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Spangenberg Shibley & Liber LLP | May 12, 2016

How Does the FDA Regulate Prescription Drugs?

Categories: Product Liability, Defective Drugs and Medical Devices, Articles

The First Steps

  • The first step for a company seeking approval to sell a new drug is to perform laboratory and animal tests to learn how the drug works, and whether or not it will be safe enough for human use. They then submit an Investigational New Drug Application (IND) to the FDA, which needs to be approved before human testing can begin.
  • Next is a series of clinical trials in humans in three phases, all monitored by the FDA, to further test the effects and safety of the drug.
  • The final step requires the company developing the drug to send its data from all of their tests to the FDA’s Center for Drug Evaluation and Research (CDER) in a New Drug Application (NDA). A team of CDER physicians, statisticians, toxicologists, pharmacologists, chemists, and other scientists review the data and proposed labeling to establish if its benefits outweigh its known risks for its proposed use.

Hitting the Market

If the drug clears the review process, then it is approved for sale. Once it’s on the market, the FDA continues to monitor its performance in a number of ways. One of the ways is through MedWatch, the FDA’s safety information and adverse event reporting program. MedWatch receives reports of suspected side effects from consumers, health care practitioners, and pharmaceutical companies, and has access to databases that collect information on prescription drug use and its outcomes.

A Drug Safety Communication may be issued to consumers and healthcare professionals if an unexpected side effect is detected, and a statement will be added to the drug’s label updating the side effects. If the new effects are determined to be dangerous enough, the drug may be pulled from the market altogether.

The Limitations

  • Sample size during human trials is usually small in comparison to the number of people who may use the drug once it hits the market, which makes it difficult to detect rare side effects.
  • Drugs are often taken by sick people already on other medications, making it difficult to predict how the will react to the drug.
  • The drug’s effect on patients may change over the course of years of treatment.
  • While there are hundreds of thousands of adverse side effects reported to MedWatch every year, the service is voluntary and there may be serious reactions that are never reported.
  • The U.S.’s healthcare system isn’t integrated, so there’s no standard way to track the adverse effects medicine may have in a given health system, or across different health systems. Health insurance databases can be helpful, but are only accurate as long as a patient is enrolled with the same insurance system, limiting the FDA’s ability to monitor the safety of medications taken over many years.
  • The FDA, through its Sentinel Initiative is working to develop the capabilities necessary to use data from different health systems to better understand the safety of drugs in clinical practice.

The FDA constantly reevaluates drugs as new information comes to light, but no matter how much data is available, it often comes down to a judgement call based on weighing the benefits and risks of a drug.

Prescription drugs are not to be taken lightly, given the dangers of addiction and overdose deaths. The Centers for Disease Control (CDC) reports that sales of prescription drugs as well as overdose deaths involving opioids have quadrupled since 1999. From 1999 to 2014, more than 165,000 people have died in the U.S. from prescription opioids overdoses.

The Food and Drug Administration (FDA) has an initiative to tell consumers about the decisions involved with the safety and effectiveness of FDA-regulated products. They have a series of articles about the data and methods the FDA uses to determine whether or not products are safe for doctors to prescribe, and can be found here.

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