Getting a prescription drug approved by the Federal Drug Administration (FDA) is a lengthy process that requires many safeguards for consumers, to protect them against ineffective or hazardous medications. In many cases, the use of clinical research organizations is employed to help facilitate the approval process, instead of the company employing its own research department. Here is the process that prescription drugs must go through before they are approved by the FDA.
Pharmaceutical Companies Undergo a Rigorous Process of Approval
The process for prescription drug approval is different than the process for approval of over-the-counter drugs. Prescription drugs must go through a pre-trial clinical research in the laboratory and on animals, before study can begin on human subjects. Clinical trials on humans must be done to ensure that the product ingredients are safe, that the medication works as it is supposed to and that long-term effects are taken into consideration. These studies can take many years to complete.
Clinical trial subjects are generally followed over a period of time and are medically supervised for side effects and other issues. Sometimes, multiple drug trials are needed to provide a safe and effective product. A full service clinical research organization is often used to assist in this research, both to reduce costs and to ensure proper procedures.
Generic Drugs Approval Process
After the patent on a prescription medication has run out, other companies are free to produce a generic version of the drug. These companies do not have to repeat the original testing that allowed the original company to receive FDA approval. They undergo an “abbreviated process” that involves ensuring that the drug they manufacture enters the bloodstream similarly to the original drug and gets there in approximately the same amount of time. In this way, the consumer can rely on generic drugs having the same medicinal effects as brand name drug.
The FDA Carefully Reviews All Data Regarding the Drug
The data is then sent to the FDA, where physicians and scientist review the data from animal and human trials. They ensure that the manufacturer of the drug can properly and safely produce it for the marketplace. They assess the human and animal trials. They also review proposed labeling for the drug, to ensure that both physicians and patients are aware of any side effects or problems related to the drug. If all this data is satisfactory, the FDA will then approve the drug for sale to the public.
Companies that are interested in manufacturing medications for the healthcare market must be committed to the rigorous testing, monitoring and scrutiny needed to ensure the safety of the public. Once FDA approval is given, the manufacturer can then begin the process of wide-scale manufacturing and marketing to bring the medication to the medical community and to the public sphere.