The key form in the drug approval process—used since 1938—is the New Drug Application, which is submitted by the manufacturer. The application, which contains data gathered during human and animal testing, is reviewed by a team of physicians, statisticians, chemists, pharmacologists and other scientists from the FDA; this team also reviews the proposed labeling of the drug.
According to the FDA, the New Drug Application provides enough information for the FDA to determine if the drug is safe and effective, and whether its benefits outweigh its risks; whether the drug’s labeling, including its package insert, is appropriate; and whether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s
identity, strength, quality and purity.
“The documentation required in a New Drug Application is supposed to tell the drug’s whole story, including what happened during the clinical tests; what the ingredients of the drug are; the results of the animal studies; how the drug behaves in the body; and how it is manufactured, processed and packaged,” according to the FDA.
Generic Drug Approvals
Generic drugs are subject to an Abbreviated New Drug Application. The abbreviated application does not require preclinical or clinical data to establish safety and effectiveness. Instead, an application for a generic drug must scientifically demonstrate that the product is bioequivalent to the innovator drug.
The FDA reports that one way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which is then compared to the innovator drug. The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the innovator drug.
Federal law allows brand name companies to apply for up to five additional years of patent protection for the new medicines they develop to make up for time lost while their products were going through the FDA approval process. Brand name drugs are subject to the same bioequivalence tests as generics upon reformulation.
Over-the-counter drugs are defined by the FDA as drugs that are safe and effective for use by the general public without seeking treatment by a healthcare professional.
There are more than 300,000 over-the-counter drugs being marketed in the U.S. today. The FDA reviews the active ingredients and the labeling of more than 80 therapeutic classes of drugs, such as analgesics or antacids, instead of the individual drug products.
For each category, an over-the-counter drug monograph is prepared and published in the Federal Register. These monographs outline acceptable ingredients, doses, formulations and labeling, and can be found in section 300 of the Code of Federal Regulations. The Office of Drug Evaluation IV, under the Center for Drug Evaluation and Research, is primarily responsible for reviewing over-the-counter drugs. Additionally, the Nonprescription Drug Advisory Committee meets regularly to help the agency in evaluating issues surrounding these products. The FDA has cited this committee as playing a major role in the growth of prescription to over-the-counter switches in recent years.