What to Read: How FDA Can Lead Us Forward

What to Read: How FDA Can Lead Us Forward

02.14.12 | By Kate Connors

In an op-ed published today in the Wall Street Journal, former FDA Commissioner Andrew von Eschenbach writes that America is "on the cusp of a revolution in health care," with the potential for unimaginable advances in the future - but with challenges that might hinder that progress.

Of course, those challenges are many and varied. But the core argument of von Eschenbach's op-ed is the need for the Food and Drug Administration to keep pace with evolving science: "Breakthrough technologies deserve a breakthrough in the way the FDA evaluates them," he writes, somewhat echoing the sentiments expressed by PhRMA's Dr. Alesci when I interviewed him last month.

For example (and forgive the many quotes, but I couldn't bear to leave any of this out):

  • "The agency is broken into Centers dealing with drugs, biologics and devices. Yet increasingly, diagnostic devices will be paired with therapeutics."
  • "The FDA must be capable of ensuring that its reviewers know just as much about advances in emerging sciences as the creators of the products they regulate."

After all, the FDA is, of course, meant to ensure the safety and efficacy of the medicines it reviews, but this is not merely in an oversight capacity - it also means that the agency is also the body that ultimately allows those new medicines to come to the patients that need them. From major diseases that currently stump us, like Alzheimer's, to rare diseases that are just becoming better understood, the need has never been greater. And, excitingly, the science is moving us in the right directions to meet that need.

Interesting, von Eshenbach also makes the point that a stronger FDA won't just benefit the healthcare system, it will also help America's biopharmaceutical industry - "one of the crown jewels of the American economy" - maintain its position as the world leader of the global life-sciences industry.

This, of course, has its own set of challenges, for example from countries such as Singapore and China "already preparing to leapfrog the U.S."

However, von Eschenbach says, if FDA has the tools that it needs to remain the world's gold standard regulatory agency, then the rest - from life-saving medical advances to a platform for economic growth - might just follow.

Follow Kate on Twitter @KateAtPhRMA

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