By Peter J. Pitts
June 16, 2026

Read the full article at RealClearHealth

One of the first things I learned during my time at the FDA was that biology rarely cooperates with political talking points. That’s not a criticism. It’s simply reality.

Biological medicines are complicated. Patients are complicated. Scientific evidence is often complicated. Anyone looking for simple answers is usually asking the wrong question. Which is why I find the current effort to “genericize” biosimilars so troubling.

Supporters of the Biosimilar Red Tape Elimination Act and similar proposals insist they are merely eliminating unnecessary red tape. Their argument sounds straightforward: if a biosimilar has been approved by FDA, why shouldn’t it automatically be deemed interchangeable and available for pharmacy-level substitution? It’s an appealing sound bite. It is also a remarkably poor way to make healthcare policy.

What strikes me most about this debate is how casually some people now dismiss distinctions that regulators around the world spent decades establishing. The FDA says biosimilars are not generics. The European Medicines Agency says biosimilars are not generics. Health Canada says biosimilars are not generics.

The World Health Organization says the generic-drug model is not appropriate for biosimilars. Australia agrees. Japan agrees. Brazil agrees. Yet somehow Washington has convinced itself that the real problem is that everyone else has been overthinking it.

That’s a bold position. It’s also an odd one.

When virtually every major regulatory authority in the world reaches the same scientific conclusion, the burden of proof should fall on those seeking to overturn it—not on those defending it. What makes this particularly frustrating is that many of the arguments driving the current debate are built on a false premise.

We’re told that FDA imposes rigid, burdensome requirements for interchangeable biosimilars. We’re told that switching studies are essentially mandatory. We’re told that scientific caution is preventing competition. None of these claims accurately describes the current system.

In reality, FDA already exercises considerable flexibility. The agency evaluates products individually. In some cases, it has required additional data. In others, it has not. Numerous interchangeable biosimilars have already been approved without switching studies. That isn’t bureaucracy. That’s scientific judgment. And there is a difference.

During my years at FDA, I never sat through a meeting where scientists argued that Congress should simply legislate the answer to a scientific question. The entire purpose of regulatory review was to determine whether the available evidence supported a conclusion. Sometimes the answer was yes. Sometimes it was no. Sometimes it was “we need more data.”

What nobody suggested was eliminating the question altogether. Yet that is increasingly where this debate seems headed. If FDA already possesses the authority to waive studies when science supports doing so—and it does—then why is Congress being asked to remove FDA’s discretion entirely? That’s the question supporters of these proposals rarely answer. Perhaps because the answer has very little to do with science.

The real barriers to biosimilar uptake are not sitting inside FDA headquarters in White Oak, Maryland. They are sitting inside formulary committees. They are embedded in rebate agreements. They are reflected in contracting arrangements that determine which products patients can access and which products never gain meaningful market share.

Congress knows this.

Congressional committees have spent years investigating the role of pharmacy benefit managers and the market distortions they create. Yet instead of addressing those issues directly, lawmakers are being encouraged to weaken a scientific determination that wasn’t causing the problem in the first place. That’s a curious policy choice. Actually, it’s worse than that. It risks solving the wrong problem while creating a new one.

The success of biosimilars in the United States did not happen because physicians abandoned scientific standards. It happened because they gained confidence in them.

Trust matters. Physicians trust biosimilars because they trust the review process behind them. Patients trust biosimilars because they trust their physicians. Undermine confidence in the process and you inevitably undermine confidence in the products. That’s not speculation. It’s human nature.

Another argument frequently advanced by advocates of “genericization” is that Europe has already moved in this direction. Having heard this claim repeated for years, I have become increasingly convinced that many people invoking Europe have not actually looked very carefully at what Europe does. European physicians routinely prescribe biosimilars. So do American physicians. But pharmacy-level substitution remains limited, uncommon, or restricted in many European countries. Europe did not create a generic-style automatic substitution framework for biologics. Yet that experience is repeatedly cited as justification for creating one here.

At some point, we should stop calling that harmonization and start calling it what it is: selective storytelling. None of this means biosimilar regulation should never evolve.

Science evolves. Analytical tools improve. Regulatory frameworks should adapt when evidence warrants adaptation. But there is a profound difference between refining scientific standards and pretending scientific distinctions no longer exist. The former is how regulatory science advances. The latter is how political narratives advance.

As a former FDA official, I remain deeply skeptical whenever elected officials or industry stakeholders insist that scientific questions have become so obvious that scientific review is no longer necessary. That’s usually the moment when scientific review becomes most important.

The biosimilar marketplace is growing. Competition is increasing. Confidence is expanding. The system is not perfect, but it is working. Congress should focus its attention on the actual barriers to competition and affordability. It should leave the scientific determinations to the scientists. Because biology has not changed. And Congress has not discovered a way to legislate around it.

Peter J. Pitts is a former FDA Associate Commissioner and President of the Center for Medicine in the Public Interest.

On May 11th, ASBM submitted comments on the FDA’s recently released draft guidance and Q&As aimed at “streamlining” biosimilar development by permitting the use of data from non-U.S.-licensed comparator products and foreign clinical studies in the U.S. biosimilar approval process. While efficiency is important, ASBM is concerned that these changes may lower evidentiary standards in ways that risk undermining physician and patient confidence in biosimilars. 

Biosimilars are safe and effective—but they are not generics. Reducing the role of clinical and pharmacokinetic data too aggressively, while promoting a simplified regulatory approach, risks blurring the scientific distinctions that underpin the biosimilar pathway. ASBM believes that the FDA maintaining a science-based, case-by-case approach is essential to preserving trust in biosimilars and ensuring patient safety.
From ASBM’s comments:

The FDA’s proposed approach to biosimilar approval stands in stark contrast to the rigor traditionally expected of innovator medicines, which must independently demonstrate safety and effectiveness through substantial evidence, generally grounded in well-controlled clinical investigations. For example, in Q.I.8.a, lines 164–168, the draft permits “analytical differences identified in product quality attributes between the non-U.S.-licensed comparator product used in the clinical study and the U.S.-licensed reference product included in the applicant’s comparative analytical assessment,” so long as the sponsor provides “an adequate scientific rationale” for those differences. This language could be read to suggest that if a biosimilar manufacturer offers a plausible explanation for detected quality differences, that rationale may be accepted without requirement to demonstrate its basis in fact. This raises an alarming possibility, as physicians and patients expect confidence in the quality of FDA-approved medicines, not merely adequate or plausible explanations – particularly when those medicines are complex biologics used by patients with serious and chronic conditions.

Maintaining physician and patient confidence in third-party biosimilar substitutions is critical, as biologic treatment is highly individualized and often involves patients with chronic, complex conditions. In ASBM’s national physician surveys[1], 89% of prescribers expressed high confidence in the safety and effectiveness of biosimilars[2], and 88% of U.S. physicians supported maintaining the FDA’s case-by-case approach to interchangeability, but only 11% favored treating all biosimilars as interchangeable by default.[3] This suggests that the FDA’s rigorous, evidence-based framework has been effective at building confidence in biosimilars among physicians, but that confidence could be undermined if biosimilars are treated more like generics without proper, individual evaluation.

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[1] http://www.safebiologics.org/surveys

[2] https://safebiologics.org/wp-content/uploads/2023/08/ASBM-2021-US-Biologics-Prescribers-Survey-Specialty-Data.pdf

[3] https://safebiologics.org/wp-content/uploads/2024/09/ASBM-US-Physician-Survey-IC-Biosims.pdf

Read ASBM’s full comments below:

Read the FDA announcement about the new Guidance and Q&As.

Congress is considering the Maintaining Investments in New Innovation Act (MINI Act) [HR 1672], legislation to protect patient access to genetically targeted therapies (GTTs)—innovative treatments designed to address the underlying genetic causes of serious diseases.

Under current law, some of these therapies may face Medicare price controls earlier than similarly complex treatments, simply due to how they are classified. That shortened timeframe to recover research and development costs risks discouraging investment and limiting future treatment options.

Patients should not lose access to life-changing therapies because of a technical classification issue. The MINI Act would help correct this imbalance and preserve incentives for innovation.

Click Here to Tell Your Members of Congress to Support the MINI Act

ASBM is urging Congress to pass the SAFE Drugs Act of 2026, legislation designed to strengthen oversight of unsafe, unapproved, and mass-marketed copycat medicines. Pharmacy compounding plays an important and legitimate role in patient care when FDA-approved therapies are unavailable or when a patient has a specific clinical need that cannot be met by an approved product. However, in recent years, some large-scale compounding operations have expanded into interstate distribution of products that closely replicate commercially available, FDA-approved drugs—without undergoing the rigorous FDA review, inspection, and approval standards that protect public health. Patients deserve to know that the medicines they receive are what they claim to be—and that they have been made under appropriate safeguards. CLICK HERE to tell your Senators and Representative to support the SAFE Drugs Act. Read ASBM’s letter supporting the SAFE Drugs Act of 2026 here.

ASBM recently engaged on two bills in Colorado addressing oversight of drug compounding and patient safety. The organization supports SB 26-130, which adds targeted safeguards for med spas and other settings handling prescription drugs, helping ensure that these products are stored, handled, and administered safely.

At the same time, ASBM opposes HB 26-1262, which would limit Colorado’s ability to go beyond federal standards to address emerging risks in drug compounding. At a time when concerns are growing about the mass production and marketing of copycat medicines, states should retain the flexibility to strengthen oversight and respond to new safety challenges.

Together, these bills highlight an important policy question: whether states will take steps to enhance patient protections or risk weakening them. ASBM continues to support a balanced approach that preserves access to legitimate, patient-specific compounding while ensuring appropriate safeguards are in place to protect patients.

A recent Washington Post opinion piece details the devastating consequences that can occur when compounded medicines are used without adequate safeguards. The author, who suffered acute liver failure after taking a compounded GLP-1 product, describes a troubling reality: many patients assume compounded drugs are held to the same standards as FDA-approved medicines, when in fact they are not. 

ASBM Advisory Board Members Philip Schneider and Dean Jordan’s recently authored a Washington Times article about the importance of compounding oversight. Read it here.

Learn more about pharmacy compounding at ASBM’s microsite SafeRxCompounding.org

Washington Examiner (Opinion): 
FDA Chaos Threatens Administration’s Drug Agenda and Risks Patient Safety

March 15, 2026 | Dr. Cristina Beato 

The Trump Administration recently celebrated one year of embracing the movement to Make America Healthy Again. Unfortunately, many of these successes are overshadowed by slapdash decision-making at a key health agency, which significantly undermines the Administration’s goals, threatens treatment access, choice, and safety for American patients, and hinders our longstanding reputation as a world leader in medical innovation.

For over 100 years, the Food and Drug Administration (FDA) has played a vital role for American patients and drug manufacturers, establishing rigorous, science-based standards and clear approval processes for lifesaving treatments.  Prior to this year, the FDA has been considered the “gold standard” among global regulatory bodies. This reputation, however, has been severely diminished during the past year by agency decision-making that has left Americans baffled and concerned.

In 2025, the FDA slashed its sizeable workforce by nearly 4,000, but the arbitrary nature of the dramatic reduction in force was evident in the subsequent rehiring of some of those staff members, prompting widespread alarm. Turnover has not been isolated to rank-and-file staff, as the Center for Drug Evaluation and Research (CDER) churned through four leaders over the course of 2025, including cancer researcher and founder of the FDA’s oncology center Richard Pazdur, who would go on to retire a mere three weeks into his tenure. The instability continued when Vinay Prasad (previously fired in July 2025 and rehired less than two weeks later as Director of the Center for Biologics Evaluation and Research) was announced to be departing yet again. This leadership turmoil is emblematic of the broader chaos engulfing the agency.

Pazdur warned earlier this year that the chaos at the FDA has extended to the agency’s approach to its core regulatory functions, and recent developments have unfortunately proven him correct. The guidance coming out of the FDA is not only shortsighted but also often hypocritical and directly self-contradictory.  The FDA’s management has lost sight of its North Star – its commitment to following the science, which previously made it the most trusted regulator in the world. Course-correction is needed to ensure the core functions of safety, efficacy, and affordability of medications, and to regain Americans’ trust.

Take Moderna’s recent experience navigating contradictory and confusing FDA messaging during the vaccine approval process. In February, the FDA refused to review Moderna’s new mRNA flu vaccine due to issues with the company’s comparator study design, which Moderna claimed contradicted earlier agency guidance. After several weeks of industrywide outcry at the decision, the FDA reversed course, but the damage was already done. The refusal came mere weeks after Moderna announced it was not planning to invest in late-stage studies of several experimental vaccines. This short-sighted, undisciplined management undermines America’s leadership in medical innovation and the proven economic benefits that flow from it.

Other manufacturers have similarly faced abrupt rejections of applications for new treatments over clinical trial issues, including a cell therapy for patients with Dechenne muscular dystrophy, a viral-based treatment for patients with advanced skin cancer, and a cell therapy for patients with white blood cell disorder, the rejection of which was a reversalof the FDA’s position over five years of meetings. These mounting inexplicable decisions are daily affecting American patients by delaying treatments, stifling competition for affordable medications, and undermining America’s leadership in scientific discoveries.

While the FDA has begun requiring even more evidence for certain vaccines and some therapies, it has taken the opposite approach for other drugs, including biosimilars, without providing a scientific justification for significant policy changes.  In the fall, the FDA released guidance stating that it would no longer require switching studies that demonstrate that a biosimilar is safe and effective when compared to its reference product. Additionally, the agency recently announced that manufacturers can file for drug approval with one pivotal trial, backed by confirmatory evidence, rather than the two pivotal trials that the FDA has consistently relied on. Senior leadership at the FDA defended the measure, arguing that overreliance on two trials no longer makes sense, and said they expect a surge in drug development in response.

Cutting regulatory requirements on the one hand and increasing them on the other does not inspire faith in the agency’s decision-making. Drug development can take a decade or longer and cost hundreds of millions of dollars. Constantly shifting regulatory guidance will only make companies less inclined to invest in new and innovative treatments. In the case of Moderna’s flu vaccine, President Trump reportedly prompted the FDA’s change of heart. While it is reassuring that President Trump and some in the Administration understand what is at stake, counting on case-by-case presidential intervention is no substitute for steady, predictable standards. The President needs a leader at the FDA who understands its mission and has the ability and prudence to manage this vital agency without unpredictability and dysfunction.

The impact of this dysfunction ultimately falls on American patients. If the FDA’s seemingly arbitrary and inconsistent decisions appear ungrounded in science, the hard-earned public confidence in the medicines it approves will suffer. Further, if the agency’s unpredictability makes manufacturers less willing to invest in incremental and breakthrough innovations, it could delay or prevent these treatments from reaching patients and may even make manufacturers think twice about any investment in the U.S. at a time when our global adversaries are eager to gain any advantage.

If a healthy America is the goal, then patients and manufacturers deserve a steady hand that builds trust and innovation, not continued chaos and confusion.

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.