Post Launch Activity – How is a new drug developed and tested, even after approval? Know the end-to-end process

This is a question that many of us, as patients or family members of people with rare diseases in particular, ask ourselves. We are often faced with news about the research related to or the launch of new drug therapies. Sometimes, we do not understand the process between the development of a new drug until it used by the patient. Safety is still evaluated after FDA approval by the drug company and is required to be reported to FDA periodically, usually at one year intervals.

Yes, there are regulatory steps to follow:

Every new drug that is going to be launched on the U.S. market has gone through several stages of research and testing until it is approved by FDA. Afterwards, proper Drug post launch activity ensures that the benefits and risks of the drug are known as the newly exposed population(s) uses it for longer periods of time. During the post launch, or postmarketing, process it is the company’s responsibility to track, report, and evaluate the safety and effectiveness. This process is part of pharmacovigilance.

What were the first steps for the development of a new drug?

The first step was the discovery of the drug. Not all discovered drugs are even considered for development or regulatory submissions. There are thousands of compounds and molecules researched around the world. The process of getting an approved regulated drug is long and rigorous for the pharmaceutical industry. New drugs comply with several steps.

Preclinical Research

This step has the objective of verifying whether the drug candidate effective and safe, besides analyzing how the new substance is absorbed by the body and how it is eliminated. Generally, preclinical studies are carried out first in vitro and later in vivo. After the in vivo, animal, stage canidates are conisdered for clinical studies.

Three phases of clinical research

Clinical research involving human beings also aims first to evaluate the safety and then the efficacy of new drugs through data collection. Typically the clinical studies start with research volunteers. There are usually three types of clinical trials finished before FDA approval.

Phase 1: First investigation into the new drug in humans to determine how the drug reacts in the body
Phase 2: Focuses on the clinical effectiveness of the drug and assesses short-term adverse effects related to the safety of the drug
Phase 3: Studies in a large number of patients to further demonstrate safety and effectiveness

Post Launch Drug Activity

As noted, after approval it is the company’s responsibility to continue to evaluate the safety and effectiveness. This is part of pharmacovigilance, looking to see if the benefit/risk has changed with the drug as it is used for longer periods of time, off-label and then in all different types of patients than exposed in the controlled clinical trials. These findings of safety and efficacy are required to reported periodically. These can be submitted for review by FDA prior to the required times if the company chooses.

Phase 4: Studies are clinical studies after drug approval and would be part of the pharmacovigilance and periodic reporting to FDA. Sometimes the preapproval Phase 3 studies are extended to Phase 4 or FDA will request Phase 4 studies for more benefit/risk data.

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