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Navigating the Long Road to FDA Approval

Perspectives from a psychedelics CEO.

Key points

  • FDA approval requires a major investment of money, time, and other resources, but it's an essential effort for developing safe products.
  • Some potential solutions never make it through regulatory approval because comapnies run out of funding.
  • The FDA may encourage the development of alternative testing methods and look for ways to improve.

The long road to FDA approval is a journey undertaken by all drug and food companies aiming to offer consumers safe products that can improve their lives. It requires a huge investment of money, time, and other resources – but everyone recognizes that few regulatory efforts are more important.

My company has been going through the FDA approval process. We entered this development phase with some trepidation but were surprised to find the organization open, friendly, and cooperative. That said, we would hardly be scientists if we didn’t contemplate ways of cautiously improving the process.

Consider the current outcomes: While requiring companies to submit data on lab, animal, manufacturing, and human clinical testing sounds straightforward enough, the success rate for FDA approvals is around 10-15 percent. Last year, out of hundreds of applicants, only 37 new drug approvals were awarded by the FDA.

It’s clearly important to filter out bad drugs, but it is reasonable also to ask whether we might not be filtering out some good ones as well. And that could be the case as some applicants fail not because of outright rejection but because they run out of money, experience execution problems, or encounter other obstacles unrelated to regulation.

The process from application to approval, via clinical trials and scientific review boards, takes 6-12 years – partly because when a failure occurs during one of the phases, trials must start from the beginning. This painstaking review and approval process is critically important before a product hits the market. Still, it can also be a killer for startups struggling with funding whose “runway” is running out.

The protracted timeframe carries two downstream complications: maintaining FDA compliance throughout the proceedings and continuing to recruit patients and keep them in a study during prolonged human testing phases.

Patient selection for the clinical trial phase, designed to explore biomedical or behavioral effects and other impacts, is an especially challenging issue. Since the products generally target a specific ailment, mental or physical, the test subjects must have the relevant conditions and must meet many other criteria.

The search for participants who meet highly specific criteria – and are willing to participate – becomes even more difficult when multiple drugs are being tested for the same condition. The competition can be overwhelming, and it can seem like a search for a needle in multiple haystacks. Add the fact that it is very hard to keep patients in trials over many years, and the problem becomes clear. Some companies maintain multiple recruitment facilities or even outsource the recruitment process altogether. It’s a costly endeavor.

The strictness of the FDA process is understandable; no one wants to produce a product that could be potentially harmful to customers. The FDA’s thicket of rules and regulations aims to provide safeguards that are a moral and ethical imperative, protecting the rights of vulnerable citizens. But despite my enthusiastic support for most aspects of the process, entrepreneurs would certainly welcome it if the FDA authorized some modernization and new methods for creating new drugs in which timeframes were compressed.

My team, for example, suggested speeding up the human trials aimed at testing the efficacy of our psychedelic-derived compound MEAI in treating alcohol use disorder. The FDA ultimately rejected our proposal to skip the testing phase on non-alcoholics and move straight to the target audience – but we appreciated the openness to discussing the matter.

Indeed, we sense the FDA is encouraging the development of alternative testing methods and looking for ways to improve. One path forward is evident in a law signed by President Biden last December that eliminates the requirement that drugs in development must undergo animal testing before being given to participants in human trials. If this is widely implemented, it should allow us to get safe drugs to market more quickly. Such shortcuts might be deemed plausible in searching for mental health remedies, which should be a priority in the coming years.

It can be frustrating dealing with a slow bureaucracy. But we never lose sight of the fact that the exercise is aimed not at making things difficult for companies but at protecting patients. Moreover, keeping bad drugs off the market is ultimately a form of protection for companies and their investors as well. While we may not exactly be on the same team, the FDA and companies like mine actually do share the same goal: helping to improve global health and wellness in a way that is safe.

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