Serialization's Delay Game
By Rob Wright, Chief Editor, Life Science Leader
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By Rob Wright
For pharmaceutical manufacturers holding out hope that California’s ePedigree law will be postponed, Virginia Herold, executive officer of the California State Board of Pharmacy, has stated that the 2015-to-2017 deadlines are firm and that there will be no further extensions. The California State Board of Pharmacy initially stepped into this area of regulation out of perceived need, in the absence of federal standards and in response to acts of counterfeiting and other threats to security, beginning the process of developing an infrastructure back in 2003. And yet, the delay game continues.
The most recent attack seeking to derail the implementation of California’s ePedigree law (under review at this writing and anticipating a decision before the end of June 2012) was put forward by the Pharmaceutical Distribution Security Alliance, a consortium organized specifically to reach consensus on end-to-end track-and-trace rules, pedigree, and serialization. Their proposal, the Pharmaceutical Traceability Enhancement Code (RxTEC) Act, also referred to as the “Securing Pharmaceutical Distribution Integrity Act of 2012,” is one more piece of legislation attempting to be attached to the reauthorization of the Prescription Drug User Fee Act (PDUFA) — essential to FDA funding in the new fiscal year, which begins Oct. 1, 2012. Henry Waxman (D-CA), ranking member of the House Energy and Commerce Committee, stated, “The User Fee add-ons are a long line,” warning that as add-ons mount, complexity of negotiation deepens. So why the last minute move? Why the delay of course?
The proposal, which appears to be backed by PhRMA, was filed by the Washington-based law firm Faegre Baker Daniels. The hope is that by going to Congress with one plan, they can gain acceptance of a national standard, which would supersede the California law. The earliest date that the RxTEC Act could take effect is sometime in 2020. Since it is proposed to begin implementation five years later than the California ePedigree law, you might expect it to be more complex and more thorough. In an eight-page letter to Waxman, dated May 9, 2012, California State Board of Pharmacy President Stanley Weisser outlines the inadequacies of the RxTEC proposal. “While we agree in principle that a uniform national standard would be ideal, we would like to see that standard a much closer approximation of the California model than is reflected in the RxTEC proposal. We would encourage something closer to the Bilbray-Matheson model of H.R. 3026.”
When I first became aware of California’s position, I felt there was a need for a national standard. Further, I wondered why a state should be involved at all. Now that I have gained more information, I understand the benefits of California taking a leadership role. Had California done nothing, nothing would have been done. After having read Weisser’s letter, I would argue that no national standard would be better than a substandard national standard. In typical pharma fashion, instead of seeing the opportunity to be gained by implementing a “Gold Standard” serialization program, which would result in the collection of tremendous amounts of data and the possibility of a wide variety of business opportunities, industry fell back on its own gold standard — the delay game.