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With today's greater combination of technology and know-how, we must design new ways to handle sensitive pharmaceuticals—and do it together 

Building the Cold Chain of the Future

pharma DSCSA compliance

 Following FDA’s implementation of the stabilization period last year, what is the pharma supply chain's overall preparedness in adhering to DSCSA’s Nov. 27, 2024 compliance deadline?

We're in a good place. It's not ready 100%, but FDA is implementing this one-year stabilization period, which allowed the supply chain to mature, and the connections really helped. We're at a much better place than we were last year, and we're closer to really being where we need to be, but there are still connections between trading partners where the data quality is poor, where there's discrepancies in information that's provided, and those need to be cleaned up. If there's a discrepancy or you don't have data, but you have product, that product can't move to the next trading partner, so a wholesaler can't sell it to a dispenser, and that means that product may not get to the patient who is waiting for it in the pharmacy.

All of these little end bits of data quality and making sure that your systems and processes are working and interoperable—that all has to be fixed and cleaned up. If you don't have that, if you're not ready, or your trading partner isn't ready, you got to go back and get that exemption, or WEE, that I talked about earlier.

 Although not required per the DSCSA, what have you heard in terms of companies tagging their products with RFID labels?

 Ten years ago—or even 15 years ago, we thought RFID was the next wave of making sure that you know where the product is, but we're not there. In fact, the DSCSA requires that two-dimensional barcode, and that takes enough real estate on the label and the package, that's where all of the focus is. Some companies are using RFID to help identify where a product is within their four walls, but it's not being used—as far as I know—for that tracking and tracing of a product through the supply chain. It's all focused on the two-dimensional barcode.

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, comments on industry’s preparedness for DSCSA compliance and provides an update as to where pharma is in terms of RFID label adoption. 

HDA 2024 Traceability Seminar: How Prepared Is Pharma for DSCSA Compliance?

KeySource, a wholesale supplier of generic prescription medications, has unveiled that Ryan Sevek—the company’s CFO—will become its president.1 A graduate of the University of Cincinnati Carl H. Lindner College of Business, Sevek has expressed interest in how the generic pharma industry contributes to United States’ healthcare landscape, and is a contributor to various industry groups.

His new responsibilities will entail heading the organization’s purchasing and sales divisions, while continuing to lead the company’s IT, logistics, and finance divisions.

“I am extremely pleased that Ryan is taking on the key role of president of our company. Since joining KeySource, he has been an outstanding leader, within and outside our company," said Albert Paonessa, CEO. “He has helped drive new systems and distribution capacity essential to the company’s success in recent years.”

Sevek was originally hired in 2017 as the director of finance, a position in which he was able to boost the KeySource’s financial processes and efficiencies; he was promoted to CFO five years later.

“I look forward to the continued challenge to drive value through the pharmaceutical supply chain, build lasting relationships within the industry, and continue to foster a culture at KeySource that puts patient care and our customers first,” noted Sevek. “I want to express my sincere thanks to leader, Albert Paonessa, and the board of directors for the privilege of serving as our company’s president. I accept these new responsibilities, confident in the ability of our entire KeySource team to further drive growth for our company, while enhancing the position of trust given to KeySource and industry partners by pharmacy providers, health care professionals, patients and the public at large.”

1. KeySource Promotes Ryan Sevek to President from CFO. KeySource. August 20, 2024. Accessed August 22, 2024. Press release provided via email.

Ryan Sevek, the supplier’s CFO, will become president. 

KeySource Unveils Internal Promotion

FDA Inspections

PC: You recently hosted a session on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance.” What points did you dive into during your presentation?

We talked about a lot of in general, what the FDA is inspecting. My key for this was trying to go for people that had never seen the FDA before, such as some of these warehouses and 3PLs. They may not have seen an FDA inspector before. So, what is an FDA audit? What types of audits and inspections can happen? Some of the documentation you'll see behind it, some of the forms they might use, you can be prepared to know what to expect from them and be given by them, as well as some of the things you can do to prepare and get yourself ready for the inevitable inspection. So, things such as having a process and a procedure in place, and, more importantly, training and practicing that procedure. Processes are a dime a dozen. If you don't train on them, they're worthless.

PC: What exactly is the FDA looking for during these inspections?

So, at its core, the FDA is looking to protect public health, and when they come in for an inspection, they're looking to see, do you have processes and procedures in place to the applicable regulations that they've implemented, and then what's the evidence you have that you are compliant and using those procedures applicably to those regulations? That's the simplest answer you can get for what they're looking for.

PC: What other session/topics at the Traceability Seminar have caught your eye thus far, and which upcoming ones are you looking forward to?

I sat in earlier on the topic for sale-able returns and how those are going to be handled. I think that's going to be a big challenge once this is fully implemented. I think having those things in place and figured out by that time is going to be a real challenge.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance" breakout session at the 2024 HDA Traceability Seminar.

Latest Conference Coverage

HDA 2024 Traceability Seminar: What to Expect From FDA Inspections

The first day of HDA’s Traceability Seminar was certainly not lacking educational sessions. Another fascinating one that I attended revolved around “Filing WEEs: Lessons Learned HDA Perspectives on DSCSA Implementation and Readiness,” featuring Elizabeth A. Gallenagh, general counsel and SVP, supply chain integrity, HDA; Tish E. Pahl, principal, Olsson Frank Weeda Terman Matz PC; and Brian P. Waldman, partner, ArentFox Schiff LLP.

, a WEE, or Waiver, Exception, or Exemption (WEE) request, is evaluated by FDA on a case-by-case basis.

The panel started off the discussion by reminding the audience of the small dispenser exemption that the FDA recently made, which essentially exempts dispensers with 25 or few full-time licensed pharmacists and qualified pharmacy technicians from package-level 2023 requirements until Nov. 27, 2026.

It’s important to note that although the deadline for trading partners to submit requests was Aug. 1, 2024, requests can be made at any time, but the FDA is unable to guarantee that it was act or make a ruling prior to the Nov. 27, 2024 date.

The panel outlined that a WEE should explain:

What specific DSCSA requirements you need relief from

What you’ve done so far/progress that’s been made

Why this specific request won’t create an issue for downstream trading partners.

Waldman also noted that as WEE should be a narrow as possible, meaning that if one needs an additional six months to comply, one should request six months, as opposed to more time, but nothing is guaranteed—as Pahl advised, “be prepared for what happens if you don’t get what you want.”

On July 29, the National Association of Chain Drug Stores (NACDS) submitted a letter—which Gallenagh noted is fully supported by HDA, who themselves have recommended a phased approach three times—to the FDA in which they asked for a phased approach when it came to implementation. In NACDS’ opinion,manufacturers should need to comply by the existing Nov. 27, 2024, while wholesale distributors should achieve full compliance 6-8 months later. As for dispensers—larger ones who have not been previously exempt by FDA—should have until Feb. 27, 2026 to comply.

Some might be wondering what NACDS’ justification is on these suggestions. The association believes that pharmacies shouldn’t be penalized for suppliers’ lack of compliance. They are also concerned for lack of compliance to result in supply disruptions, including drug shortages.

As the panel also stated, it even raises additional WEE concerns that could hold implications down the road, such as additional clarity being needed where a downstream trading partner seeks exemption for supplier non-compliance; the suggestion that WEE should be at national drug code level or NDC, not lot level; that granted WEEs should be applicable to 

 trading partners; and FDA should post all NDCs that are subject to exemptions and waivers in order to keep the entire supply chain informed.

This raises a key question for the FDA: being that the agency has vowed to prioritize patient access to medications, how does it proceed? Does it choose to break the DSCSA law in order to stay true to that oath?

Gallenagh EA, Pahl TE, Waldman BP.Filing WEEs: Lessons Learned HDA Perspectives on DSCSA Implementation and Readiness. August 27, 2024. HDA 2024 Traceability Seminar. Washington, DC.

Session uncovers distributors’ experiences with the Waiver, Exception, or Exemption request process, and how these affect the overall supply chain. 

HDA 2024 Traceability Seminar: DSCSA Implementation and Readiness

Touchlight, a contract development and manufacturing organization (CDMO) that specializes in enzymatic DNA production, will be providing its branded dbDNA (doggybone DNA) to the University of Nottingham for research and development of a DNA vaccine that combats the Zika virus.

 The material used in the clinical study abides by good manufacturing practices (GMPs).

The plan is for University of Nottingham scientists to lead the charge in designing the vaccine, which is expected to have the capability to be produced within weeks. Specifically, the process will involve a synthetic manufacture of the vaccine as opposed to bacterial fermentation, which slices the development time from six months to six weeks.

This project will be spearheaded by Dr. James Dixon from the university’s School of Pharmacy, alongside Professor Janet Daly, director of the University of Nottingham’s Wolfson Center for Global Virus Research. The DNA vaccine will be administered via injection.

According to Touchlight, enzymatic dbDNA technology allows for a quick, scalable, and efficient way to develop vaccines by offering the capability to decrease dosage, while eliminating antibiotic resistance. DNA vaccines also don’t require the same type of cold chain storage that mRNA vaccines would demand.

“The Touchlight technology has enabled us to make rapid progress and will make it possible to produce large quantities of the DNA vaccine at [a] speed which is vital in pandemic prevention and our response to deployment of vaccines in the developing world and globally,” said Dr. James Dixon.

Touchlight executives are also excited for the endeavor.

“We are thrilled to support the University of Nottingham with our innovative dbDNA technology in the development of a Zika virus DNA vaccine,” noted Tommy Duncan, Touchlight’s COO. “We are committed to enabling developers of DNA vaccines by providing rapid, high purity DNA for vaccines against emerging pathogens.”

On the other hand, regarding mRNA, Touchlight recently signed a license agreement with GSK, which centers around using the CDMO’s enzymatic dbDNA technology for mRNA-based products.

“GSK is a global leader in vaccination, and we are delighted they have licensed our proprietary enzymatic dbDNA technology for the development and production of their mRNA-based products,” commented Jonny Ohlson, executive chair and founder of Touchlight. “The adoption of Touchlight’s enzymatic DNA is gathering pace and becoming an important part of the advanced therapy supply chain. Our technology delivers the speed, scalability and high-quality DNA products that are essential for the next generation of mRNA therapeutics.”

1. Touchlight to supply GMP dbDNA to support University of Nottingham’s clinical study for a next-generation vaccine for Zika virus. 

t. August 21, 2024. Accessed August 21, 2024. 

https://www.touchlight.com/news/touchlight-to-supply-gmp-dbdna-to-support-university-of-nottinghams-clinical-study-for-a-next-generation-vaccine-for-zika-virus/#:~:text=Touchlight%2C%20an%20innovation%2Ddriven%20contract,vaccine%20targeting%20the%20Zika%20virus

2. Touchlight and GSK sign license agreement for use of enzymatic dbDNA production technology for mRNA manufacturing. 

t. July 23, 2024. Accessed August 21, 2024. 

Although it still has to undergo the preclinical and clinical trial process, the DNA vaccine—which could be created in as little as six weeks—does not require the cold chain storage that mRNA jabs often demand.

Touchlight, University of Nottingham Collaborate on Development of Zika Vaccine

The Inflation Reduction Act provides Medicare with the right to directly negotiate with drug companies as a way to improve access to various brand name Part B and D drugs. Never before has the federal government been able to bargain with drugmakers over the costs of the drugs they produce.

Keeping that in mind, on Thursday, Medicare officials released results of the first round of prescription drug negotiations for individuals with Medicare Part D, which would go into effect by 2026.

 People enrolled in the program are also expected to save $1.5 billion in out-of-pocket costs once those new prices are enacted.

The first 10 drugs that will see lower prices go into effect include:

Eliquis (by BMS and Pfizer), a blood thinner for the prevention and treatment of blood clots, which will receive a 56% discount off of the 2023 list price

Jardiance (by Boehringer Ingelheim and Eli Lilly) diabetes, heart failure, and chronic kidney diseases, which will receive a 66% discount off of the 2023 list price

Xarelto (by Johnson & Johnson) a blood thinner for the prevention and treatment of blood clots, and reduction of risk for patients with coronary or peripheral artery disease, which will receive a 62% discount off of the 2023 list price

Januvia (by Merck) for the treatment of diabetes, which will receive a 79% discount off of the 2023 list price

Farxiga (by Merck) for the treatment of diabetes, heart failure, and chronic kidney disease, which will receive a 68% discount off of the 2023 list price

Entresto (by Novartis) for heart failure, which will receive a 53% discount off of the 2023 list price

Enbrel (by Amgen) for the treatment of rheumatoid arthritis, psoriasis, amd psoriatic arthritis, which will receive a 67% discount off of the 2023 list price

Imbruvica (by AbbVie and Johnson & Johnson) for the treatment of blood cancers, which will receive a 38% discount off of the 2023 list price

Stelara (by Johnson & Johnson) for the treatment of psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, which will receive a 66% discount off of the 2023 list price

Fiasp, NovoLog (by Novo Nordisk) for the treatment of diabetes, which will receive a 76% discount off of the 2023 list price

The selected drugs were among those with the highest total spending when it came to Medicare Part D. Had these negotiated prices gone into effect in 2023 as opposed to 2026, Medicare would have saved an estimated $6 billion.

As noted above, this only represents the first round of negotiations. As part of Medicare’s drug price negotiation program, additional drugs will be chosen annually. Come next year, Medicare will be selecting as many 15 other drugs to be covered under Part D for negotiation, up to an additional 15 Part B and D drugs in 2026, and as many as 20 drugs every year following.

1. FACT SHEET: Biden-⁠Harris Administration Announces New, Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation to Lower Costs for Millions of Americans. 

. August 15, 2024. Accessed August 16, 2024. 

https://www.whitehouse.gov/briefing-room/statements-releases/2024/08/15/fact-sheet-biden-harris-administration-announces-new-lower-prices-for-first-ten-drugs-selected-for-medicare-price-negotiation-to-lower-costs-for-millions-of-americans/

2. Negotiating for Lower Drug Prices Works, Saves Billions. US Department of Health and Human Services. August 15, 2024. Accessed August 16, 2024. 

https://www.hhs.gov/about/news/2024/08/15/historic-first-biden-harris-administration-successfully-negotiates-medicare-drug-prices-delivers-promise-lower-prescription-drug-costs-american-seniors.html

By 2026, the first 10 drugs for individuals with Part D coverage—whose medications are mainly used to treat cancer, diabetes, and heart disease—will see discounts off of list prices ranging from 38-79%.

Joel Wayment and Jason Cook, Cardinal Health

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