The FDA Approval Process is
Here to Protect You!

The FDA approval process is the route by which all new drugs come to market.  The FDA has the leading role in approval of all new prescription drugs and the approval process shown in the graphic below.  

It is a long, long process and sucks up millions of dollars of drug company R&D money.  Looking at the flow chart below, we might wonder why there would ever be a problem with an FDA approved drug.  We will go over each step of the journey in the following paragraphs.

FDA Approval process flow chart

A Short Stroll Through
The FDA Approval Process for New Drugs

The whole FDA approval process flows through several stages of the New Drug Development (NDD) process then moves into the
New Drug Application (NDA) flow.  It usually takes about eight and a half years to study and test a new drug before we get to swallow it. 

Seems to me that if it takes 8.5 years to get a drug to me for my illness, by then I've either gotten well on my own, or died or the bug that infected me has mutated into something else.  In which case the new drug won't do me any good anyway.

Pre-Clinical Research

OK, back on track, the NDD phase of the FDA approval process starts with the Pre-Clinical steps involving synthesis and purification, animal testing and institutional review boards.

Before the drug can even start Pre-clinical, the FDA must receive data showing that the drug is safe for use in the initial, small-scale studies.  The sponsor (drug company) can do that in several ways that we won't belabor here.

A lot of things get examined in the preclinical development stages; notably the drugs toxic and pharmacological effects by performing both in vitro (in the lab...literally in "glass") and in vivo (live animal testing).

Genetic toxicity, absorption and metabolism are also evaluated.  Another is how fast the drug and its metabolites (by-products) are excreted from the body.

Synthesis and Purification

In the Synthesis stage, the activities are aimed at figuring out which chemical compounds must be made and tested to get the hoped for result. 

It can take hundreds or thousands of compounds before the right one is found.  Each compound is added one-at-a-time to enzymes or cell cultures or other concoctions to see which additions exhibit some effect.

Computer simulations are heavily employed but eventually it must be tested within a living being.  The whole process may not involve an invented chemical compound at all but employ compounds made naturally by microscopic organisms. 

Various witches’ brews called fermentation broths, with one organism per broth, are tested for the desirable effect.  This approach can involve 100,000 unique broths to be tested.

In animal testing, drug companies make the effort to use as few animals as possible but nevertheless, at least two species of animals are needed, one rodent and one non-rodent. 

It is possible that a drug may react differently from one species to another.  The same milestones are checked as with humans; how much is absorbed into the bloodstream, how it is broken down in the body, its toxicity, its breakdown products and how fast the drug and its metabolites are excreted from the animal.

Institutional Review boards (IRBs) are people focused.  They are structured and convened to protect the rights and welfare of the people participating in clinical trials throughout the entire process.

Clinical Studies

Prior to beginning clinical trials in the FDA approval process, meetings are held between the FDA and the drug company to go over evidence that the compound is biologically active and reasonably safe for administration to humans.

Phase 1 Clinical Studies

Phase 1 Clinical Studies are where the new drug candidate is first introduced to humans. 

Usually the tests are done on healthy volunteers in order to determine the metabolic and pharmacological actions, side effects associated with increasing doses and gain early evidence on effectiveness. 

The number of test subjects depends on the drug but is usually between 20 and 80 people.

The FDA's Center for Drug Evaluation and Research (CDER) who oversees the testing can stop the study from proceeding or stop it altogether for reasons of safety.

It can also be stopped because the drug company failed to accurately disclose the risk of the study to investigators.

Phase 2 Clinical Studies

Phase 2 clinical studies focus on the gathering of preliminary data on the effectiveness of the drug for a particular indication in patients with the target disease or condition.  Short term side effects and risks are
also closely monitored.

At the end of Phase 2, another round of meetings is held to determine if it is safe to go forward with Phase 3 and to plan the protocols for the Phase 3 human studies.

Phase 3 Clinical Studies

Phase 3 Clinical Studies are expanded controlled and uncontrolled trials to obtain more information on the effectiveness and safety of the drug. 

More important, the objective is to have an adequate basis for
extrapolating the results to the general public and transmit that information via the physician labeling.

At the conclusion of Phase 3, more meetings are held between the FDA and the drug company to go over the data gathered in the three phases. 

The information presented at the meeting must include a summary of the clinical findings that will be presented in the New Drug Application (NDA), the methods on how the data will be presented and any other information that needs to be discussed.

There are three other mechanisms in the FDA approval process to speed up development for drugs that promise significant benefit over existing therapies for life threatening illnesses. 

Also to provide drugs still in development to desperately ill patients or patients whose condition prevents them from participating in clinical trials. 

These are the Accelerated Development and Review, The Treatment Investigational New Drugs (Treatment IND), and Parallel Track.

NDA Submittal and Review Process

Once the NDA is submitted and accepted for review, it goes through a number of steps including reviews of six areas including: medical, pharmacological, chemical, biopharmaceutical, statistical and microbiology. 

If all the reviews are acceptable; the NDA goes for final action by the director of the applicable drug review division or office. 

This review process takes about 12 months to complete.  That's the good news since prior to 1992 it took 30 months to go through the process

After the director signs an approval action letter, the product can be legally marketed in the U.S.

After plowing through all that, here is the website that describes the FDA's approval process in their own words. It's very tedious reading but it may be of interest to someone.


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