A Court’s Rewriting of the Drug Development Process Endangers Patients in California

A recent appeals court ruling in California has posed a burning question for regulators, the life sciences industry, and patients. Who should be in charge of developing safe, life-saving medications: scientific experts and the FDA, or judges?


There’s a troubling answer — and disastrous implications — in the ruling, which, if it stands, would endanger patients, undermine health equity, and slow progress towards life-saving medications for the U.S. and the world. In fact, the ruling threatens every field that depends on innovation, from software to the auto industry and aviation.


In a bizarre legal theory, the court found that businesses, including pharmaceutical companies, can face legal action for failing to develop a product, even if it is not proven to be safe or effective. It’s a strange finding that attacks the foundation of a well-established system that has driven incredible medical advances and ensures safe, effective drugs for every American.


The ruling is wrong-headed, even dangerous, for a host of reasons.


First, we already have a government body to regulate drug development. It’s the FDA. The court’s approach effectively challenges the FDA itself, as it preempts and overrides FDA decisions on drug development that already take account of these matters. This is profoundly disturbing and unsettling for its effects on settled national policy relative to drug development.  If every jurisdiction begins to rule on just how fast companies should bring drugs to market, the result will be extremely chaotic and unsafe.


The ruling also ignores the importance of patient safety across the full drug development process. This is a complex, multifaceted, and highly technical effort, which takes years to advance a treatment from an idea in a laboratory to a proven, safe product on pharmacy shelves. Every step of that process is designed to safeguard the patient. If companies are forced to rush through it — based on arbitrary timelines set by judges and lawsuits — it will imperil people’s health, especially for those living with complex conditions like cancer and heart disease.


With this approach, companies may be forced to skip necessary steps in research and development, including thorough clinical trials, which are critical for ensuring a medication is suitable for all patients. Shortened clinical trial timelines can result in an inadequate representation of diverse populations, including Black and brown people who are often underrepresented in clinical trial research.


And as troubling as it is for California patients, the ruling’s effects will not stay contained to the state, or even the country. The U.S. is the world’s innovation engine — responsible for many of the medical and scientific breakthroughs that have enabled the miracle of modern longevity. Just consider the disease in this case, HIV/AIDS, which was once a death sentence but has now become a treatable chronic condition.


If the ruling stands, companies will be actively disincentivized from pursuing similar success stories. After all, what if a judge rules they should have pulled it off faster?


This chilling effect is especially dire in our world of more old than young. We need more health innovation, not less. With an unprecedented one-in-six Americans over 65 — and well over 1 billion people over 60 globally — we need new treatments, vaccines, and strategies to enable healthy aging and mitigate the human, economic, fiscal, and societal impacts of complex, costly age-related health challenges. Penalizing the life sciences sector and upending the R&D process is hardly the way forward.


And finally, why stop with pharma? The court’s logic could plausibly extend to software, cars, AI — any industry where advances save lives. These areas also happen to be precisely those that California prides itself on; the ruling would clearly deter investment in the state.


Whether to treat the most daunting and complex health conditions such as cancer, HIV, and cardiovascular disease, or to advance technology to improve our everyday lives, companies should not be forced to rush the process of creating new and improved products. And ensuring safety and efficacy is especially critical when products directly influence people’s health.


Health equity and healthy aging will not be achieved through rushed R&D or judicial mandate. Science is delicate, and the process to develop safe and effective medicines to treat patients with complex conditions should be managed with care. California’s decision prioritizes speed over safety — a dangerous precedent for our health system, our aging communities, and the life-saving innovations that we all depend on.

Michael W. Hodin, Ph.D., is chief executive officer of the Global Coalition on Aging.

Source: Times of San Diego

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