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

Latest Developments

We keep our members and partners in touch with the most recent updates and opinions in the worldwide dialogue on population longevity and related issues.

Joe Biden’s ‘Cancer Moonshot’ May be Derailed by New Policies, Including His Own

For almost a decade, President Biden has championed a bold “cancer moonshot” — an initiative he first launched in 2016, revived early in his administration, and reiterated during this year’s State of the Union. It is a laudable goal, especially for an aging nation where cancer and chronic disease are on the rise. There’s just one problem: Recent federal and state policies are poised to derail the incredible progress made in oncology since 2016. A rash of policies now threatens to limit access and slow progress towards new breakthroughs.

Global Coalition on Aging, Leading G7 Government Officials, Call for Incentivized Antibiotic Innovation

The Global Coalition on Aging (GCOA), in partnership with the Japanese Pharmaceutical Manufacturer’s Association (JPMA), and public health leaders call on G7 governments to fund pull incentives and make “fair share” investments in antibiotic innovation to fight the global antimicrobial resistance (AMR) crisis. GCOA, JPMA, and health and government officials from the European Union, Italy, Japan, and United Kingdom recently convened to discuss how G7 countries must respond. GCOA today published a report detailing takeaways from the closed-door meeting, “The Role of G7 Governments in Global Efforts to Encourage Antimicrobial Development Through a Pull Incentive: Challenges and Collaboration.”

Kishida and Biden Face a Similar Demographic Crisis

Your front page story “Japan wrestles with age-old problem as population declines at record rate” (Report, April 13) and the letter in the same edition from Tim Hill, “A gently declining population is no reason to panic”, both describe what all societies face as they modernise in the 21st century.

2024 AMR Preparedness Index Progress Report Highlights Urgent Need For Global Action Against Antimicrobial Resistance

Today, the Global Coalition on Aging (GCOA) and the Infectious Diseases Society of America (IDSA) launched the 2024 AMR Preparedness Index Progress Report. Released in the lead up to the United Nations General Assembly 2024 High-level Meeting on Antimicrobial Resistance (AMR) this September, the 2024 Progress Report assesses how the eleven largest global economies have advanced on calls to action laid out in the 2021 AMR Preparedness Index.

New Global Analysis Across Five Cities Shows Inequities in Adult Immunization Uptake, Signaling Need to Redesign Local and National Policy Interventions

GSK, in collaboration with the Global Coalition on Aging (GCOA), announced a new report from the IQVIA Institute for Human Data Science (IQVIA Institute). The report, funded by GSK, explores the role of social and structural determinants of health in adult vaccine access and uptake across five global cities with strong data about their aging populations: Bangkok, Thailand; Brussels, Belgium; Chicago, US; Manchester, United Kingdom; and New York City, US.

New Report From the Global Coalition on Aging Highlights the Connection Between Adult Immunization and Economic Health in Aging APEC Region

As leaders from across the Asia-Pacific Economic Cooperation (APEC) region convene in San Francisco over the next week, a new report from the Global Coalition on Aging (GCOA) points to investments in healthy aging as a growing economic imperative amid the region’s changing demographics. According to the new report, programs that keep populations healthy, active, and productive – like adult immunization – are increasingly becoming a prerequisite for economic stability and growth.