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.
