Alert | Congress Needs to Act Fast to Fores . . .
Congress Needs to Act Fast to Forestall California’s Track-and-Trace System: Lawmaker
With the final FDA user fee legislation lacking language to support a national track-and-trace system for pharmaceuticals, Congress must now act fast to preempt California's epedigree law, slated to go into effect in 2015, Sen. Michael Bennet (D-Colo.) says.
“Everybody would be better off with a national approach to this,” Bennet said.
“A state-by-state approach is not going to get us where we need to be from an economic point of view, and from a safety point of view, so we are going to keep working on it,” Bennet added at a conference on biomedical innovation in Washington, D.C., hosted by the Brookings Institution.
He vowed to search for an alternative legislative vehicle to advance a U.S. tracking system.
Pharmaceutical companies and pharmacies have largely opposed anything more than lot-level tracking, claiming it would be too burdensome and costly. But the FDA has persistently prodded Congress for authority to implement a national system using technology that tags individual product packages electronically. FDA Commissioner Margaret Hamburg, also in attendance at the Brookings event, declined to comment on the new user fee bill's lack of track-and-trace language.
During negotiations on the FDA Safety and Innovation Act, S. 3187 — the final, reconciled bill reauthorizing the Prescription Drug User Fee Act (PDUFA) — Sens. Bennet and Richard Burr (R-N.C.) offered a compromise proposal for authorizing enforcement of a U.S. tracking system.
But consensus could not be reached on a method for implementing a system at the unit level, so the requirement failed to make its way into the legislation, which is now headed to President Barack Obama's desk to be signed into law.
Speaking from the Senate floor June 26, Sen. Tom Harkin (D-Iowa), chair of the Senate Committee on Health, Education, Labor, & Pensions, urged pharma supply chain stakeholders to “build a coalition” around a unit-level tracking plan.
California's Looming Deadlines
Meanwhile, drugmakers face a growing patchwork of state drug tracking laws, the beefiest of which is California's impending “epedigree” drug-tracking system, set to take effect in phases starting in 2015. By January of that year, 50 percent of each company's total product entering the state's outsized market must be serialized. Drugmakers have until 2016 to serialize the other half.
Drugmakers are given leeway to decide which products to tag first, be it based on risk or market share, Virginia Herold, executive director of the California State Board of Pharmacy, said.
California law extends and staggers the compliance window for wholesalers (July 2016) and pharmacies (July 2017), Herold added.
Once the law takes effect in California, no wholesaler or pharmacy may sell, trade or transfer a prescription drug at wholesale without an epedigree. And for California sales, no wholesaler or pharmacy may acquire a prescription drug without receiving an epedigree. The law requires the manufacturer to initiate the pedigree and pass it through the distribution chain, with each owner appending the epedigree.
California's track-and-trace system is modeled after a unit-level plan first put forth by the FDA in 2004. The “electronic safety net” envisioned by the agency would require a manufacturer, re-packager, re-labeler, distributor, retailer and others acting at the agency's direction to attach radio-frequency identification (RFID) tags to immediate containers, secondary packaging, shipping containers and/or pallets of drugs being placed into commerce.
The FDA's proposal went further than the California law in that it called for tracking the possessor of the drug product and not just ownership, Herold noted. The California legislature has not mandated use of RFID chips; however, each pedigree must contain the following information:
- The source of the drug, including the drugmaker's name, federal registration number or state license number and mailing address;
- The trade or generic name of the drug, the quantity of the drug, it's dosage form and strength, the date of the transaction, the sales invoice number, the container size, the number of containers, the expiration dates and the lot numbers;
- Each subsequent owner's business name and shipping information, including the name and address of each person certifying delivery or receipt of the drug; and
- A certification under penalty of perjury from a responsible party of the source of the drug that the information contained in the pedigree is true and accurate.
The requirement of a pedigree tracking each drug down to the smallest scalable unit is the only way to effectively track and prevent counterfeits or drug adulteration, Herold said. Without an electronic record tracking each change of ownership, including lateral wholesaler-to-wholesaler transfers, there is no reliable audit trail available for sourcing pharmaceutical fakes, she added.
Any return of a “dangerous drug” to a wholesaler or manufacturer also must be noted on the pedigree, according to current California law.
The legislation is still undergoing changes and California officials are still ironing out how to streamline linkage of unique identifiers on product units to containers and palettes, Herold said.
But despite those efforts, officials say they would happily cede their program to the FDA. “We need a strong, solid track-and-trace system out there that is uniformly used by all supply chain members, and we need the FDA to be in charge of it,” Herold said. — June 2012