Is the FDA Approval Process Killing Healthcare Innovation?

» Posted by on Dec 31, 2015 in David DelCollo | Comments Off on Is the FDA Approval Process Killing Healthcare Innovation?

Is the FDA Approval Process Killing Healthcare Innovation?

By the FDA’s own admission, the process for trialing and approving drugs for sale in the United States is incredibly complex and arduous. Most of the promising compounds that begin the clinical trial process fail to win approval. It’s easy to spin this as a good thing by proclaiming, “we don’t want Americans exposed to bad drugs.”

But a growing chorus of policy experts and medical professionals — not just pharmaceutical reps, mind you — believes that the FDA now goes too far. The trial-and-approval process is so tough that many biotech and pharmaceutical companies, particularly smaller, scrappier entities without billions of dollars in capital reserves, simply forgo drug development altogether rather than risk a costly, reputation-damaging failure.

The Basics of the FDA Approval Process

The FDA’s Center for Drug Evaluation and Research (CDER) is the ultimate gatekeeper of the drug approval process. While it doesn’t test drugs itself, it does spearhead a sprawling, meticulous review process that examines every piece of data culled during the development and trial phases to make ostensibly unbiased decisions with drug consumer’s best interests at heart.

The basic procedure for CDER review and approval is as follows:

  • Drug developers conduct internal research to determine whether compounds have promise for particular indications.
  • Developers file patents for the compounds.
  • Developers submit Investigational New Drug applications to CDER.
  • CDER reviews planned clinical studies.
  • CDER grants clearance for clinical studies to begin.
  • Clinical studies typically follow three phases over the course of several years.
  • CDER reviews clinical data and asks for clarification as needed.
  • The FDA issues final approval or denial.

Even the most rapid drug approval processes can take two years or longer. In some cases, the wait is as long as five years.

The Side Effects of Tough Drug Approvals — and Possible Solutions

Experts identify many “side effects” of the lengthy and cumbersome FDA approval process. Three of the most salient are:


  • Patient (and doctor) powerlessness. Many of the world’s most promising drugs remain in the clinical trial phase. Some may never be approved or commercialized. Meanwhile, doctors and patients aren’t able to make informed decisions based on complete understandings of risks and rewards. Doctors should be able to prescribe non-approved medications in life-or-death situations.
  • Long wait periods for seriously ill patients. In a related problem, many seriously ill patients waiting for a particular compound’s approval die before that approval comes through. Shorter wait times would reduce mortality rates.
  • Rare-disorder drugs often don’t see the light of day. Due to the high cost of the approval process, drugs designed to treat rare conditions often fail to make it through to commercialization. Expedited approval for rare-disorder drugs would improve this situation.

Room for Improvement?

The FDA is a highly bureaucratic organization beholden to many different constituencies. It’s not likely to turn on a dime and radically simplify the drug approval process. Frankly, it’s not clear that that’s warranted.

But it’s also not clear that the status quo is tenable. If you’re worried about the drawbacks of an overly onerous drug approval process, do your part and write to your elected representative. You might not singlehandedly change the world, but at least you’ll go on the record as standing for a just cause.