How Does the FDA Regulate Prescription Drugs?

Within the United States, the federal Food and Drug Administration regulates all prescription drugs. Since the passage of the landmark 1906 Pure Food and Drug Act, they have been responsible for all the medication we take. That law required drugmakers — for the first time — to submit their products for review and approval before they could bring them to market.

But the FDA’s regulation of prescription drugs doesn’t relieve pharmaceutical companies of their liability for damages caused by their products. On the contrary, they’re still required to notify medication users about potential side effects. And, they’re required to monitor for new, previously unknown side effects arising from their products after they’ve been approved for sale.


When they fail in those duties, patients harmed by a given drug turn to a personal injury attorney for help. And even though the FDA works hard to keep unsafe drugs off the market, their regulatory processes can never be perfect. Drug injury attorneys have a lot on their plate with older drugs now showing new evidence of linking to cancer, pulmonary diseases, hair loss, and other health issues.

The FDA’s regulation of prescription drugs begins with its drug review and approval process. That process includes several steps that drugmakers must go through to prove that a new drug is beneficial and reasonably safe. If they succeed, the FDA will grant its approval for the drug.

The FDA’s Drug Approval Process

When a pharmaceutical company wishes to bring a new drug to market, the FDA makes them go through a rigorous approval process first. Its purpose is to prevent drugs that could harm patients from becoming available to the public. And approval is by no means a given. To its credit, the FDA often rejects drugs it deems too risky. Here are the phases of the process.

Investigational New Drug Application

The first step in the approval process requires the drugmaker to file an investigational new drug (IND) application with the FDA. The application contains relevant data from animal testing of the drug and a detailed plan for human trials. It must also describe what the new drug is supposed to do, what benefits it should provide, and what conditions it’s meant to treat.

Clinical Trials

If the FDA grants a drug IND status, the next step is for the manufacturer to carry out the human trials described in their IND application. There are three phases to the clinical trials required for any new drug.

The first phase is for the manufacturer to figure out the appropriate dosing of a drug. It’s also when the manufacturer collects data on how humans metabolize and excrete the new drug and documenting any acute side effects.

The second and third phases are when the manufacturer uses its findings from the first phase to study the drug in ever-larger groups of people. Again, the goal is to collect enough data to prove that the drug works as intended and doesn’t have any unacceptable side effects.

New Drug Application

With the clinical trial data in hand, the next step is for the manufacturer to file a new drug application (NDA). It includes that data and a complete description of the drug and how it’s to be mass-produced. It also lists the conditions the drug is meant to treat and labels the information to inform consumers about it.

Final FDA Review

Each NDA gets a thorough review by the Center for Drug Evaluation and Research (CDER). Their staff checks the data from the clinical trial, visits proposed production facilities, and checks that the drug’s proposed labeling is accurate. The CDER is a subdivision of the FDA and is the primary gatekeeper between pharmaceutical companies and the public.

If CDER determines that the NDA has satisfied all its requirements, the drug is approved for sale. Approvals, however, may come with stipulations. For example, the FDA might require the manufacturer to conduct a fourth clinical trial phase post-release. It also might place restrictions on who may use the drug and specify specific warnings for its labeling.

How the FDA Regulates Drugs Post-approval

As previously mentioned, the manufacturer’s responsibility for a drug doesn’t end with an FDA approval. And FDA employees continue to monitor approved drugs once they’re in wide use, looking for:

  • Signals of possible safety problems
  • Manufacturer compliance with approval stipulations
  • New data in relevant post-release research studies
  • Potential review errors in its approval process

The Bottom Line

The FDA’s regulation of prescription drugs involves a thorough pre-release and post-release review and oversight process. But it’s not perfect. As a result, some drugs still come to market, posing a danger to those who take them. And sometimes, those dangers don’t become apparent for months or years after initial approval.

The bottom line is that the FDA does everything in its power to make certain that the prescription drugs available in the US are as safe and effective as possible.

At the end of the day, it’s up to doctors to decide which drugs are worth taking and which aren’t, depending on their patients’ medical status and needs. And it is up to the patients to hold drug manufacturers accountable when they or their loved ones are harmed by the medication they took in good faith to solve their health issues.


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