Is the FDA too bureaucratic for new drug approvals?

A key barrier to innovation in drug development isn’t manufacturers’ ability to charge exorbitant prices; it’s the ever-increasing cost of navigating the FDA’s approval process. Innovation drives lower prices for valuable goods and services in the rest of the economy, but the FDA may be too bureaucratic to change.

We should reduce red tape at the FDA and enable more drugs to reach patients after compelling midstage clinical trials. We already do this for cancer and HIV, and there’s no reason we shouldn’t do it for chronic diseases when scientifically appropriate, but problems persist.

According to STAT news, the Food and Drug Administration’s accelerated approval pathway was created more than 30 years ago to support the speedy development of HIV treatments. However, 80% of accelerated approvals are now granted to cancer drugs. New research shows that half of those cancer drugs are approved via accelerated approval.

Can AI help?

One of the main advantages of AI-designed drugs is that they can significantly reduce the time and cost invested in drug discovery and development by sponsors and CROs. Approving a new drug developed using traditional methods can take 10-15 years and cost billions of dollars.

There has been much discussion recently about how artificial intelligence and machine learning (AI/ML) will revolutionize pharmaceutical research. Substantial progress has been made in the discovery and identification of new drugs enabled by AL/ML. Now, the clinical testing process is being revitalized by advances in technology. The US Food and Drug Administration (FDA) is paving regulatory groundwork with a new discussion paper regarding AI/ML in drug development.l fail to improve patient survival or quality of life in subsequent clinical trials after more than five years of follow-up. The findings add to a growing conversation about when and how the pathway should be used.

But what about drug approvals?

80% of accelerated approvals are granted to cancer drugs. New research shows that half of those cancer drugs approved via accelerated approval fail to improve patient survival or quality of life in subsequent clinical trials after more than five years of follow-up. In other words, something is wrong with the approval process.

Granted that there are too many “me too” drugs that don’t require an in-depth approval process, but what about drugs that can change patients’ lives? Should they take a year to approve and cost a small fortune? Can AI help speed approval and identify potential problems?

As a DTC marketer, I’ve always been puzzled by FDA studies on how people use and use pharma DTC ads. The choice of medication is a complex journey, and it’s not rational. In addition, DTC ads are becoming less effective as trust in significant pharma declines. As before, more people trusted their doctors to prescribe what was best for them.

Trust in government is at an all-time low. The FDA needs a leader who can transform the agency into a more responsive branch of government. They need to earn back the public’s trust and help lower the costs of new drug approvals.