How can we be certain FDA-approved medications are safe for human consumption?

How can we be certain FDA-approved medications are safe for human consumption?

November 30, 2015

Americans spend a lot of money on medicine – nearly $375 Billion last year alone. Whether they’re refilling a prescription, keeping their medicine cabinet fully stocked with their favorite over-the-counter drugs, or feverishly hunting down a flu fix – Americans rely on FDA-approved medications and drug stores to keep them in good form.

Since the passing of the Affordable Care Act, people are filling more prescriptions – 24% more in 2014 than 2013 to be exact, and over-the-counter medication usage is also on the rise by approximately 3%. We know our consumption is increasing; but how can we be certain that all of the medications we ingest are safe?


A comprehensive team reviews every New Drug Application

The FDA evaluates all new drugs before they can be sold. They not only police the industry, but also ensure drug effectiveness and proper prescription by doctors.

According to the FDA, “a team of CDER physicians, statisticians, toxicologists, pharmacologists, chemists and other scientists review the data and proposed labeling.” This unbiased team ensures benefits outweigh any known risks, and ultimately give the product a final approval before it goes to market. 

Animal tests are mandated to assess medication safety

Animal testing typically begins with fish or mice to determine if the medication is safe enough to be tested in humans. Certain fish, like salmon, are similar enough to humans on a molecular level, for scientists to gather plausible causation.

The FDA reviews all animal testing findings and results before making their decision. Provided the medication passes this step, FDA-monitored human trials commence to determine if the drug is effective and safe on humans.

Drug labels address safety concerns, risks and warnings

The label provides necessary information about the drug, including uses for which it has been shown to be effective, possible risks, and how to use it. The FDA has a variety of helpful information compiled for consumers, ranging from side effects risks, to medication guides, to recommendations for frequent travelers.

Clinical trials are an integral part of the FDA approval process

Every clinical trial helps scientists and researchers deepen their understanding of medications and their effects on the body. Clinical studies are multi-stage trials, which determine the following:

  1. Short-term and long-term drug side effects
  2. How drugs are metabolized and excreted
  3. Determine drug’s efficacy in people with certain conditions
  4. Research the drug’s effectiveness is various demographics of the population
  5. Assess dosage recommendations

Participate in a clinical study

At OCRC, we offer a variety of clinical trials and research studies in our state-of-the-art clinical research facility. The Phase I-IV clinical trials that we specialize in test investigational medications being developed by pharmaceutical and biotech companies. All participants receive treatments and medical care related to the trial. Additionally, participants may be compensated for time and travel. Health insurance is never a requirement.

If you are interested in participating, please tell us a little more about yourself in the Contact section of the home page and we will respond to you to determine your eligibility for current and future studies.