The Long Journey: How Prescription Drugs are Created
Many questions are raised about the cost, safety, and availability of prescription drugs. To answer these questions, it is important to understand the process for creation of a drug by a pharmaceutical company and approval by the FDA.
How do pharmaceutical companies create drugs?
Pharmaceutical companies create drugs to treat certain diseases that do not have effective treatments already, to treat new diseases, or to create better tolerated products for certain conditions. In some cases, drugs are developed to target a certain disease and later found to work on another diseases. Drugs are initially tested in laboratories and animals. If found to work effectively and safely in animals, it will move on to the testing process in humans. Many drugs do not advance beyond this initial testing phase.
How does a drug go from the lab to being used in people?
The Food and Drug Administration (FDA) oversees the process and the steps the drug company takes to get the drug to market. The review and approval of a drug from creation to use in people is a long, multi-step process. Here’s a simplified summary of the steps involved.
- The pharmaceutical company outlines their proposed study process for human testing in clinical trials in an investigational new drug application (IND) based on animal testing to review initial safety and effectiveness. The FDA reviews this information.
- The company conducts Phase 1 studies (typically involve 20 to 80 people). If Phase 1 is successful, then Phase 2 studies (typically involve a few dozen to about 300 people) are done. If results from Phase I and II studies are found to be safe and effective, then Phase 3 studies (typically involve several hundred to about 3,000 people) are conducted.
- After these studies are completed, the FDA and drug company representatives meet to review the results.
- If the results are found to be successful, then the company may submit a New Drug Application (NDA) as a formal step, asking the FDA to consider a drug for marketing approval in the US.
- After an NDA is received, the FDA has 60 days to decide whether to accept it so it can be reviewed. If the FDA accepts the NDA, an FDA review team is assigned to evaluate the studies on the drug's safety and effectiveness.
- The FDA reviews information that goes on a drug's professional labeling – the detailed information about the drug’s intended use and precautions to be used by healthcare providers.
- The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
- When this information is reviewed and approved, the FDA will approve (or deny) the application based on assessment of the drug risks versus benefits.
After marketing of new drugs, any reported side effects that are noted with use in the general population are reported to the FDA. If significant concerns are noted, they are added to the drug’s labeling. In some very rare instances, the drug may be removed from the market if the side effects are noted to be serious.
How long does this process usually take?
The process for a new drug to be created and approved may range from 10-15 years. Clinical studies alone can take several years.
Are there instances where a drug can move faster to be approved?
In certain instances, the drug approval process can be accelerated. Here are some examples:
- Fast track – drug approval can be accelerated for drugs to treat serious conditions that do not currently have treatments based on favorable early animal or human study information.
- Breakthrough – drugs used to treat a serious condition and early studies indicate that is an improvement over currently available treatment(s).
- Priority Review – The FDA will review an application in 6 months compared to the usual 10-month standard review time if the drug would improve treatment, diagnosis, or prevention of serious conditions.
Summary
In the US, the drug development and approval process by the FDA is a long and careful journey to approve a drug to be available for use.