Last week, Dr. Ilisa Bernstein, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, spoke last week at the Healthcare Distribution Alliance (HDA) Traceability Seminar (see “HDA Traceability Seminar: RxTrace Future Topic List Explodes“). Her presentation went beyond the simple, tight-lipped, high-level review of the Drug Supply Chain Security Act (DSCSA) that is typical of recent FDA presentations at conferences. It was a refreshing change.
Dr. Bernstein started out her presentation saying that they have a very big team spread throughout the agency working on DSCSA implementation. There were eight people from the FDA registered to attend the event, according to the HDA’s event app. That’s more than I remember from past events. And for the first time, the FDA recently issued her a true smartphone, finally replacing her Blackberry.
According to Dr. Bernstein, the DSCSA focuses on the finished drug product moving all the way to the dispenser. They are really interested in who is touching the product, where are the vulnerabilities in the supply chain, and what are the threats. The goal is to lock those down—to minimize, reduce, mitigate—any of those vulnerabilities and threats. According to Dr. Bernstein, that’s what DSCSA is intended to do. “And in doing so, we are all charged with developing an electronic interoperable system by 2023 to identify and trace products as they move through the supply chain.”
“We’ve been very busy, at FDA, in the last year, drafting guidances, publishing guidances, rules and other things, to help with implementation, so I’m going to share some of that with you…”
She listed the following publications the FDA has published in the last twelve months:
- Draft guidance with FAQ’s regarding DSCSA annual reporting for wholesale distributors and 3PLs (see “FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting“)
- Office of the Inspector General (OIG) report on what wholesale distributors were passing in their DSCSA Transaction Documents
- Final guidance on identification of DSCSA suspect product and notification (see “FDA Finalizes Guidance On Suspect Product“)
- Draft guidance on identifying trading partners under the DSCSA (see “Identifying Trading Partners Under the DSCSA“)
- Draft compliance policy that delays enforcement of the DSCSA serialization and verification requirements for one year (see “FDA Delays Enforcement of DSCSA November Deadline: What It Means”)
- DSCSA pilot program RFC (see “HDMA Responds To FDA Pilots RFC“)
- Notice of public health emergencies and DSCSA requirements
“WHERE DO WE NEED TO GO?”
The FDA wants to partner with stakeholders in developing and identifying what is needed for the 2023 system. They want to hear from the industry, “What do you need from FDA? What is the most practical and efficient route in order to get where we need to be in 2023?”
To answer these questions, FDA has established the series of three DSCSA public meetings. The first was held in August, the next one will be held on December 5th and 6th, and the last will be held on February 28, 2018. There will likely be even more meetings after that, as necessary, she said.
Let me pause here to say, if you are registered to attend the next FDA DSCSA public meeting on December 5th and 6th in Silver Spring, MD—or even if you missed that opportunity—you’ll want to stick around an extra two days to attend IQPC’s Pharmaceutical Traceability Forum in Washington DC. This important event immediately follows the FDA DSCSA public meeting, but in a more comfortable location. You will find industry experts on the agenda who will recap and explain what the FDA said in the public meeting that just concluded, and what it means to you and your business. There is no better opportunity to quickly develop a deep understanding of where the FDA and the industry are at this moment in time, and where they are going over the next year and the next six years, through 2023. Here’s the best part. As an RxTrace reader, you get an incredible discount. So incredible that I can’t say in this essay how big it is. Use Discount Code: RxTrace_PharmaTrace20. Don’t miss it!
FDA’s VISION FOR 2023
Dr. Bernstein then displayed a slide that contained FDA’s vision for the Enhanced Drug Distribution Security (EDDS) phase that will begin on November 27, 2023 (see “5 Myths About The DSCSA In 2023“). The contents of this slide was the same as the one shown during the first FDA DSCSA public meeting in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals“). Here they are, along with some of the comments made by Dr. Bernstein for each one:
- Provide increased public health benefits
“We really need to create a tighter, closed system in order to prevent the introduction of suspect and illegitimate product into the supply chain, facilitate the detection of illegitimate product, and enable the rapid response when these products are found, and also to facilitate recalls.”
- Ensure diligence and vigilance by all trading partners
“To be a sentinel system that enables the identification of breaches within the supply chain and has checks of the product and the transaction documentation, and you can’t just have the product move from trading partner to trading partner, the information is there for a reason, so we need to figure out how do use it, how and when should it be used.” [NOTE: An earlier version of this essay misquoted Dr. Bernstein. I thought she said the system needed to be a “central” system when she really said “sentinel” system. I regret the error and the alarm that may have caused. –Dirk.]
- Support FDA’s compliance and enforcement efforts
“We need rapid access and visibility in order to meet the obligation that we have to the public. We are accountable to the American public, so this is an important aspect of the system in 2023.”
- Be adaptable and flexible
“As technology changes, the system should be able to advance without significant disruption to the supply chain.”
- Be interoperable with the health care system and global marketplace
“Although DSCSA does not require anything having to do with compatibility with the healthcare system and the global marketplace, in the long-term future, because of where everything is going in the world and the global marketplace and the healthcare system, there are some opportunities in the future. We’re not going to focus on that for 2023, but it’s something to think about for the future.”
Dr. Bernstein provided a glimpse into what the FDA is currently working on with that big/nice sized DSCSA team. They’ve been “really, really busy” working on guidances and regulations. There are a number that are “on the horizon, or in the near future”. These include:
The FDA was apparently “very close” to publishing this guidance a while back, but when they received some important comments to their compliance policy, enforcement delay draft guidance, they decided to pull it back and take another look at some of it. They do expect to publish it “very soon” (I’m sure they are close, but be aware that “soon” and “very soon” are code-words the FDA sometimes uses to mean “sometime in the next year or so”, see “FDA Speaks At GS1 Connect”, “HDA Delivers Home Run To Record-Breaking Audience” and “Blockchain Reigns At GS1 Connect 2017”).
- Standardization of data and documentation practices for product tracing
This is apparently a “level-setting” for the documentation and data of the information that must be passed. “We expect that soon.”
- Product Identifier, Questions and Answers
These questions and answers stem from questions the FDA has received about the DSCSA product identifier, and particularly “how it relates to barcodes, for the barcode rule”. (See “The DSCSA Product Identifier On Drug Packages“.)
- Verification systems
This will include a description of what should go into a verification system and “verification in a serialized world” (see “DSCSA Red Light Green Light: Verification Responses” and “DSCSA Verification and Suspect Product“).
- Waivers, exceptions and exemptions
Even though this guidance has not yet been published, FDA has “…on our website a place for people to submit any inquiries or information for a waiver, exception or exemption.” All I can find is an email address for submitting questions “…related to product tracing information, waivers, exceptions and exemptions, and trading partner requirements”: email@example.com. That must be what she is referring to. (See “Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance“.)
- Wholesale distributor and 3PL licensing and standards proposed rule
“Yes, I am very aware you’re waiting for that, and, it’s on its way.”
- Final versions of draft guidances that have been published, and,
- Other guidances related to wholesale distributor and 3PL licensing, including application, the accreditation program that is part of the law, and others she could not be specific about.
Dr. Bernstein then discussed some track and trace activities the FDA is doing globally. FDA has been working with their global counterparts, providing guidance, tools and expertise, and receiving lessons-learned from those agencies who have already implemented regulations. These include:
- The Asia Pacific Economic Community (APEC)
- The World Health Organization (WHO)
- The International Coalition of Medical Regulatory Authorities (ICMRA)
- The regulatory bodies working on the Falsified Medicines Directive (FMD)
- And others
Dr. Bernstein reported that there have been some FDA enforcement actions where they made use of the DSCSA transaction information (TI) to understand what occurred, and there have even been some criminal charges for lack of transaction documentation (see “DSCSA: Transaction Information“).
“What we have found in most cases, when illegitimate product is found, the transaction documentation is just not there, or it takes a while to get it. And so the system we are creating for 2023 in order to get the information rapidly, will help significantly in achieving our public health goal, in order to identify that product and get it out of the marketplace and contain any situation.”
“In terms of where we are going, there is a lot of behind-the-scenes activity that you’re not seeing in addition to some of these guidances and regulations. We’re building FDA IT capabilities, platforms and other IT in order to feed the needs for DSCSA implementation for licensing programs. We are developing processes, and have in place a number of processes and programs for when the licensing and inspection program does go into place.”
MY PARAPHRASING OF DR. BERNSTEIN’S DISCLAIMER
Dr. Bernstein concluded with a disclaimer. She wanted to let us all know that sometimes FDA speakers are quoted (like I have done here), but they cannot be held to anything in those quotes because they are only being paraphrased, and, the speaker’s presentation itself is only that speaker’s personal opinion and a paraphrase of the FDA’s actual positions (I’m paraphrasing here), and some of the information in the slides was summarized.
She makes a good point. The quotes I have included above and below are to the best of my ability to transcribe. I am human, which means I am prone to error. Even where I use quotation marks, don’t take the FDA to court over anything you read here. It won’t stand up. This is only for background and general understanding of Dr. Bernstein’s presentation.
Dr. Bernstein then took some questions from the audience. Here are some of them. I have heavily paraphrased these.
Will the FDA start requiring the drug package serial number in other reporting, such as adverse events? Can’t say they will require it or won’t require it in the future, but it is useful information.
Will the FDA delay the wholesaler’s 2019 date now that the manufacturer’s serialization date has been pushed back? Can’t say.
Some waivers have been given to some companies but she could not discuss them.
If a manufacturer is capable of transmiting TI/TH/TS electronically, but the recipient is not capable of receiving it that way, is it OK to send it in paper form? She will look into that.
How should verification requests be communicated? Guidance on verification is being worked on. The law just says that you have to have the systems and processes in place to do that.
Considering the delay, is it just product manufacturered after November 26, 2018, or is it product received at a 3PL, or is it products received at the wholesaler that have to be serialized? Stay tuned on that. We are looking at the comments we received for the compliance policy, we are going to be addressing whatever comments we received and reviewing them and modifying the compliance policy to address any of the questions we got. So I can’t answer that right here.
You said you were close to publishing the grandfathering guidance until you received comments on the compliance policy proposed rule, are you still reviewing those comments? I can’t say where we are in the process.
Regarding licensure, will you publish guidance, or a proposed rule? It’s a proposed rule.
Is email transmission of TI/TH/TS considered electronic? Right.
During your presentation you mentioned for 2023 a ‘sentinel system’. Can you explain more what a ‘sentinel system’ is in you opinion? It’s a system that’s on…it’s there…to the extent it could be helpful in finding problem products and transactions. How can we use and benefit from the fact that we have a fully electronic system in order to identify these maybe suspect products or transactions along the way. Ideally, we heard, how can you make this system show you some red flags? It’s kind of thinking about it in that type of way.
After the session was over, I found Dr. Bernstein and asked her my own questions, one-on-one. I asked, the compliance policy was issued as a draft. Should the industry asume that it’s permanent and final, or will it ever be finalized, or is it just an assumption that everyone is just going to follow it? We are planning on finalizing it. Before November 27? We are planning on finalizing it, I can’t tell the date. The draft is our current thinking.
To me, Dr. Bernstein was more open during this appearance than previous public appearances of FDA DSCSA speakers, although still not as open as the medical device group within the agency. I hope this level of openness continues.
If you attend the next FDA DSCSA public meeting and/or the IQPC Pharmaceutical Traceability Forum, find me and let me know what you think about this new openness.