5 Drug Safety Issues Surrounding the FDA Approval Process

Last updated on November 4th, 2019

“All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective. Nothing could be further from the truth. We learn tremendous amounts about a product only once it’s on the market and only after use among a broad population.”Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness.

Disturbing Factors in the Approval Process

This is a scary thought. But, drug recalls and serious safety concerns that arise after drug approval have proven Alexander’s comments to be true.

Here are few alarming statistics that support his statement:

  • Issue #1 – Aftermarket DangersRoughly 30 percent of the drugs approved by the FDA between 2001 and 2010 were withdrawn. These recalled medications required either a “black box” warning on side effects or a safety announcement about newly discovered risks. This means nearly a third of the drugs they approved had a “post market safety event.”

    So…does this mean every time we use a drug, we have a one-in-three chance of taking something that the FDA has approved…but shouldn’t have?

  • Issue #2 – Small Test GroupsThe majority of pivotal trials in drug approvals involve fewer than 1,000 patients and last six months or less. For example, antidepressants may only undergo a few weeks of clinical trials, but are then used by patients for years or decades. This rapid pace is faster than the agency’s European counterpart, the European Medicines Agency.

    The FDA is currently facing renewed political pressure to speed up this process even more. At what cost does this pace come? With drugs zipping through the approval system, how can FDA officials understand the addictive nature of the meds? Some are asking if the FDA “does enough to weigh the risk of abuse when it reviews new opioid drugs for market approval.”

  • Issue #3 – Disregard of Other Health IssuesThe FDA often studies drugs in subjects who have only one concern. Outside of the lab, we know people who take medications rarely have just one problem. They may be suffering from depression and chronic pain or have concurrent physical diseases. Additionally, people are often taking more than one drug at a time.

    Unfortunately, common drug trials focus solely on how the medication treats its intended ailment – not on how it may interfere with other conditions or drugs.

  • Issue #4 – Shady FinancingConsidering much of the FDA’s funding comes from drug companies, it can be hard to trust the motives behind approvals. Drug manufacturers pay product fees, establishment fees, and application review fees totaling in the billions of dollars.

    In fact, user fees account for 68 percent of the FDA’s review budget for prescription drugs. Yes, it makes sense for the drug manufacturers to pay for the review process, but if they’re the ones controlling the purse strings, might they also influence the outcomes?

  • Issue #5 – Incomplete Follow ThroughIt’s difficult to discover exactly what problems exist with specific medications. Why? The FDA’s system for reporting drug-related health problems is voluntary.

    “The reports are not verified,” according to an ISMP QuarterWatch report, and reviews of the system have found it to be “filled with incomplete and late information.”

Addressing the Lack of Trust

These are disheartening facts. As the nation suffers under a crippling opioid epidemic, rampant misuse of ADHD medication, and thousands of benzo overdoses each year, where can we turn?

What do you think? Do you trust the FDA? And if you don’t, what steps could the agency take to earn your trust again? Sound off in the comment section below!

Additional Reading:   FDA Okays Another ‘Abuse-Resistant’ Painkiller
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