FDA Approvals: On a Fast-Track to Disaster

By Caila Brander, NWHN Policy Fellow

Most of us want to be confident when we start a newly prescribed treatment that the medication we take will improve the ailment we seek to treat. We believe that our drugs have been tested and proven effective. We assume that the U.S. Food and Drug Administration (FDA) verifies that any drug that hits the market is safe…

…Or does it?

Roughly a decade ago, the FDA caved to pressure from Big Pharma and created accelerated or “fast-track” drug approval pathways. The FDA will now approve a drug earlier than it normally would so long as the pharmaceutical company conducts larger clinical trials within 3-5 years of the approval.

Here’s the big problem: Fast-tracked drug approvals are often based on “surrogate markers,” which only assess the impact a drug has on a disease’s progression (Did that cancer drug shrink the tumor?), not the drug’s long-term clinical outcomes (Did the cancer drug actually remove the tumor and extend the life of the patient?). Pharmaceutical companies love surrogate markers because they’re faster and cheaper to prove than clinical outcomes. That’s why these larger follow-up trials are so essential to conclusively determine whether these drug are safe and effective.

But what if these crucial follow-up trials never happen?

A study from the Journal of the American Medical Association proved what the National Women’s Health Network feared all along: Big Pharma isn’t holding up it’s end of the deal. The study assessed all of the fast-tracked drugs approved by the FDA between 2009-2013 to see whether drug companies were completing the required safety and efficacy follow-up trials. Shockingly, the study found that 58% of the fast-tracked drugs had at least one follow-up clinical trial delayed by five or more years and some didn’t have any follow-up trials planned at all.

Of the trials that were completed after a drug’s approval, certain drugs were shown to have NO effect on the diseases they were intended to treat. One clinical trial found that patients who took a fast-tracked cancer drug died faster than those who took an alternative.

So why are these drugs still on the market? The FDA simply doesn’t have the resources to vigilantly monitor what happens after a drug’s approval or to hold Big Pharma accountable. On top of that, we are likely to see the FDA allow even more drugs to qualify for fast-tracked approval based on the agenda of the Trump Administration. Trump has repeatedly criticized the FDA for being too slow to approve drugs and he appointed Scott Gottlieb, who has deep financial ties to the pharmaceutical industry, as FDA Commissioner. Gottlieb has been clear about his support for radical changes to the FDA’s regulatory process, including expanding fast-track drug approval pathways. These changes will further undermine the FDA’s ability to ensure that the drugs we are prescribed actually treat our diseases without causing serious harm.

Innocent patients are paying the price for Big Pharma’s greed, both with their funds and with their health. Approving drugs for treatment that haven’t been proven safe or effective for patients jeopardizes consumer safety and could cost people their lives.

As an FDA watchdog, the National Women’s Health Network will not stay silent about this threat to the health and safety of countless individuals and families. We urge the FDA to protect the safety of women and families everywhere by putting consumer protections before Big Pharma’s profits. On Monday, September 18, we will deliver a statement to the FDA exposing the dangers of the fast-track approval process and urging the FDA to protect the safety of women and families everywhere by putting consumer protections before Big Pharma’s profits.

The FDA was created to protect our safety and it must step up and do it’s job, now more than ever. Our lives depend on it.