Why is there such a wide gap between the actions of the UDI face of the FDA and the DSCSA face?
The U.S. Food and Drug Administration (FDA) is an agency of the U.S. government that falls under the Department of Health and Human Services, which is under the leadership of the current Presidential Administration through a cabinet seat. But it is also a concept, and the concept has been conceived, modified, adjusted, influenced and expanded—especially expanded—by many thousands of members of Congress that have served from 1906 to 2016. It started as a nearly powerless monitoring agency in 1906 with the passage of the Federal Food and Drugs Act. But in the aftermath of a number of widely-reported incidents of harm and deaths caused by cosmetics and medicines, the Congress passed the original Food, Drug and Cosmetics Act (FD&C) in 1938 and President Franklin D. Roosevelt signed it into law.
Right from the beginning you had an agency with at least three faces: foods, drugs and cosmetics. I’m using the term “face” to refer to an agency subdivision with which certain companies must interact and which creates regulations that those companies must follow. I don’t know what has been going on behind the Food and the Cosmetics faces, but the Drugs face has been adjusted and expanded with seemingly every session of Congress since that time. To the original Drug face was added a Medical Devices face, a Biologics face, and, depending on how far you carry the idea of “faces” on an agency, a Generic Drug face, a Tobacco face and perhaps a Combination Product face. These faces were each created by one or more laws passed by Congress and signed by the President at the time. With the passage of the Drug Quality and Security Act (DQSA) in 2013, Congress created two more faces: Compounded Drugs and Pharma Supply Chain Security. Prior to the DQSA the FDA had little authority to regulate the drug supply chain. That was mainly handled by each of the 50 states through their local state board of pharmacy.
So we are still at the beginning of a new era. The FDA’s responsibilities include regulating, monitoring and enforcing the Drug Supply Chain Security Act (DSCSA), which was Title II of the DQSA. For simplicity, let’s call the Pharma Supply Chain Security face, the “DSCSA face”.
Not long before Congress created the DSCSA face in November of 2013, the FDA itself created what I will call their Unique Device Identification (UDI) face. That happened in September of 2013 in response to the passage of the FDA Amendments Act (FDAAA) of 2007 and the FDA Safety and Innovation Act (FDASIA) of 2012, which, among many other unrelated things, the former law contained a small section that instructed the FDA to “…promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier…[which]… shall adequately identify the device through distribution and use, and may include information on the lot or serial number.”
Contrast that simple statement, which led to the UDI regulation and the UDI face of the FDA, with the length and detail of the DSCSA that led to the DSCSA face. The main reason Congress was willing to even consider creating the DSCSA was to help the legitimate companies in the pharma supply chain stop the mind-numbing inefficiencies of operating a complex supply chain on a national scale in the face of 50 potentially differing supply chain security regulations. To do that I guess they needed to spell out a lot of stuff. Establishing the authority within the FDA for the creation of a standardized unique identifier scheme like UDI apparently doesn’t really take much detail, so we have this striking difference in detail from Congress.
Of course, with the minimalist UDI direction from Congress, the FDA had to bone up on technologies that they previously had no reason to understand. That is, the technologies behind identifying things uniquely (see “FDA Proposed UDI: A Revolution In Number Assignment” and “FDA Proposed UDI: AIDC Requirements”). Isn’t it interesting that Congress was willing to leave all that up to the FDA to figure out, but when it came to technologies needed to secure the pharma supply chain, Congress felt the need to nail down almost every last technical detail, even going so far to specify exactly which data-carrier technology must be used (a data matrix barcode)! I find this contrast amazing.
WHAT HAS THE DSCSA FACE DONE SO FAR?
Let’s take a look at what these two faces have accomplished since their creation. The DSCSA face has held one workshop in May of 2014 and another is scheduled for later this spring (see “FDA To Hold DSCSA Pilots Workshop“). It has produced three webinar recordings that explains their understanding of the DSCSA, identification of suspect product and annual reporting of wholesale distributors and 3PLs. It created 4 draft guidance documents in 2014, plus one guidance document which simply delayed enforcement of certain provisions scheduled by Congress. The only guidance document created in 2015 (and updated again in 2015) was to delay the enforcement of other provisions scheduled by Congress. It is overdue to publish four additional DSCSA guidance documents (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“). It has selected a private consulting group to help it define and execute one or more industry pilots in the coming year (see “FDA Looking For Consulting Org To Run DSCSA Pilots“).
But they have not answered many questions the industry has raised about exactly how they should prepare to meet the fast approaching deadlines. Of course, a big reason is probably the complexity of the law and the difficulty in drawing up an agency agreement on the intent of Congress on a number of technical and operational topics. The DSCSA is not nearly as clear in its meaning, or as consistent throughout, as the E.U. Falsified Medicines Directive (FMD) and Delegated Regulation (EUDR) (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning”), but I am not yet ready to say one is better than the other in securing the supply chain (more thoughts on that in a future essay).
WHAT HAS THE UDI FACE DONE SO FAR?
The UDI face of the FDA has published the UDI Final Rule in 2013 and six additional guidance documents since then. They have produced six webinars on various UDI topics. They have staffed a UDI Help Desk, which I have heard good reviews about. They and the industry have met two major deadlines (see “UDI Deadline For Class III Medical Devices Quickly Approaching”). And they have held six annual public UDI conferences (four were held before the regulation was even finalized) and one public UDI workshop. What is billed as the Eighth Annual UDI Conference, led by the FDA UDI Team, will be held in Baltimore, MD on April 18-19.
These events have earned my highest praise for providing the maximum value to companies who manufacture, sell, distribute, buy, stock and administer or dispense medical devices in the United States. These events are run by a third-party, but they are run on behalf of the FDA itself so the FDA UDI team can help companies understand what they need to do, and answer their questions. Take one look at the agenda and you will see what I mean. That’s why I have volunteered RxTrace as a media sponsor for the event every year since 2012. You can take advantage of this when you register. Use the Promo Code “RX” and receive $100 off the registration fee.
Why is it so much easier to get information from the UDI face of the FDA than the DSCSA face? I don’t know, but I am eternally hopeful that things are about to turn around. If the approaching FDA DSCSA Workshop is no better at answering questions than the one in 2014, then I am afraid we will be forced to continue waiting. On the other hand, if the DSCSA face has learned something from the UDI face about how to hold a workshop that offers value to the attendees, then maybe we are about to get what we have been hoping for. But remember, the purpose of this workshop is only to discuss proposed design objectives for one or more pilots to test technology aimed at 2023, so don’t hold your breath.