A reprieve from California e-pedigree?

If packaging serialization legislation does pass Congress, manufacturers will have to pick up the pace, though they won't have to do so frantically, which they would if the California edict is left standing. The House bill, passed on the floor on June 3, is called the Safeguarding America's Pharmaceuticals Act of 2013 (H.R.1919). The Senate bill is the Drug Supply Chain Security Act (S. 957). Their objective is to prevent counterfeit drugs from insinuating themselves into the legitimate distribution network. The bills are fairly similar. Past Congresses have never gotten bills out of committee. So it looks almost certain that legislation will reach the White House for President Obama's signature, and probably sooner rather than later. A Coalition called the Pharmaceutical Distribution Security Alliance (PSDA), which includes the Pharmaceutical Research and Manufacturers of America, the generic industry's trade group and others, has pressed Congress to adopt a national program that would kick in later than California's.

However the regulations play out (if the President signs a compromise bill) with regard to prescription drug product identifiers, those regulations are likely to do very little to safeguard the nation's drug supply, despite the monikers of the bills. That is because neither bill requires either wholesalers or pharmacies to electronically "read" and "verify" the unique serial numbers identifying an individual package. Instead, wholesalers and pharmacies will have to verify "transaction history" and "transaction statements" prepared by the manufacturer and passed down the distribution line. These do not have to be in electronic form. They can be paper. Moreover, the transaction statements do not have to include the unique product identifiers for each of the packages in the "lot." The Senate bill requires the lot number to be included in the transaction statement; the House bill does not for five years after the bill passes.

Both bills, however, contemplate the U.S. Food and Drug Administration, sometime in the 2020s, starting a rulemaking, which would consider (the House) or mandate (the Senate) imposition nationally of a California e-pedigree unit-based package tracking system. However, the Senate bill contains all sorts of "if, ands, and buts," which would allow the FDA to "provide appropriate flexibility" by not requiring specific business systems for maintenance and transmission of data, providing alternative methods of compliance, "taking into consideration " the public health benefits of any additional regulations in comparison to the cost of compliance with such requirements, and a whole host of other factors that could turn any mandate into a piece of swiss cheese.

"The bill stipulates the FDA will hold regular meetings and conduct pilot programs with stakeholders to better inform the agency as to the feasibility of unit-level traceability and the processes needed to achieve that goal," Rep. Jim Matheson (D-Utah), prime sponsor of the House bill said on the House floor on June 3. "This is critical to ensure that the unit-level traceability regulation is achievable, does not increase prescription drug costs for consumers, and ultimately protects patients from counterfeit and adulterated prescription drug products."

Dirk Rodgers, an independent consultant and founder of RxTrace.com, and Healthcare Packaging contributing editor, says, "The bills remove the need to document which specific unit is in each shipment." So as anti-counterfeiting measures, both bills are ineffective. At least the Senate bill, by immediately mandating inclusion of the lot number in both the transaction statement and bar code, could more quickly improve product recalls.” But in that sense, the Senate bill only allows the manufacturer, facing a Heparin-type situation, to recall the haystack, not the needle. California's e-Pedigree program allows pinpointing of a defective needle.

Even though both bills pre-empt California, drug manufacturers have been restrained in their support. When the House passed its bill, the Pharmaceutical Distribution Security Alliance said, “We commend the House for passing this bill and look forward to working with the House and Senate to ensure that a strong and effective bill is sent soon to the President for his signature.” That implies the drug industry will be looking for changes in the language of the bills in any final, compromised version.