The U.S. Food and Drug Administration supposedly “implements gold standard science.”
Yet the agency appears to relish obstructing scientific progress. Earlier this month, Vinay Prasad, the director of FDA’s vaccine division, rejected Moderna’s application for a new mRNA flu vaccine for adults 50 and older on dubious grounds. The FDA claimed that the application did not contain an “adequate and well-controlled” trial, but that is nonsense. Not only is the trial consistent with the agency’s current regulations, but the FDA has also been fully aware of the design for more than a year.
Plus, using the same trial process, regulatory authorities in the EU, Canada and Australia are currently reviewing this vaccine, with potential approvals possible as early as this year.
Now, in the face of public backlash, the FDA has reversed course and agreed to review the vaccine. That’s good news for seniors — but doesn’t correct underlying issues with the FDA. The U.S. is currently the global leader in biopharmaceutical innovation and production, but arbitrary decisions from public health officials undermine our leadership position.
By raising unreasonable objections at the last moment, the FDA is acting like Lucy pulling away the proverbial football at the last moment. Only it’s the patients who will end up flat on their backs.
The annual flu poses significant health risks, especially for people aged 50 and older. A paper I recently co-authored estimated that the 2023-24 flu season imposed $29 billion in total health and economic costs. That year, the flu also caused an estimated 28,000 deaths, two-thirds of whom were seniors.
A capricious FDA poses a threat to future medical innovation along with the health and economic benefits that these innovations can create.
Vaccines help reduce these costs. Our analysis found that when vaccination rates for people 50 and older were higher, the number of hospitalizations and mortality was lower.
Put more simply, vaccines make people healthier and save lives.
Derailing a potentially more effective vaccine unnecessarily increases the risk that people will endure severe — perhaps even fatal — cases of the flu.
While current vaccines are essential, there is room for improvement. A better flu vaccine can create even greater protection and lower the chances of adverse outcomes even further. And the proposed Moderna mRNA vaccine can help because, based on the results of current trials, this technology likely provides superior results.
Unfortunately, the damage Dr. Prasad is causing goes beyond flu vaccines. A capricious FDA poses a threat to future medical innovation along with the health and economic benefits that these innovations can create.
The further potential of mRNA technologies exemplifies what is at stake.
These mRNA vaccines are the culmination of decades of basic scientific research that has been occurring since 1985. These therapies help cells produce antibodies or antigens that empower the body to fight the targeted disease. A potential “cancer vaccine” is showing promise for treating pancreatic cancer, lung cancer, breast cancer and prostate cancer.
While the possibilities are exciting, the process is not easy. Developing innovative treatments is a long, expensive and risky process. On average, it takes 15 years to develop a new medicine and costs $2.9 billion (including post-approval R&D expenditures).
Taking all this time and spending all this money does not guarantee success either. Nearly 94% of new drugs entering human trials today are not ultimately approved despite the significant expense that has gone into their development.
Now, on top of all these risks, the FDA is signaling that there is another risk investors may have to worry about — the FDA may arbitrarily change the regulatory requirements on them. Factoring in these risks discourages future innovations in life-saving treatments.
These lost innovations risk the economic benefits and high-paying jobs created by the innovative pharmaceutical industry. They also risk the development of future medicines, such as much-needed treatments for Alzheimer’s and muscular dystrophy.
The FDA is responsible for ensuring drug safety and efficacy, as well as fostering innovation that improves people’s health. It cannot achieve these goals by undermining sound science with erratic and unscientific decision-making — and it’s ultimately patients who will pay the price.