Last Monday the Health Subcommittee of the House of Representatives Energy and Commerce Committee, chaired by Joe Pitts (R-PA16), published their own discussion draft of a national pharmaceutical track & trace bill and then on Thursday they held a hearing to discuss elements of it with a select group of witnesses. The draft was sponsored by Representatives Robert Latta (R-OH5) and Jim Matheson (D-UT4). The previous Friday the Senate Health, Education, Labor and Pensions Committee published a different discussion draft on the same topic, but held no hearing (see “The New Pharma Track & Trace Discussion Draft In The Senate”). In my essay about the Senate version I noted that if the House of Representatives were to publish a draft that was identical or close to the Senate version, that might be the signal that it had a good chance of being enacted.
Well, banish that thought. The two drafts are not the same and in some ways, they are not even close. I reviewed the Senate draft, then the House draft and then I watched the recording of the Energy & Commerce Committee hearing called “Securing Our Nation’s Prescription Drug Supply Chain”. I am not used to watching full meetings a the federal level so I was struck by how well the various Representatives seemed to understand the problems being targeted, the operation of the supply chain, the goals of track & trace and ePedigree, the differences of opinions on how to proceed and in some cases, the technologies being proposed.
I’m used to sitting in on State level committee meetings where it’s pretty clear that only the staff has that understanding. Clearly, this group of people has learned a lot since beginning work on a similar bill that they hoped to attach to what eventually became the FDA Safety and Innovation Act (FDASIA) last year. That effort failed (see “PDUFA Will Not Include RxTEC”), but they apparently continued work on it behind the scenes up to this time. The result is that the actual decision makers seem to have a grasp of the actual issues involved. I can’t tell you how refreshing that is to me. I recommend that you watch the replay.
THE ONLY PROBLEM IS…
The work last summer was billed as a “bi-partisan, bicameral” effort. That is, the subject and the debate was devoid of partisan politics, and both Houses of Congress were involved. After all, the goal of this type of legislation is to protect patients from harm. Who could oppose that? No one, it turns out. Of course not. Everyone stands up for patient safety without hesitation and without qualification. So why didn’t it pass last summer?
The devil is in the details. Everyone seems to agree that the United States finished pharmaceutical supply chain is the safest in the world. Everyone seems to agree that, despite being the safest, the supply chain is under frequent attack by some very sophisticated criminals. But no one knows how extensive that problem is (see “Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack”). Not only that, but there is no agreement on just how serious the threat is here compared to elsewhere and on the internet where the threat is well documented to be quite large. These variations in belief lead to widely differing opinions on how to shield ourselves against these criminal attacks.
As long as you cannot attribute any particular stance on protecting the supply chain to any particular political party, these opinions can vary widely and still be considered bi-partisan. That was apparently true until the House published their discussion draft last week. According to Representative Frank Pallone Jr. (D-NJ6), that new discussion draft was published by the House Republicans without consultation or involvement of the Democrats on the committee. Not only that, but he said during the hearing that the contents of the draft were, in some ways, “not even close” to the bi-partisan negotiated bill that they failed to pass last summer during the PDUFA debate.
That final negotiated bill last summer was not make public so I don’t know exactly which elements Mr. Pallone was referring to, but just the fact that he said it makes me think that perhaps this House version, anyway, is already in trouble.
The new House version has some big differences from the Senate version. In fact, the House draft is basically a lot-based pedigree bill. That is, once it becomes fully effective, supply chain participants would simply have to keep track of where they shipped drugs based on the lot number on the package. This is similar to the Florida pedigree law except that only wholesalers and repackagers are currently impacted by the requirements of that law. The Senate draft is also a lot-based pedigree bill but “only” for 10 years. After that it becomes a unit-level ePedigree law for some transactions.
In the Senate version the FDA would have to assess the feasibility of a unit-level requirement on dispensers that employ 25 or fewer employees. In that instance, they may be forced to offer alternate approaches or waivers. It’s a good thing for patients that it is “organized criminals” who are attacking the supply chain, as we are told. Hopefully these criminal organizations will find it too difficult to trim their workforces to just 25 staff gangsters by 2023 so at least at that time they will be forced to incriminate themselves on unit-level pedigrees, and the public will remain protected. Of course, if the House version passes, there isn’t any limit to the size that criminal organizations can be and still avoid unit-level incrimination. 😉
The House version is more relaxed in its timelines than the Senate version. In almost all instances of similar requirements the House draft would take more years for the requirement to take effect than the Senate version. Even the response time to a verification request of suspicious product is more relaxed in the House version—2 business days verses 24 hours in the Senate version.
Of course, both versions include the immediate preemption of all State pedigree laws. I believe enactment of either version would also result in the elimination of the pedigree provisions of the Federal Prescription Drug Marketing Act (PDMA), so the protection level of the U.S. drug supply chain would drop immediately. This was a big complaint of a number of the witnesses during the hearing. The FDA Office of Criminal Investigation (OCI) has used pedigrees to extract very efficient guilty pleas from a growing list of supply chain criminals in recent years (see “Pharma Supply Chain Criminals Get Justice” and “Pharma Supply Chain Criminals Get Justice, Part 2”).
During the hearing, Representative and full Committee chair Fred Upton (D-MI6) stated his hopes that the House version would enter the House markup phase in May and would be targeted for signature by the President before the August Congressional recess.
I hope to have more thoughts on both the House and Senate drafts in the coming weeks. In the meantime, let me know what you think of them.
UNEXPECTED SADNESS DURING THE HEARING
On a sad note, during the hearing I heard unexpected news from witness Mike Rose of J&J that our friend Steve Drucker passed away last week. Steve was most recently Global Commercialization Director for Merck’s Packaging Technology and Regulatory Compliance groups. I worked on at least one industry committee with Steve and most recently we ran into each other at a conference somewhere in the last year or so. I remember Steve as being very up-beat and cheerful all the time and he always had intriguing ideas. Steve was well known in the industry and he will be missed. See his obituary here.