Is It Safe? How the Drug Approval Process Safeguards Patients
The medical landscape in the late 19th century was very different from what it is today. There were few, if any, safeguards to ensure that the medications sold to patients were safe and effective. Quack medicines were common, running the gamut from entirely inert (flavored water, sugar tablets) to downright dangerous, with even medicines marketed to children composed mainly of alcohol or opium.
In 1906, Congress passed the Pure Food and Drug Act, which established the US Food and Drug Administration (FDA). The Act and the new Administration sought to improve the quality of medicines sold in the US through tighter controls on packaging, labeling, and advertising. Particular dangerous or ineffective substances were outlawed, and federal inspectors were given greater latitude to refer offenders to prosecutors.
Over the course of the 20th century, the powers of the FDA to regulate medicines in the US grew through subsequent legislation, and today, the FDA’s Center for Drug Evaluation and Research requires a tightly controlled regimen of testing and evaluation for every new prescription or over-the-counter drug brought to market in the country.
This month, we’ll look at how the FDA’s new drug approval process helps safeguard patients against ineffective or dangerous medications.
What Drugs Go Through the Drug Approval Process?
According to the FDA, “A drug is any product that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and that is intended to affect the structure or any function of the body.” That definition does not include:
- Dietary supplements
- Vitamins
- Herbals
- Botanicals
- Natural products
These products fall under the purview of the Center for Food Safety and Applied Nutrition and do not go through a specific approval process; instead, they are controlled the same way food products are.
How Does the Drug Approval Process Work?
Getting a new drug out of the laboratory and into pharmacies or onto store shelves is a lengthy, complicated process that can be roughly broken down into four main phases, each containing several steps:
- Preclinical Phase
- Clinical Studies/Trials
- New Drug Application and Review
- Post-Marketing Risk Assessment
Drug Approval: Preclinical Phase
The drug approval process starts with the development of a new drug compound by a research lab or pharmaceutical company. The entity responsible for developing the drug and shepherding it through the approval process is known as the drug’s sponsor. During the preclinical phase:
- The drug sponsor performs animal testing to ensure that the compound is not toxic. By using several species, sponsors ensure that the drug will be safe for human use.
- The drug sponsor then completes an Investigational New Drug (IND) application and submits it to the FDA. This application contains details about the compound, results from animal testing, and a plan for the proposed clinical trials.
- The FDA reviews the IND, and either approves the drug for clinical trials or requests additional preclinical testing from the sponsor.
Drug Approval: Clinical Trials
During this phase, the sponsor conducts clinical trials on human subjects. These trials are conducted in three increasingly large phases according to strict safety and reliability guidelines.
- During Phase 1 of clinical trials, between 20 and 80 healthy volunteers receive doses of the drug in order to ensure that it’s safe for humans to use.
- During Phase 2, hundreds of patients suffering from the condition that the medication is intended to relieve are given the drug in a blind study. These patients’ outcomes are compared against those of similar patients given placebos or different medications.
- During Phase 3, the drug is used more widely in thousands of different patients to test its effectiveness in the general and specific populations, dosages, and interactions with other medications.
Drug Approval: New Drug Application and Review
Once the clinical trials have been completed and the drug has been shown to be safe and effective, the sponsor will prepare a New Drug Application (NDA) for review by the FDA.
- The sponsor will meet with representatives from the FDA to discuss the application and ensure that the drug is ready to enter the last pre-marketing approval phase.
- Following the meeting, the sponsor prepares the NDA. This detailed application includes results from all animal and human testing, a thorough analysis of the results, an explanation of the drug’s function, and the sponsor’s plan for manufacturing.
- The FDA determines whether or not the application is ready for review and assigns a review team to evaluate the research.
- The FDA further reviews the drug’s labeling to ensure it provides healthcare professionals and patients with adequate information for the drug’s safe use.
- Finally, the FDA will inspect the manufacturing facility to check that specific guidelines for quality control are met.
If the application review, labeling review, and inspection are all successful, the FDA will approve the application. If there are any issues with the drug or its manufacture, the FDA will provide a response letter detailing the problems and requiring additional research, new labeling, or improvements to the manufacturing facility.
Drug-Approval: Post-Marketing Risk Assessment
Once the NDA is approved, the drug may be sold in the United States. While the pre-marketing testing is thorough, there’s no way to predict every long-term or infrequent adverse effect of any medication. Therefore, the FDA continues to monitor new drugs for years after they enter the market. This monitoring takes two forms:
- The drug manufacturer must regularly submit safety updates to the FDA, reporting any new adverse effects or drug interactions.
- The FDA also maintains the MedWatch program, a voluntary system that allows doctors and patients to report side effects of a particular medication to the FDA.
How Long Does Drug Approval Take?
Under normal timelines, the entire process – from initial development to marketing – can take as long as ten years. There is a pathway, however, for drugs that treat life-threatening conditions for which no other or few other treatments are available to be approved on a shorter timeline.
If a drug is considered to provide an “unmet need” to treat a particularly dangerous condition, the FDA may approve it based on an accelerated round of clinical trials, allowing the drug to come to market and help patients more quickly.
Do Over-The-Counter Drugs Go Through the Drug Approval Process?
Yes, most over-the-counter drugs go through this approval process. There are some drugs – such as aspirin or antibiotic ointment (Neosporin) that have been widely used for so long that they are now included in an FDA monograph, meaning that new manufacturers can make medicines using these ingredients without requiring a complete review process.
Even many non-medicinal products containing ingredients that affect the body’s function – fluoride toothpaste, sunscreen, and even deodorants – are also regulated as drugs by the FDA.
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