Question

The Kefauver Amendments of 1962 to the Food Drug and Cosmetic Act added requirements except:

a. All drugs must be safe and effective, including all drugs approved by FDA since 1938

b. Drug manufacturers must collect safety information once a product is approved

c. New drug approvals were for a five year period and had to be renewed every five years to remain on the market

d. New drugs require FDA consent when they are studied before approval during what would be known as the IND phases

Answer 1

The Food and Drug Administration (FDA) is a regulatory agency within the Department of Health and Human Services. A key responsibility is to regulate the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases: preapproval (premarket) and postapproval (postmarket). FDA reviews manufacturers’ applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. The agency continues its oversight of drug safety and effectiveness as long as the drug is on the market.
Beginning with the Food and Drugs Act of 1906, Congress has incrementally refined and expanded FDA’s responsibilities regarding drug approval and regulation.

The progression to drug approval begins before FDA involvement. First, basic scientists work in the laboratory and with animals; second, a drug or biotechnology company develops a prototype drug. That company must seek and receive FDA approval, by way of an investigational new drug (IND) application, to test the product with human subjects. Those tests, called clinical trials, are carried out sequentially in Phase I, II, and III studies, which involve increasing numbers of subjects. The manufacturer then compiles the resulting data and analysis in a new drug application (NDA). FDA reviews the NDA with three major concerns: (1) safety and effectiveness in the drug’s proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure the drug’s identify, strength, quality, and identity. The Federal Food, Drug, and Cosmetic Act (FFDCA) and associated regulations detail the requirements at each step. FDA uses a few special mechanisms to expedite drug development and the review process when a drug might address an unmet need or a serious disease or condition. Those mechanisms include accelerated approval, animal efficacy approval, fast track applications, and priority review.

Once a manufacturer completes the clinical trials, it submits a new drug application (NDA) to FDA’s Center for Drug Evaluation and Research (CDER). The NDA contains not only the clinical trial results, but also information about the manufacturing process and facilities, including quality control and assurance procedures.

FDA has 180 days to review an NDA. If it finds deficiencies, such as missing information, the clock stops until the manufacturer submits the additional information. If the manufacturer cannot respond to FDA’s request (e.g., if a required study has not been done, making it impossible to evaluate safety or effectiveness of the drug), the manufacturer may voluntarily withdraw the application. If and when the manufacturer is able to provide the information, the clock resumes and FDA continues the review.

The Prescription Drug User Fee Act (PDUFA) was passed in 1992, and mandated that drug companies pay user fees so the FDA could add more resources and speed up drug review times, without compromising standards.In 1997, the PDUFA was renewed under the Food and Drug Administration Modernization Act and then renewed again in 2002 for five more years.

Nowadays it is 180 days of marketing rights only.

Your Answer: c. New drug approvals were for a five year period and had to be renewed every five years to remain on the market