Patient Information, Pharma World

The Patient’s Guide to Understanding the FDA Approval Process

contributed by Kathy Jordan 

Many medical patients might assume that finding the right medication to heal an ailment or cure a disease would be fairly simple. Contrary to popular belief, pharmaceutical companies go through an extensive process before they can even market medications to the general public. The Food and Drug Administration (FDA) has strict guidelines which must be followed to a tee before a medication can be considered safe for public consumption. Failure to comply with such regulations could result in adverse affects for those who consume the medication as well as a great deal of legal trouble for the pharmaceutical company.


FDA Approvals Are Mandatory and Expensive

Before any pharmaceutical company can begin advertising their prescription medications to the general population, the medication must receive a stamp of approval from the FDA. The process to getting an approval can often be very extensive, costly, and time consuming. In some cases, this process can take a decade or more to complete. Statistics show that out of 5,000 medications that make it to the pre clinical phase, approximately five of them will be approved. As such many pharmaceutical companies end up wasting a lot of time and money on drugs that are not successful enough to market.


Understanding the FDA Approval Process

One might assume that if a medication is created it can simply be advertised to the general public. However, the truth is that every medication must go through an approval process that can take several years to complete. Each stage must be a success in order for the medication to be advertised for use. Below is a brief rundown of the approval process.


Pre-Clinical Phase

During this stage researchers look for various compounds that can help to treat various diseases. After discovering a combination of compounds, the researchers must then refine the compounds to the appropriate (tolerable) level for human consumption. To determine such levels the toxicology of the compounds are put to the test using animals and/or living tissue. It is during this stage that medical researchers must determine a dosage level, intake frequency, delivery method (oral, topical, intravenous), and the survival rate of the animals it’s been tested on. This process can take about three to four years to finish.


Submit An Application

After the company has completed all the necessary testing in the pre-clinical stage, an application for Investigational New Drugs must be completed and submitted to the FDA.

  1. Phase One – After the FDA has reviewed the application, the medication must then be tested on humans. The pharmaceutical company is required to test the drug on a healthy group of individuals totaling no more than 100 people. They must observe the reaction of each participant to see how they tolerate the medication. Depending on the amount of participants, this step in the approval process could take as long as a year to complete.
  2. Phase Two – If the drug is handled well by the group of healthy participants, the next step would be to test it on those who have the particular disease or condition the medication was intended for. During this testing phase, researchers must test the drug on a group of 100-300 people. They must see how it is tolerated amongst this group and note any possible side effects. This process again will vary but generally takes approximately two years to complete.
  3. Phase Three – If the drug is successful amongst a group of 100-300 participants it must then be tested on a larger scale. This must include approximately 1,000 – 3,000 participants. Because of the amount of participants in this study, it could take pharmaceutical companies approximately three years to complete this process.

Part Two of the Application Process

After having done all the above testing and analysis, the pharmaceutical company will need to complete a New Drug Application and submit it to the FDA. The application is not to be taken lightly as it is generally around 100,000 pages long. The application will need to include results in each phase of testing to both humans and animals. It will also encompass how the company intends to manufacture the drug. The FDA generally takes about a year or two to review the application and either approve or deny the drug.


Approval and Distribution

If the drug is approved by the FDA the pharmaceutical company will need to market it to the general population. The company will also need to submit periodic reports to the FDA that includes the short and long term side effects on an ongoing basis.

While this approval process might seem time consuming, the hopes are to only produce medications that will benefit the general public. Whether it’s a medication claiming to cure cancer, or a prescription drug such as Lovenox to prevent blood clots, the FDA takes the review process seriously – and for good reason. As a medical patient, if you’re curious about new medications, you can always revert to the labeling on the medication, your pharmacy, or follow up with the FDA for more information.



Looking for special service?
Don't spend time on search!

Place Request Anonymously »

Get applications from providers For Free