October 27, 2015 Print

Medical science constantly achieves startling new advances in both detecting and curing a wide array of illness, but the U.S. Food and Drug Administration (FDA) acts as a politicized bottleneck that prevents doctors and patients from choosing their own balance of risk and benefit. The FDA review process takes years, a time during which the bureaucratic system is largely divorced from the immediate concerns of patients who desperately need promising new methods and technologies to thrive, or merely to survive. That’s why Atlas Network partner the Manhattan Institute for Policy Research launched Project FDA, which recently ran a full-page ad in the New York Times arguing for a streamlined process of moving new drug development tools like “biomarkers” into active medical use.

“Everyone will be a patient someday,” the New York Times ad begins. “We live in an era of breathtaking medical breakthroughs. Diseases that were once death sentences can now be managed or cured. The powerful combination of advances in biotechnology and precision medicine promises even more. ‘Biomarkers’ can provide keys to our individual biology, guiding specific treatments to those who can benefit from them. They are already helping us win our battles against cancer and HIV — and are vital to better treatments for millions of patients battling diabetes, Alzheimer’s, and Parkinson’s.”

The ad goes on to call for an external advisory network consisting of experts from both the scientific and patient communities, so that the needs of patients will be at the forefront of the review process — echoing recommendations previously made by the President’s Council of  Advisors on Science and Technology, the National Institutes of  Health, a report from the National Research Council, and FDA senior staff.

“There are those who believe the FDA should be siloed away from the doctors, patients, scientists and innovators who areat the forefront of developing cutting edge treatments,” the New York Times ad explains. “However, in order to bring lifesaving therapies to patients, we must fully empower the FDA to embrace precision medicine and promote a culture of collaboration with the broader scientific and patient communities. A new golden age of medicine is within our grasp. We believe now is the time to seize it.”