Why are some prescription drugs approved and not others?

Why are some prescription drugs approved and not others?

October 28, 2015

For many Americans, daily drug dosages are a way of life. They wake up, pour a cup of coffee and start the day with a dose of medication to help improve their mobility, mood or cognition. A variety of different ailments plague our population, but the most frequently prescribed drugs are:

  • Analgesics, a.k.a. painkillers
  • Antihyperlipidemic agents: for treatment for high cholesterol or heart
  • Antidepressants: for the treatment of depression or other mood-altering disorders

Hundreds of new drugs are created every year, yet only five out of every 5,000 drugs will make it to your local drug store. There are myriad reasons for this disparity that will be summarized in this article.

The FDA holds research drugs to strict standards.

The FDA has been reviewing drugs for over 100 years. The Federal Food and Drug Act of 1906 has been amended multiple times, with the most recent amendment requiring all drugs to be reviewed for effectiveness (as well as safety, which was mandated in 1938). In the mid-80s, manufacturers gained more access to generics. This exponentially increased the amount of options consumers have at their discretion.

The FDA holds generic drugs to the exact same standards as brand name medications. Unapproved drugs do not become generic medications. The manufacturer must refine their mixture and restart the approval process. These policies are in place to ensure that whether a medication is brand name or generic, its health benefits unanimously outweigh all known risks.

The drug approval process is comprehensive and rigorous.

After manufacturers develop their proprietary formula, the drug must be tested on lab animals for toxicity. Multiple species are also used to determine the safety and efficacy of the medication. Once this step is successfully completed, a formal application must be submitted.

The Investigational New Drug (IND) application includes results from the initial test, the drug’s composition and manufacturing and plans for human testing. An IND application is also a requirement for interstate distribution.

The drug’s category (commercial vs. research), and type (emergency vs. treatment) are determined and filed with this paperwork. Once the drug received a green light from the FDA, there is a holding time before human trials can begin, requiring the drug sponsor to wait 30 calendar days before beginning a clinical study.

It can take years of testing for a drug to complete clinical trials.

Clinical studies are paramount in determining the safety and efficacy of a new drug. Additionally, the FDA requires all new medications be tested on humans or animals. Researchers may spend years testing a medication and experimenting with dosage, thoroughly examining any potential side effects.

Clinical studies have three phases:

Phase 1: A small group (20-80) of healthy volunteers participate in this phase, which emphasizes safety. Other specialized Phase 1 studies focus on small groups of special patient populations, such as those with kidney disease, liver disease, and diabetes for example.

Phase 2: A slightly larger group participates in Phase 2, which focuses on the medication’s effectiveness. Safety is also continuously evaluated and side effects are carefully monitored.

Phase 3: A large group (1,000+) participates in this phase, which helps researchers gather more information about dosages, and any side effects of the medication when combined with other drugs.

Once trails are completed, the FDA reviews the application and determines a final ruling at a review meeting. If the drug receives the final approval, it is released to the general public. Just 10% of all drugs that start clinical trials will become an approved drug.

Learn more about the clinical study process. 

The FDA website is an excellent resource about the prescription drug approval process. Another great way to learn more about clinical trials is to take a tour at OCRC. We also offer tours to volunteers who meet study criteria at our clean and stress-free space located in sunny Orlando, FL.

At Orlando Clinical Research Center, we offer a variety of clinical trials and research studies in which you can participate in our state-of-the-art clinical research facility. We are committed to following extensive safety precautions to ensure the wellbeing of our volunteers. 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.

Learn more about OCRC’s clinical trial process here.