As discussed by the Star Tribune’s June 27 editorial (“Needed action on ‘forever chemicals'”), the Environmental Protection Agency is seeking to create clean drinking water thresholds on per- and polyfluoroalkyl substances (PFAS). Given the history of egregious cases of chemical dumping, like what was done by Dupont, popularized by the film “Dark Waters” with Mark Ruffalo, one can see why the EPA is taking such an approach to how PFAS are regulated in the United States.
Strangely enough though, the EPA’s approach to PFAS is at odds with another government body, the Food and Drug Administration.
The FDA, the regulatory body responsible for ensuring that pharmaceuticals and medical devices work and that their health benefits outweigh their known risks, has continuously approved both drugs and devices that contain PFAS. Most don’t know that the medical community is heavily reliant on PFAS products. Take, for example, medical implants like vascular grafts, stent grafts, surgical meshes, catheter tubes/wire and heart patches. It is estimated that 8% to 10% of Americans have implantable medical devices, many of which rely on PFAS and are approved by the FDA. In fact, the implantable medical-devices market, valued at $72.2 billion, is expected to grow significantly as the American population continues to get older.
Drugs containing PFAS and conditions with treatments that introduce the presence of PFAS include, but are not limited to, tachyarrhythmias (flecainide), antidepressants (fluoxetine), nonsteroidal anti-inflammatories (celecoxib), antibiotics (levofloxacin), rheumatoid arthritis therapeutics (leflunomide), cholesterol-lowering agents (atorvastin) and even COVID-19 antivirals such as Paxlovid.
For all of those drugs and devices, the notoriously overcautious FDA has clearly stated that whatever PFAS exposure exists with these products, they are safe to the point where the benefits far outweigh the risks. Simply put, the presence of PFAS for these drugs and devices passes a safety check and a cost-benefit analysis.
What we have here is two government agencies taking drastically different approaches to the issue of PFAS. On one hand, the FDA is doing a cost-benefit analysis and approving the use of PFAS across the medical sector, while the EPA is seeking to enact drinking water standards that are mutually exclusive to the FDA’s conclusions.
So how should regulators proceed given that the left hand and right hand of the federal government appear to be at odds with each other? One key step forward would be to individually assess each chemical within the PFAS umbrella, identify where hazards exist and calculate where Americans are actually at risk — with “risk” being the hazard present multiplied by the exposure levels.
After doing so, regulators should focus on ensuring proper production practices to avoid instances of dumping, and severely punish those companies caught being reckless in the production or disposal process. That is the approach that can keep Americans safe and their drinking water clean, without running the risk of having the regulatory system be so stringent that production ceases and American patients are left without the lifesaving drugs and devices they need.
Luckily, some voices of reason have emerged in Congress, like that of Rep. Larry Buschon of Indiana. As a heart surgeon by trade, he has rightfully pointed out that the heavy-handed approach would put lifesaving medical technologies at risk. Hopefully, more will listen, and the federal government, in coordination with state regulators, can both limit PFAS exposure where it is dangerous and allow for it to continue to be used where safe.
Originally published here