The main center within the FDA for the evaluation of medication is known as the Center for Drug Evaluation and Research. The center evaluates all drugs before they are sold. It currently evaluates more than 10,000 drugs that are on the market to ensure that highest standards of those drugs. They also monitor media broadcasts to make sure that messages portrayed are truthful to consumers. Lastly, they provide health care professionals as well as consumer’s information pertaining safest and most effective ways to use drugs. There are three phases that the CDER uses when evaluating drug.
The first phase pertains to the initial investigation of a new human drug. These studies are monitored very closely and are sometimes conducted in patients, but are usually conducted most frequently with healthy volunteers. They are designed to determine the metabolic and pharmacological reactions of the drug in humans, and possible side effects of the drug in proportion to dosage. Another reason for this phase is to gain some preliminary evidence on the effectiveness of the drug. During this phase of the research, there should be significant knowledge obtained with regard to the effects of the drug in order to have a second phase that is valid and more in depth. The first phase of study also evaluates the way the drug metabolizes and the potential of activity to affect the performance of the drug. When doing a phase one study of a drug, the number of subjects varies significantly. However, in most phase one studies the number of subjects participating in the study range from twenty to eighty. In the first phase of studies on a drug, the CDER can place a hold on the study for many reasons. Some of the reason may include safety reasons or ethical reasons pertaining to the subjects.
The second phase includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common short-term side effects and risks associated with the drug. Phase two studies often the most well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving several hundred people.
The third phase of drug research is much expanded research in comparison to the previous two stages. There are variables in this part of research that are controlled and there are uncontrolled variables as well. This research is performed after preliminary evidence suggesting effectiveness of the drug has been obtained. The intention of this research is to gather additional information with regard to effectiveness and safety and attempts to be conclusive with answers about the drug as far as benefit/risk issues are concerned. This is also the phase in the drug research process where labels are created and the basic guidelines for definition and public informative information is finalized. These studies may include several hundred to several thousand people.
At any point in time in the research process, CDER can impose a clinical hold if a study is unsafe or if the detail is clearly insufficient in meeting its stated objectives. Great care is taken to ensure that this determination is not made in isolation, but reflects current scientific knowledge, agency experience with the design of clinical trials, and experience with the class of drugs under investigation.
Another thing that the CDER is responsible for doing is approving generic drugs. A generic drug product is one that is comparable to an original drug product and is identified in the FDA’s list of approved drug products with therapeutic equivalence evaluations. They are comparable in dosage form, strength, route of administration, quality, performance characteristics and intended use. A term to be familiar with concerning generic drugs is “ANDA.” This is an abbreviation for “Abbreviated New Drug Application.” These applications contain information that is submitted to the CDER and they provide for the review and ultimately, the approval of a generic drug. When the drug is approved, it may be manufactured and marketed so long as all other patent protection and other issue have been resolved with the original manufacturer of the product. Generic drug applications are termed “abbreviated” in that they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. These parameters were established upon the approval of the innovator drug product, which is the first version of the drug product approved by the FDA.
Process of Approving Over the Counter Drugs
When a package is received in the division of OTC Drug Products, a manager conducts what is called an initial review to determine the type of drug that is being referred to. Then, he or she sends the package to the appropriate team for a more detailed review. The leader of that team determines if the package will need to be reviewed by other consultants or be reviewed in other divisions. (For example, a chemist or biologist may be necessary in review of a product) Then after all of this is completed, the package is then forwarded to someone else for more extensive review. If the data submitted is a comment or opinion on a specific rule or policy, there is no deadline established for CDER to respond. However, if the data is a petition or request to amend or change a policy, or request to have a drug approved based on an existing policy that is spelled out, the OTC division has 180 days to review the data and respond to the sponsor.
When the data is reviewed, the drug is categorized through the rulemaking process as follows:
Category I – generally recognized as safe and effective and not misbranded.
Category II – not generally recognized as safe and effective or is misbranded.
Category III – insufficient data available to permit classification. This category allows a manufacturer an opportunity to show that the ingredients in a product are effective, and, if they are not, to reformulate or appropriately re-label the product.
CDER also oversees OTC drug labeling because the safety and effectiveness of OTC drug products depend not only on the ingredients but also on clear and truthful labeling that can be understood by consumers.
The CDER is always responsible to inform the producer why the product did not meet the standards set forth by the FDA. If the producer questions or disagrees with the results of the CDER, there are ways in which to approach the issue to have it evaluated further. While the CDER is the final authority on whether or not a product is marketed, they are fair in their evaluation and decisions with regard to products.
FDA Evaluation of Medication
