Proactive steps may help pharma, medtech mitigate PFAS risk

By Oliver Steck, principal, and Mayura Gill, senior manager, Deloitte & Touche LLP

More than 70 million people might be drinking water contaminated by per- and polyfluorinated substances (PFAS), according to the Environmental Protection Agency (EPA), which evaluated 30% of water supplies in the United States.¹ PFAS is a class of chemicals commonly used in cleaning products, food packaging, clothing, cookware, pharmaceuticals, and medical devices.²

PFAS are often described as “forever chemicals” due to their inability to degrade naturally in the environment. They have been linked to a variety of health problems, including liver and immune system damage and some cancers. These chemicals accumulate not only in the environment but also our bodies.³ They can have a disproportionate impact on vulnerable populations as well as on women and children, impacting fertility, fetal growth, and child development.⁴

Over the past year, there has been a flurry of global activity around PFAS, including litigation,⁵ a proposed blanket restriction in the European Union (EU),⁶ and state and federal actions in the U.S. Lawsuits have already forced some manufacturers to phase out PFAS and pay large fines.⁷ This, combined with growing scrutiny from regulators around the world, has prompted some pharmaceutical and medical device manufacturers to take a close look at their products, materials, supply chains, and suppliers.

We lead Deloitte’s chemicals of concern risk-management strategy. Deloitte helps clients identify and mitigate the risks these chemicals could pose to consumer safety and their product portfolios. This is an important topic for corporations, but also for consumers who rely on pharmaceuticals and medical devices for their health and well-being. Deloitte recently conducted a webinar where we outlined steps companies can take to identify forever chemicals and remediate them throughout their portfolios and supply chains (click here to access a recording of Chemicals of Concern: Evolving regulations and their impact to portfolios).

Keeping up with regulations

A proposed EPA rule would make it illegal for manufacturers to release the most common PFAS into the environment without disclosing the quantity in their regulatory reporting.⁸ Last year, the EU proposed a gradual phase-out of all PFAS following a joint proposal from Germany, the Netherlands, Denmark, Norway, and Sweden. This could take effect as early as next year.⁹

Europe has already banned the use of another forever chemical—titanium dioxide (TiO2)—from food products,¹⁰ and there is a proposed ban for pharmaceuticals.¹¹ However, TiO2 is still used in the U.S. for a wide range of products including candy, toothpaste, and in pills and capsules where it serves a variety of purposes including reducing blotchiness and giving pills their signature bright white appearance.¹² If federal or state regulators were to ban TiO2, manufacturers would likely need to quickly pivot and find suitable alternatives for that ingredient.

In a blog last summer, we highlighted nitrosamines, another chemical of concern, which can be found in everything from grilled foods to cosmetics and pharmaceuticals (see Impurity regs may affect life sciences pipelines). While nitrosamines are considered safe in small quantities, high levels or prolonged exposure could increase the risk of cancer. They have been found in medications used to treat a wide range of conditions (e.g., hypertension, heartburn, and type 2 diabetes), which led to the recall of at least 10 widely use drugs.¹³

While there is no one-size-fits-all approach to assessing and remediating the risk that forever chemicals can pose to product portfolios, we urge our clients to consider the framework and governance structure below, which can be applied to almost all scenarios:

• Assess the potential impact of current and future regulations: Pharmaceutical and medical device manufacturers should consider developing a proactive risk-sensing strategy to evaluate evolving regulations and the possible implications for their portfolios. This mechanism should outline what would trigger the creation of a formal risk-management program. Companies should also determine what will likely need to change if regulators ban certain substances. Can a product be reformulated without the banned ingredient or chemical? How might this impact their supply chain? It is also important to determine how patients and customers could be impacted if alternative ingredients are used.
  
• Evaluate product portfolios: Companies should evaluate the potential existence of chemicals of concern in their finished products as well as potential exposure from manufacturing processes, upstream suppliers, manufacturing equipment, and product packaging. It is also important to understand alternative compounds and their likely impact on availability, cost, efficacy, feasibility, and safety. Reformulation of a pharmaceutical product can be a lengthy, cost-intensive process. Companies could proactively identify supply channels or manufacturers that produce alternatives to at-risk compounds.
  
• Test and confirm: Laboratory testing can help manufacturers determine how much of a chemical exists in a product and allow them to assess potential exposure. In the case of nitrosamines, regulators have already defined daily intake thresholds. Last summer, the Food & Drug Administration issued final guidance on acceptable levels of the impurity, and released a framework that manufacturers can use to assess “nitrosamine drug substance-related impurities” in their products.¹⁴ Confirmatory testing is a way to determine if a product contains an impurity above the established thresholds.
  
• Establish a proactive risk-mitigation strategy: A risk-mitigation strategy can act as an insurance policy if certain compounds become restricted. This strategy can include the identification of alternative supplies and suppliers. Remediation of products and processes can be a time-intensive and costly endeavor that goes above and beyond standard business operations. Companies should consider developing protocols for responding to regulatory queries. They should also try to evaluate the potential impact on the consumer experience to help maintain trust and confidence if a formulation needs to be changed.
  

Conclusion

There seems to be a lot of interest in PFAS and other forever chemicals by trade groups and the mainstream media. This has led to heightened awareness, and scrutiny, among some consumers. In the absence of a regulation, companies should try to be proactive and transparent about their efforts to remove potential risks associated with their products and brand. Taking a leading role in developing products that are safe for consumers and the environment is important to maintaining consumer trust and helping to ensure continued positive brand reputation.

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Endnotes:

^{1_{The EPA is proposing that 'forever chemicals' be considered hazardous substances, NPR, February 2, 2024}}

^{2_{What are PFAS?, National Institute of Environmental Health Sciences}}

^{3_{PFAS exposure and risk of cancer, National Cancer Institute}}

^{4_{Higher rate of PFAS in water in communities of color, Harvard T.H. Chan School of Public Health, May 15, 2023}}

^{5_{Forever chemicals’ were everywhere in 2023. Expect more litigation in 2024, Reuters, December 28, 2023}}

^{6_{US food faces PFAS challenge as European rules, policies expand, Bloomberg Law, September 12, 2023}}

^{7_{Chemical companies’ PFAS payouts are huge, but the problem is even bigger, The Guardian, August 3, 2023}}

^{8_{Biden-Harris Administration announces new steps to protect communities from PFAS, EPA press release, February 1, 2024}}

^{9_{US food faces PFAS challenge as European rules, policies expand, Bloomberg Law, September 12, 2023}}

^{10_{The EU bans titanium dioxide as a food additive, European Commission press release, January 18, 2022}}

^{11_{Pharma groups fight proposed ban on titanium dioxide in Europe, Regulatory Affairs Professional Society (RAPS), November 27, 2023}}

^{12_{Health advocates urge US regulators to ban common food coloring additive, The Guardian, June 2, 2023}}

^{13_{Information about nitrosamine impurities in medications, U.S. Food & Drug Administration, August 4, 2023}}

^{14_{Recommended acceptable intake limits for nitrosamine drug substance-related impurities, U.S. Food & Drug Administration, August 2023}}

This publication contains general information only and Deloitte is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or other professional advice or services. This publication is not a substitute for such professional advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified professional advisor.

Deloitte shall not be responsible for any loss sustained by any person who relies on this publication.

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