Welcome back, my friends, to the enforcement debate that never ends!
The California Board of Pharmacy (CA BoP) is meeting today to consider the January 1, 2009, implementation deadline for e-pedigree along with the new CA pedigree legislation. (Read the agenda.) Similar to my prediction prior to the last meeting in CA Pedigree: Going to '11?, I think the Board will pontificate about “the industry as a whole” and once again avoid a vote on delaying implementation until 2011.
However, I have a new theory for you about why the Board will not be able to implement e-pedigree even if they decline to adjust the deadline. I also have a few connect-the-dots ideas suggesting that the Board is not even planning to enforce anything.
If you attend the meeting, drop me a line and I’ll post a synthesis of perspectives. As always, your anonymity is guaranteed.
IS PEDIGREE AN UNDERGROUND REGULATION?
As you may know, pedigree is covered in sections 4034 and 4163 of the California Business and Professions Code.
According to California’s Office of Administrative Law, all state agencies are required to adopt regulations following the procedures established in the Administrative Procedure Act (APA). If a state agency issues, enforces, or attempts to enforce a rule without following the APA, the rule is called an “underground regulation.” State agencies are prohibited from enforcing underground regulations.
I’m no lawyer, but California’s pedigree laws still seem “susceptible to interpretation,” a key test for APA procedures. (See What is a Regulation?) The CA Board of Pharmacy is using a great of judgmental discretion in carrying out its duties, as I point out in Pedigree and Obscenity.
Bryan Liang went further last week in his editorial “Protection against counterfeit drugs too important to rush” when he wrote: “Those participating in the supply chain — from pharmaceutical companies to community clinics to mom-and-pop drugstores — are greatly concerned about implementing a law that won’t work because of the unanswered questions of what an e-pedigree would entail — including what standard is right for the entire chain, what technology to use, what frequencies are mandated, how pill containers versus injectables would be treated, how to weather the costs of pedigree readers and writers, and, critically, who would be the owner, guardian and steward of the information.”
Similarly, David Fong, Pharm.D., senior VP of pharmacy & family care at Safeway, echoed these comments in a recent Drug Topics article: “We don’t believe that on January 1, 2009, the supply chain will be ready to comply with the rule.”
So has the CA Board of Pharmacy followed APA? If there are reasonable grounds to suspect that the Board has not followed APA, then a simple legal challenge will prevent the Board from enforcing pedigree laws on January 1, 2009. (Fair warning: This is not legal advice. See disclaimer below. Your mileage may vary.)
GETTING READY FOR … NOTHING?
Through my work with Secure Symbology, I have seen first-hand that an integrated serialization/e-pedigree solution can be implemented on a high-speed packaging line using 2-D bar codes. However, many (most?) manufacturers, wholesalers, and pharmacies will not be ready by the arbitrary deadline of 1/1/09. While counterfeit drugs remain an ongoing threat, there seems to be little logical or fact-based rationale for rushing ahead with a law that is still susceptible to interpretation.
So, does the Board (privately) expect a delay?
Clue #1: The Board of Pharmacy’s budget will increase by only 2.5 percent and they will add no new positions in the fiscal year during which it implements e-pedigree. (See Pedigree and Obscenity.) Huh?
Clue #2: Judith Nurse, Supervising Inspector at the CA Board of Pharmacy, spoke by telephone at the SecurePharma conference in February. I wrote down the following quote: “We do not want to be the pedigree police.” Does this statement mean that the Board plans not to enforce the pedigree law?
Clue #3: I asked Ms. Nurse the following question at SecurePharma: “It seems likely that many manufacturers and wholesalers will not be able to comply with the pedigree laws by January 1, 2009. What contingency plans has the Board of Pharmacy prepared to handle such a situation?” Ms. Nurse replied: “We have not developed any contingency plans.” If this is supposed to make consumers feel safer, then I’m really worried!
DO AS I SAY…
According to its own assessment, the CA BoP’s staffing is “insufficient to perform mandated duties at desired levels.” Perhaps that explains why the CA Board of Pharmacy has not yet bothered to post the minutes from January’s Public Board Meeting on the Board and Committee Meetings section of its own website (as of March 24).
Guess they need more time to comply.