The FDA Drug Approval Process for Colon Cancer Drugs

The FDA drug approval process for colon cancer drugs is more important than most people know. This process is responsible for determining whether or not a drug can be marketed to the general public, and determines its safety.

The approval process isn't perfect, of course. This is why there are controls to remove drugs from the market.

Overview

The FDA is responsible for the safety and effectiveness of all drugs in the United States. A drug company develops an innovative treatment and then gives a huge file called a New Drug Application to the FDA. FDA examines the application- it can be as large as 500,000 pages -and decides if it's OK to approve this medication.

The drug can be sold only after it meets all FDA requirements. However the specific details about exact label words haven't been worked out yet so the drug may still not be available for patients.

Additional FDA clinical trials may be required and specific information about labeling and use. This permits the FDA to determine the:

• drugs interaction with other drugs
• possible side effects
• effects on particular segments of the population and other details

FDA approval will either be extended or denied eventually. FDA approval news will go to the company, telling them of the status of the drug. If it was approved, the drug may now be officially marketed.

The amount of time it takes for a given medication to go through this process varies significantly. Drugs which are not innovative and have little life saving potential may take 10 years to get through the approval process.

However drugs with new approaches to problems and significant potential to save lives are often put on the fast track to approval. They can be approved within six months of their NDA submission, but it may take the company 5 years of testing before they can get to that point.

Clinical Testing

Animal testing is used for the initial stages of the FDA drug approval process. These tests determine the toxicity of a drug and the chances of its effectiveness in humans. At least two different types of animals are used in the tests.

This rules out the danger of there being problems which don't turn up in 1 animal, like a mouse, but do turn up in some other animal, like a dog. The drug moves into human testing only after the animal tests have been performed.

Each drug must go before a clinical review board before clinical trials with people can begin. This board reviews the early results and makes recommendations on how to proceed. It also certifies that the human studies are being done ethically. Human trials start if the drug passes the review.

Phase I

Phase I of human clinical trials represent the first time a drug in development is tested on humans. These may be healthy volunteers or they may be patients who have been unable to receive conventional treatment. Colon cancer drug trials usually start with patients who can't get regular treatment for some reason. These studies are intended to show how the drug acts and whether or not it has significant side effects. When possible Phase I studies are used to show effectiveness. Because this is the first time the drug is used in people, these studies are quite small, maybe twenty to eighty people.

Phase II

Phase II clinical trials are used to determine how effective the drug is for treating patients who have a particular condition or disease. They also help discover common risks and side effects in the short term, and are done using a wider range of people. They may involve several hundred patients to get a better cross section of the population.

Phase III

Phase III clinical trials may begin after a drug has been through the first two phases of testing. These are conducted to provide more information about the safety and effectiveness of the new drug or treatment. Even more people participate in these - from a few hundred to several thousand in most cases. Phase III studies allow scientists to extrapolate results into the general population.

Formal Application

A drug's sponsor makes the formal application to the FDA, called a New Drug Application.

• It must include analyses and results from both animal and human testing.
• It must also include a description of the methods used to manufacture the drug.

All information must be provided in enough detail to allow FDA reviewers make the most critical decision - do the benefits of the drug outweigh its risks. The FDA must also determine:

• Is the labeling information on the drug is appropriate for its uses and risks?
• Do the manufacturing methods ensure that the drug is pure and uncontaminated by other substances?

This process can take a very long time - on average eight years. Efforts to reduce the amount of time required to get through the process are in progress and have been made year after year for over 40 years. But they are complicated by the fact that the science of finding small problems keeps getting better and more expensive- and no one wants drugs unless they have higher and higher levels of safety and effectiveness. That is what keeps making the process longer and more expensive.

At the Cancer Centers of America you will receive treatment that incorporates the needs of the whole person:

Written by Grace Palmer - 9/1/09

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