In baseball, the backstop — netting and a wall placed behind home plate — is designed to protect fans without obstructing their view. Hospitals often serve a similar role in shielding patients from harm: stopping what might otherwise get past the catcher without getting in the way of progress.
The FDA and payers are often seen as the main gatekeepers for drug safety. But hospitals, too, serve a protective role. They can and do restrict access to specific drugs — even when those drugs remain FDA-approved and commercially available — based on safety concerns. For example, in July 2024, Children’s Hospital Los Angeles (CHLA) paused its use of Elevidys, a gene therapy for Duchenne muscular dystrophy, while awaiting further FDA guidance. A hospital spokesperson told STAT: “Patient safety is paramount at CHLA and the hospital has communicated its decision with affected patient families while it awaits any further determination by the FDA.” CHLA’s move may be unusual in its publicity, but it’s part of a longer, less visible tradition of hospitals stepping in where federal regulators have yet to act.
In the past, hospitals have restricted access to approved drugs sooner than the FDA, and leading hospital-based clinicians have advocated for FDA action.
Hospitals restricting access to drugs
While most attention focuses on FDA decisions and payer coverage determinations, hospitals and health systems also play a critical role in managing patient access to approved therapies that are commercially available. Through pharmacy and therapeutics (P&T) committees, medication safety committees, and clinical oversight teams, hospitals routinely evaluate the evidence base, safety profile, and cost-benefit balance of drugs. These same institutions that conduct early-phase trials and pioneer new treatments also serve a crucial role in pausing or reevaluating adoption when uncertainty remains. Hospitals are well positioned to detect safety concerns before they become widespread.
In some cases, hospitals may delay adoption, limit use to specific patient subgroups or require clinician review, or impose internal prescribing safeguards well before the FDA updates a label or issues a safety communication. However, these internal decisions typically are not publicized. Unlike FDA warning letters or payer medical policies, hospital formulary decisions and risk-based restrictions are rarely visible to researchers, journalists, or the broader public. This makes it difficult to assess how frequently hospitals act as a frontline safety backstop — especially in the critical window between early real-world signals and regulatory action.
Hospital-based clinicians advocating for FDA action
There are several documented cases where hospital-based clinicians actively advocated to the FDA — through written requests, public testimony, or advisory committee participation — for the withdrawal of a drug or removal of one or more indications. In these cases, such advocacy often preceded and arguably contributed to the FDA’s decision to remove a product from the market or to rescind specific indications.
Darvon/Darvocet (propoxyphene): From around 2005 to 2010, hospital‑affiliated clinicians and safety researchers — often in partnership with Public Citizen — maintained case reports and analyses describing propoxyphene’s cardiac toxicity and overdose risks. These clinician-submitted concerns began years before the FDA’s 2010 withdrawal recommendation and overlapped with subsequent advisory deliberations.
Avastin (bevacizumab): After Avastin’s accelerated approval for breast cancer, clinicians at major cancer centers — including Cleveland Clinic and Memorial Sloan Kettering — raised early concerns about efficacy and toxicity. They submitted letters and presented data at advisory panels. Subsequent FDA deliberations led to formal withdrawal of the breast cancer indication in 2011.
Hydroxyethyl starch (HES) solutions: Beginning around 2011, hospital-based nephrologists and intensivists affiliated with academic systems, including Mayo Clinic and University of Pittsburgh, reported correlations between use of this synthetic colloid and kidney injury and increased ICU mortality. They participated in hearings, published case series, and raised concerns during FDA advisory sessions. The FDA issued boxed warnings in 2013, and HES formulations were gradually withdrawn from the market over ensuing years.
Opana ER (oxymorphone): Starting in 2015, clinicians in hospital-based infectious disease and emergency medicine departments identified injection‑related harms — including HIV and hepatitis outbreaks linked to misuse of reformulated Opana ER. They presented data to public health forums and FDA committees. In March 2017, an FDA advisory committee concluded that risks likely outweighed benefits. By summer, the FDA had requested a voluntary withdrawal, with which the manufacturer soon complied.
While these cases suggest that hospital-based clinicians have played a role in raising safety concerns, the extent to which their advocacy directly influenced FDA decisions is difficult to measure.
Clinicians voice concerns, but institutions are often silent
When hospitals respond to emerging safety concerns, they typically do so through internal safety review processes. Yet when it comes to external advocacy — especially with regulators — hospitals themselves are often silent. Instead, it is individual clinicians who testify before FDA advisory committees, submit written comments, or publish case reports documenting emerging harms. Hospitals frequently refrain from institutional testimony to avoid reputational, business, legal, or political entanglement; they may also defer to their affiliated clinicians’ expertise and perceived independence.
This restraint is understandable. Health systems operate in highly regulated, risk-sensitive environments. Calling for regulatory action — especially to restrict or withdraw a product — can be seen as confrontational, especially when institutions have research contracts, philanthropic ties, or strategic partnerships with manufacturers. Institutional statements also require alignment across legal, clinical, and executive leadership — making them slow and politically fraught.
Still, hospitals should get credit for allowing their clinicians to speak publicly under their affiliation — especially when those concerns are later validated. Supporting advocacy behind the scenes or giving clinicians space to participate in FDA advisory processes is meaningful. But the potential power of institutional advocacy — grounded in their real-world evidence — remains largely untapped. A stronger institutional role — via coordinated comment letters, public safety petitions, or formal participation in advisory processes — could amplify safety concerns and help regulators act with greater confidence when evidence is still emerging.
The backstop we need and want
Hospitals and health systems occupy the front lines of real-world evidence. They are often the first to detect safety signals — through internal data monitoring, clinician observations, and direct patient outcomes — well before these concerns reach regulators or the broader public. Adverse event patterns, unexpected harms, or mismatches between clinical trial results and bedside experience frequently surface first within hospital walls.
This early detection role is growing more important as the FDA increasingly relies on accelerated approval pathways and limited premarket data. When post-approval evidence is sparse and confirmatory trials lag, hospitals can serve as a practical check — temporarily pausing use, tightening internal protocols, or initiating direct communication with regulators.
Importantly, hospitals are not just watchdogs — they are often where innovation originates. From gene therapies to cell-based interventions, many breakthroughs are tested, refined, and deployed first in hospitals.
These institutions don’t aim to block innovation any more than a well-placed backstop is meant to block the view of the game. The goal is safety without obstruction — protecting patients while allowing science to advance, even when FDA oversight lags.
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