PFAS and pharma: the implications of new regulations
Forever chemicals are under the regulatory microscope, and pharma companies will need to prepare for the impact of new requirements and restrictions.
Per- and poly-fluoroalkyl substances (PFAS) are a class of chemicals widely found in everyday life, including in grease-resistant paper, non-stick cookware and stain-resistant carpets. They are also found in a wide range of pharmaceutical products and medical devices. They are, in fact, extremely useful, hence their widespread use. However, many of them are also highly toxic.
Two years ago, these chemicals were being called ‘emerging contaminants’, as we started to understand both their toxicity and their environmental impact. Today, they are more likely to be described as “forever chemicals”’ because we now realize that they are extremely persistent in the environment. Their fluorination makes them very durable and slow to break down, even by the standards of plastics and other contaminants. Concerns about their environmental and health impact have led to governments and international bodies taking steps to phase out their use.
Introducing restrictions on PFAS use and manufacturing
Many governments either have or are in the process of introducing more stringent restrictions on producing and using PFAS chemicals in manufacturing and consumer products. This will also have an impact on the pharmaceutical industry. The changes to laws and regulations on the use and manufacturing of PFAS continue to evolve and we can expect more to come, some examples include:
- EU and UK REACH are laws on the registration, evaluation, authorization and restriction of chemicals, introduced in the EU in 2019 and in the UK in 2021. These place restrictions on the manufacturing, use, and marketing of PFAS.
- The US Toxic Substance Control Act (TSCA) requires more reporting and notification requirements for manufacturers, importers, and processors of PFAS to the Environmental Protection Agency.”
- There are new laws on drinking water protection being introduced in the US, EU countries, Australia, and elsewhere to reduce the contamination and residual level of PFAS in drinking water.
- In the US, the state of New Jersey has published soil remediation standards for four types of PFAS.
However, implementing these new regulations—and particularly phasing out PFAS use altogether—will not be straightforward. Many questions remain, from the definition to the impact of the changes.
The first issue is how to define PFAS. The most inclusive definition is proposed by the Organization for Economic Cooperation and Development (OECD). It defines PFAS as any chemicals that contain at least one fluorinated carbon atom. This broad definition covers around 12,000 chemicals in total, including several widely used pharmaceuticals, such as fluoexetine (Prozac) and avorstatin (Lipitor).
The US Environmental Protection Agency, however, has developed a much narrower ‘working definition’ of PFAS. Under this definition, chemicals must have at least two adjacent carbon atoms that are fluorinated, and at least one of those must be fully fluorinated. This definition covers around 6,500 of the 12,000 or so known chemicals covered by the broader definition.
The narrower definition seems to be about focusing on the most toxic or persistent chemicals. It recognizes that there is a balance to be struck between the costs and the benefits of these chemicals. However, it has been widely criticized because many of the chemicals that are not covered can be metabolized and/or decay into more toxic or enduring substances that are covered. Scientists have also cited the importance of the ‘precautionary principle’ when dealing with substances like this.
The issue of definition therefore makes it hard to know which substances will be covered by new regulations.
Essential uses of PFAS
There is no question about banning the use of PFAS in situations where there are obvious substitutes. For example, these chemicals will be banned in products such as firefighting foams. There is also no question about restricting manufacturing, use and marketing when products may contaminate food or drinking water. Food packaging and utensils, and bottles for water are all obvious examples of this.
There is less consensus on the regulation of PFAS and fluoropolymers in drugs and medical devices. It is clear from press coverage that there is concern about the Environment Protection Agency’s definition, and particularly that it does not match the scientific consensus. Some commentators go a lot further in both their tone and their demands for PFAS to be both removed from drugs and covered by legislation.
A recent article in the popular public health academic press suggests that the picture is nuanced. The authors suggest that there may be a case for excluding some or all pharmaceutical uses from regulations. However, this will need to be carefully considered, not least because of the implications for other health-related uses such as medical devices.
Fluoropolymers are used in many medical devices because of their chemical inertness and durability—just the characteristics that also make them undesirable. Examples of devices that use PFAS include implantable vascular grafts, heart patches, catheter tubes, and sterile containers. Research has already started on substitute materials, but the evidence so far is that the substitutes available at the moment are not likely to be as effective as PFAS. What is not in doubt is that the proposed ban on PFAS in the EU and in China would certainly affect specific medical devices.
Difficult questions raised by PFAS and pharma
Restrictions on the manufacturing, use and marketing of PFAS clearly have serious implications for healthcare-related industries, especially the pharmaceutical and medical devices sectors. There are few if any easy answers to the questions raised. Exemptions may be available in the short term but are unlikely to be seen as a long-term answer. And businesses must keep close watch as implementation and enforcement continue to develop. These industries need to prepare for stronger and more stringent restrictions—and in the meantime, look towards finding good substitutes.