OPINION: Sen. Luján wrong to support cutting corners on medicine safety protocols

Trust and transparency are essential to improving public health and patient care for residents of New Mexico. Doctors rely on federal guidelines that are driven by science to inform treatments they prescribe to patients. Weakening these guidelines, particularly for medicines used to treat chronic or serious illnesses, is a dangerous gamble that unnecessarily risks patient safety.

Patients diagnosed with chronic or serious illnesses, including cancer, rheumatoid arthritis, Crohn’s disease, psoriasis, and more, often rely on complex medicines to manage daily symptoms. These medicines, called biologics, are lifesaving and have helped increase quality of life for chronic disease patients. However, biologics often come with high costs that make them inaccessible for some patients, highlighting the need for more affordable alternatives.

Fortunately, the introduction of an alternative to biologics, called biosimilars, opened the door for more people to access critical treatments at a lower cost. Although biosimilars are not identical to the biologic they are modeled after, they are safe and effective. The success in increasing access to biosimilars depends on public trust in these medicines which has been established because of strict U.S. Food & Drug Administration (FDA) standards for approving biosimilars, standards that could be undermined by Congress.

Under current laws in New Mexico, and all 50 states, a biosimilar must earn the designation of “interchangeable” from the FDA before it can be substituted for its reference product at the pharmacy counter without physician approval. Earning this designation requires clear evidence that patients can be safely switched between the two products without negative outcomes or impacts to treatment efficacy.

Previously, Congress considered a bill that would sweep these safeguards aside, labeling all biosimilars as interchangeable without requiring the necessary data to prove their safety — and similar bills could be proposed in 2025.

This policy leaves critical treatment decisions to insurance companies and pharmacy benefit managers (PBMs), enabling them to substitute medications without input from the prescribing doctor. Insurers and PBMs often switch medications for patients based solely on cost considerations, prioritizing the most profitable medications. This could prove disastrous for patients living with chronic illnesses who often spend years fine-tuning their treatments to achieve stability and efficacy and improve quality of life.

Physicians overwhelmingly oppose these types of policies, and for good reason. A recent survey of doctors who prescribe biosimilars found that only 11% of physicians believe all biosimilars should be deemed “interchangeable.” Nearly 90% of doctors value the rigorous FDA review process for determining interchangeability and believe that the required studies are particularly important in building their confidence in biosimilar substitution.

As a New Mexico physician and a former official at the U.S. Department of Health and Human Services (HHS), I was disheartened to learn that U.S. Sen. Ben Ray Luján, D-New Mexico, has supported efforts to loosen biosimilar standards. We must take steps to reduce health care costs, but cutting corners on safety protocols is not a solution. It’s a recipe for eroding quality, equity, and trust in our health care system.

Patients deserve better, and New Mexicans expect their leaders to stand up for policies that protect their health and safety rather than undermine them.

The current FDA standards for biosimilars have achieved a delicate balance of promoting innovation and equitable access to affordable treatments while maintaining high standards of safety and efficacy. This balance has given both patients and physicians the confidence to embrace these new medicines. Policies that override these standards threaten to unravel years of science-based progress.

I urge New Mexico lawmakers to reaffirm their commitment to putting patients first and oppose changes to biosimilar standards. Let’s keep health care decisions where they belong — in the trusted partnership between doctors, health care providers, and their patients.

Dr. Cristina V. Beato is an Albuquerque physician and former acting assistant secretary for health at the U.S. Department of Health and Human Services.