The US Food and Drug Administration (FDA) has a number of rules and regulations in place to ensure that prescription drugs are as safe as possible before they hit shelves and doctors start prescribing them to patients. The path to approval is a long and often arduous one that was designed to protect consumers; however, even the safest drugs can be dangerous if they are abused. According to the National Survey on Drug Use and Health, 6.1 million people over the age of 12 took prescription drugs for nonmedical purposes in a 30-day period in 2011.

Some drugs are developed for one purpose but turn out to be effective at treating something else. For example, the BBC reports that Viagra, a drug that doctors prescribe to treat erectile dysfunction, was originally developed to treat angina. Today, it is one of the most prescribed drugs in the world.

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How Prescription Drugs Are Approved

This step-by-step article details the process of prescription drug approval and explores how the FDA’s Center for Drug Evaluation and Research (CDER) strives to protect Americans from potentially dangerous products. In addition to making sure prescription drugs that reach the market are safe, CDER also ensures that they are effective.

Step 1: Conduct preclinical testing.

According to the FDA, all drugs must undergo preclinical testing in a laboratory before developers can submit a New Drug Application or, if the drug is made out of biologic material, a Biologics License Application. In the application, the developer must detail the drug’s test results, manufacturing capabilities, and proposed label for the final product, which contains information on the drug’s various uses, as well as on any possible side effects that might occur.

Developers must conduct testing before submitting an application so they can list as much information as possible on the proposed label. Animal testing requires a significant amount of time and resources, and most drugs that undergo preclinical testing never even make it to the human testing phase.

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Step 2: Submit an Investigational New Drug Application.

If developers manage to produce a drug that shows promise during the preclinical testing phase, the next step is to submit an Investigational New Drug Application. Sponsors of the drug, which might include research institutions or companies, must provide the FDA with the results of the animal testing. They must also explain how they want to conduct human testing. At this point, the FDA will decide if it is fairly safe for them to move forward with the development of the drug.

Step 3: Get approval for a clinical trial from a local Institutional Review Board.

If the FDA determines that development of the drug can continue, a local institutional review board consisting of scientists and individuals who oversee research must approve the clinical trial protocols, which should include:

  • The kind of people who are eligible to participate in the clinical trial
  • The schedule of procedures and tests
  • The dosages that will be studied
  • The duration of the study and its ultimate objectives

The review board is responsible for ensuring participants give consent to those conducting the study and that they are aware of all the potential risks. The review board must also ensure the researchers take all necessary precautions to protect subjects.

Step 4: Conduct clinical trials.

There are typically three phases of testing during clinical trials. Phase 3 hinges on the successful completion of phase 2, which depends on the success of phase 1. This is what occurs during each phase:

  • Phase 1: The initial studies usually rely on healthy volunteers. The goal of Phase 1 is to determine what the drug’s most common side effects are and how the body metabolizes and excretes it. There can be anywhere from 20-80 participants in Phase 1, and researchers focus on the drug’s overall safety.
  • Phase 2: If Phase 1 does not reveal any dangerous levels of toxicity, Phase 2 will commence. The emphasis of Phase 2 is effectiveness. Researchers aim to gather data on whether the drug works for individuals who are suffering from the disease or condition they are trying to treat. In controlled trials, participants who take the drug in question are compared to similar patients who are taking a different drug or placebo. Researchers continue monitoring the safety of the drug and the most common side effects. There can be anywhere from 30-300 subjects who take part in Phase 2.
  • Phase 3: At the successful completion of Phase 2, the FDA will meet with the drug’s sponsors to determine how to conduct Phase 3. The studies during this phase are intended to gather more information about the safety and efficacy of the drug, including how different dosages affect different populations and how the drug interacts with other substances. There can be anywhere from 300-3,000 participants in Phase 3 studies.

If the FDA approves the drug, the sponsor will have to conduct post-market requirement and commitment studies to gather more information about the drug’s optimal use.

Step 5: Submit a New Drug Application.

Submitting a New Drug Application is the final formal step a sponsor must take in order to get the FDA to approve the new prescription drug for marketing and distribution in the United States. The NDA must include all data on the animal and human trials, as well as information on how the drug is manufactured.

The FDA has 60 days to accept the application so it can be reviewed. The FDA can refuse an application that is missing data from required studies. CDER usually reviews and acts on standard drugs within 10 months of receiving the application and on priority drugs within six months.

The number of new drugs that the FDA approves each year has remained relatively stable. For example, they approved 22 New Molecular Entities in 2006, 18 in 2007, 24 in 2008, 26 in 2009, and 21 in 2010.

Then Comes the Hard Part: Selling It

Getting a new drug approved by the FDA is a rigorous process, and the clinical trials alone can take months or even years to conduct, which requires a significant investment in both time and money on the part of the sponsor. One way to increase the demand for a new drug and recoup development costs upon release is direct-to-consumer advertising, which is a contentious topic in the medical industry. According to the World Health Organization, America and New Zealand are the only two countries in the world that allow DTC advertising. Whether it does more harm than good is still up for debate, but there is no doubt that the FDA strives to ensure any drugs that are advertised are as safe as possible.

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