PDMA drug pedigree reemerges...or does it?

I was thinking about PDMA this week. What PDMA you ask? I am referring to the Prescription Drug Marketing Act of 1987 (enacted by Congress in 1988) that contained several clauses intended help protect American consumers and the overall drug supply from the risk of counterfeit, diverted or adulterated pharmaceuticals. To this end, PDMA established that a “pedigree” or chain of custody of the drug would be created that provided legitimate participants in the drug distribution system with a history of a drug's source.



Why was I thinking about PDMA? Because in a little noticed action back in September, the Federal District Court in Eastern New York threw out a suit (RxUSA Wholesale Inc. v. Alcon Laboratories Inc. et al.) which had the effect of creating an injunction against the FDA from implementing the law. [Kudos to Pharmaceutical Commerce for its coverage of this event.] Thus ends another saga in the somewhat tumultuous history of the PDMA and its supporting rules.

For those that weren’t keeping score, here are the highlights. After enactment, the PDMA was modified by the Prescription Drug Amendments Act of 1992. The PDMA required the FDA to promulgate implementing regulations with respect to the pedigree provisions. As a result, the agency issued a proposed rule in 1994 and published a set of final regulations to the Federal Register (64 FR 67720) in 1999. Due to a variety of concerns raised at the time, the FDA delayed the effective date of two sections of the law. In 2006, the FDA finally announced that it would no longer delay the effective date and everything looked set for December 1, 2006. Until…that is…a complaint was filed in federal district court by a set of wholesale distributors which sought judgment against 21 CFR 203.50 for a variety of reasons including potentially anti-competitive behavior. The complaint was quickly followed up with a movement for preliminary injunction seeking to stay the effective date once again until there was a final resolution of the case. The FDA appealed in the spring of 2007, the injunction stopping enforcement against non-Authorized Distributors of Record was upheld in July 2007 and the issue bounced around in the courts for the next two years. With this September 2009 ruling in New York, that time seems to have come.

What I am curious about is what next shoe will drop. The regulatory environment is very different now in 2009 than it was back in 2006. Back then, Florida had just implemented a pretty stringent set of pedigree regulations that had caused an initial upsurge in industry adoption of pedigreed drug products. California was coming right on the heels of Florida in 2007 and numerous other states were either enacting or discussing pedigree regulations. So, even though PDMA had its own unique set of data and process rules, it was just one more requirement to put into the hopper while companies were very active with projects in this area.

Today, life is different. The state environment is much less active, particularly given the California delay to 2015+. Many companies have already implemented their systems and processes to handle current business and operational requirements in this area. Much of the current work going on focuses on drug serialization, secure distribution and overall pharmaceutical traceability pilots. Instead, all eyes are turned towards the federal government but for very different reasons than PDMA. The FDA’s Amendments Act of 2007 (FDAAA) kicked off a set of initiatives and FDA guidance, one facet of which relates to the development of standardized numerical identifiers (SNIs) for prescription drug packages. As originally stated, by March 2010, the FDA shall develop a standard identifier and by October 2012 all manufacturers and repackagers of pharmaceutical drugs in the US have to have applied package level SNI’s to their product lines. In addition, bills such as Buyer-Matheson and others continue to get introduced in Congress which have varying levels of pedigree, pharmaceutical traceability, drug serialization and other track and trace requirements. And yes…there is something about heath care reform I seem to remember hearing something about.

While there are a myriad of details related to the FDAAA, SNIs and the general concept of a serialized “federal pedigree” which are beyond the scope of this particular post, it does throw into question the current role of the PDMA pedigree and the FDA’s support of it. Now that the road is clear, will the FDA push forward with more vigorous enforcement beyond than which was laid out in the Compliance Policy Guide back in 2006? Will the FDA keep its powder dry given the onset of new regulations stemming from FDAAA and other federal initiatives? Will the ongoing health care reform debate and its implications for FDA policy keep this issue generally on the back burner for now? Finally, does the concept of “pedigree” as defined in PDMA even make sense in this environment? With all the ongoing analysis, debate and technology work occurring in serialization technology, EPCIS systems and other track and trace approaches, is the best approach to just start fresh with pharmaceutical traceability?

My view is that it might be hard for the FDA to justify any aggressive enforcement of PDMA at this point given the potential for new pharmaceutical traceability requirements next year and the uncertain implications for the industry given health care reform.

I see that at the upcoming HDMA Track and Trace Technology event starting on Nov. 30th, David Dorsey, Deputy Commissioner for Policy, Planning and Budget for the FDA will be speaking. Mr. Dorsey’s presentation will cover broad ground including the aforementioned FDAAA regulations and the SNI initiative. It will be interesting to see if Mr. Dorsey will also provide a glimpse in to the current thinking on PDMA. Our own Peter Monahan will be providing a detailed readout of the entire HDMA event. So, check back to see if PDMA has emerged from the shadows and what other hot button issues have bubbled up!

Comments

Anonymous commented on 24-Jan-2010 06:15 PM

If I am not mistaken, the September ruling on the RxUSA suit is a separate case from the RxUSA, et. al., vs. FDA pedigree lawsuit. The suit that was ruled on in Sept. was RxUSA's suit against various distributors and manufacturers for alleged restraint of trade violations -- i.e., not the suit challenging FDA's interpretation of the PDMA. The FDA pedigree case has yet to be heard and therefore could not have received a ruling -- the proposed pedigree rule is still very much enjoined. The plaintiffs and the FDA, in anticipation of the passage of the Buyer-Matheson pedigree bill being passed this year, agreed last year to approach the federal court hearing the case and request an postponement of the proceedings. Since both parties were in support of the Buyer-Matheson pedigree language, both thought it would be unnecessary to litigate an issue that would ultimately be rendered irrelevant by the legislation's enactment. Since, like everything else on Cap. Hill, pedigree has taken a back seat to health care reform efforts, it is anticipated that proceedings may be postponed in to 2010 to allow Congress an opportunity to move a pedigree bill.

Brian Daleiden commented on 24-Jan-2010 06:17 PM

You are indeed correct on the separation of the cases. Thank you for pointing that out. I should have been a bit clearer in my commentary on the court proceedings. The case against the plaintiffs mentioned (RxUSA v. Alcon et al) was ruled upon in Sept. This is indeed separate from the RxUSA v. HHS case directly affecting the FDA which is still in litigation. My read of RxUSA v. HHS was that the FDA was partially, but not completely, enjoined from implementing the pedigree provisions of PDMA given RxUSA v. HHS. The original preliminary injunction stopped the FDA from implementing two specific elements of the PDMA under 203.50(a): • Requiring that a pedigree identify each prior sale, purchase, or trade of a drug back to the drug’s original manufacturer. • Requiring that a broad set of information be encoded on a pedigree, including lot numbers and container sizes. Given that, the FDA put out a compliance policy guide clarifying some issues and stating that they (the FDA) decided to exercise enforcement discretion rather than potentially create confusion and enforce partial provisions of the PDMA. Thus, the FDA did not intend to initiate any enforcement actions against wholesalers solely for failure to either include extended data (lot numbers, dosage, etc.) or to provide a pedigree that goes back to the manufacturer as long as the pedigree otherwise identifies the last Authorized Distributor of Record that handed the pharmaceuticals. So, this is why I mentioned that in my view the ball is in the FDA’s court. My belief is that they could decide to change their view of enforcement discretion as stated in the policy guide on the issue. I will check on this opinion. But, I don’t see why they would given the other activities going on. I wholeheartedly agree with your closing thoughts. I believe the FDA would prefer a clear signal from Congress on a national "pedigree", however that is interpreted in the end.

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