As Donald Trump prepares to assume the presidency and with new leadership taking control of the Senate, significant shifts will come to the oversight of key health agencies like the Food and Drug Administration (FDA). In response, outgoing congressional leaders are poised to rush major health policy changes during the "lame duck" session – the period between election results and the incoming Congress. This approach is both inappropriate and risky, with the potential to harm patients. Nowhere is this concern more relevant than with the misleadingly titled Biosimilar Red Tape Elimination Act.
If passed, the Biosimilar Red tape Elimination Act would jeopardize the health of millions of Americans, erode physician and patient confidence in certain medicines, and override patient protections established in all 50 states.
Much like the Inflation Reduction Act, whose name bore little resemblance to its actual content, the Biosimilar Red Tape Elimination Act is a misnomer designed to obscure its true impact. Biologic medications are complex treatments made from living organisms and used to treat patients diagnosed with complex or chronic conditions. Biologics are effective and transformed treatment to help people manage daily symptoms that come with chronic conditions. However, the treatments are often expensive, limiting access for patients who need them most. To increase access, an alternative was created, called biosimilars, which some considered to be a “generic” version of the biologic it is modeled after.
However, while safe and effective, biosimilars are not identical to their reference product and require different guidelines to be able to substitute the biosimilar for a biologic. Laws in all 50 states, which are supported by medical societies and patient advocacy groups nationwide, and current federal regulation requires that only biosimilars designated as “interchangeable” by the FDA can be substituted without physician involvement.
The FDA approves biosimilars to be interchangeable after reviewing additional data that demonstrates that patient outcomes will not be negatively impacted from a switch to a biosimilar. However, if passed, the Biosimilar Red Tape Elimination Act would classify all biosimilars as interchangeable without requiring additional analysis or data. Insurers and pharmacy benefit managers (PBMs) nationwide would be able to switch patients to their preferred – and often most profitable – products regardless of “interchangeable” designation. Inappropriate switching may affect treatment stability and safety for patients.
Proponents of the bill have continuously cited alarming factual errors that suggest even the sponsors do not understand the science or the implications of this policy. The sponsors have falsely claimed that biosimilars are “equivalent” to generics; yet the FDA says, “biosimilars are not generics and important differences exist between them.” Supporters of the bill claim that clinical switching studies are required to substitute interchangeable biosimilars at the pharmacy when, in fact, the FDA has broad discretion on what data is required. A majority of interchangeable biosimilars were approved without such studies. Additionally, supporters of this bill incorrectly claim that loosening the standards for interchangeability will align U.S. policy with Europe. Contrary to what supporters of the bill claim, this policy will not align U.S. biosimilar regulations with those in Europe. The European Medical Authority (EMA) refers to “interchangeability” as prescription substitutions by physicians and not third-party substitution of biosimilars at the pharmacy counter – a practice that is rare and frequently banned in European Countries.
U.S. physicians, who are experts in prescribing these treatments, overwhelmingly oppose the bill’s provisions. A recent survey found that 88% support individual evaluations for biosimilar interchangeability, and the same percentage see switching studies as essential to increasing confidence in these medicines. Only 11% of physicians support the FDA deeming all biosimilars as interchangeable without further data, as this bill would mandate.
President-Elect Trump’s nominee for FDA Commissioner, Dr. Marty Makary, would be tasked with taking on the consequences of decreasing the FDA’s rigorous data standards. Congress should not remove discretionary regulatory authority from the FDA without allowing Dr. Makary an opportunity to weigh in.
The 2024 election sent a clear message: voters want policies that reflect their interests. And every voter is also a patient. It is both inappropriate and irresponsible for outgoing congressional leaders to push through a significant and contentious shift in public health policy during a lame duck session and without thorough vetting through the legislative process. Congress should instead approach this issue with due consideration and deference to incoming Congressional and FDA leadership.
Michael Reilly served in the Office of the Secretary of the U.S. Department of Health and Human Services from 2002-2008, including three years as Associate Deputy Secretary. He is Executive Director of the Alliance for Safe Biologic Medicines.
