January 1, 2015) a national track-and-trace system to secure the pharma supply chain and minimize opportunities for what the Bill defines as “illegitimate products”: those contaminated, adulterated, diverted, stolen, counterfeited and fraudulently transacted. On December 3, 2013 the FDA held its first public stakeholders conference call to discuss the new law and has embraced the notion of vigorous collaboration with industry to ensure successful adoption of these provisions through product tracing, identification, verification, detection, response and notification of suspect and illegitimate product, and ultimately for an interoperable electronic system for unit-level drug tracing. And while industry as a whole strongly supports this legislation, many are disappointed with the protracted timeline for implementation.

More specifically, provisions of the Drug Security Title include:

Drug manufacturers, wholesale distributors, re-packagers and, for the first time, third-party logistics providers having to undergo a federal registration and periodic review process, the cost for which has not yet been established;

All drugs for sale in the U.S. will contain a unique product identifier and tracked at the lot level beginning in January 2015, a challenging goal to say the least;

Incremental tractability at the pallet, case/package and unit levels is to occur during a 10-year period extending the length of the supply chain;

Records must be retained for six years, with By 2025 FDA will issue guidance on an electronic, interoperable system for tracking drugs at the unit level;

Dispensers (pharmacies) will capture drug identification label information, or have that data stored by their distributor/supplier; FDA will analyze the burdens and capabilities of dispensers with fewer than 25 employees, and come up with appropriate guidance.

For all of its focus on drug pedigree and security, the bill myopically overlooks any potential harm in the legitimate supply chain by making no reference to maintaining the quality of the drug product by verifying proper storage and handling at each transaction. Verification is limited by definition to “whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the re-packager.” And transaction is defined as “transfer of product between persons in which a change of ownership occurs.” There are innumerable exceptions to the latter.

The bill is a modest step forward, but a significant portion of “drug quality” is ensuring proper storage and handling throughout the process.  The only passage alluding to this is in Subchapter H, SEC. 581 (8)(D), defining an Illegitimate product as “a product for which credible evidence shows that the product appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.” Really? That’s all you got?

One could always defer to the Food Drug & Cosmetic Act’s definition of an adulterated drug for backup. But if Congress were informed and educated to the potential dangers of mishandled drug products, particularly temperature-sensitive drugs, and ensured that that was indeed an integral part of a secure supply chain, could they not have just thrown us a bone rather than wait for the next preventable tragedy? CP

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Kevin O’Donnell
Contributing Editor

Kevin O’Donnell is senior partner at Exelsius Cold Chain Management Consultancy – U.S. He is the former chair for the International Air Transport Association (IATA) Time & Temperature Task Force, a member of the USP Expert Committee on Packaging, Storage and Distribution, a temporary advisor and certified mentor to the World Health Organization (WHO), co-author of PDA Technical Report No. 39, and a member of the International Safe Transit Association (ISTA) Thermal Council. He blogs at www.clutchcargo.us. He can be reached at kevin.odonnell@exelsius.us.