Drug Amendments

Kefauver-Harris Drug Amendments are passed. These require drug manufacturers to prove... 

A. Federal Food, Drug, and Cosmetic Act of 1938 and the Kefauver-Harris Drug Amendment of 1962... 

Animal Drug Amendments, 18 685 Animal fats, 5 27, 28 Animal feed binders... 

Passage of the first Orphan Drug Amendment to encourage development of drugs for small markets. 

The 1962 Drug Amendment made three major changes in the manner in which new drugs could be approved (Merrill, 1994). First, and perhaps the most important, was that it introduced the concept of effectiveness into the approval process. An NDA had to contain evidence that the drug was not only safe, but also effective. The 1938 law contained no such specification. The effectiveness requirement necessitated that a drug company had to do more extensive clinical trials. The new law required that companies apply to the FDA for approval of its clinical testing plan... 

The Pure Food and Drug Act established the Food and Drug Administration (FDA), which now oversees the manufacture and use of all foods, food additives, and drugs amendments (1938, 1958, and 1962) strengthened the law considerably. 

Following enactment of the Drug Amendments of 1962, FDA immediately encountered... 

Now is an opportune time to make these observations. Both the pharma industry and the agency are under special stresses, which are having negative effects on the discovery and testing of new drugs and on their availability to physicians and patients. To start, we review the enormous changes since the Drug Amendments were enacted in 1962, in order to understand what may (or should) happen in the future. 

These findings were disputed by Vernon and Gusen (1974), who instead report for the 1965-1970 period that larger firms were better at innovation than smaller firms (p. 294). To be sure, as those authors acknowledge, the latter period followed the introduction of the 1962 Drug Amendments that required demonstrations of efficacy as well as safety for the introduction of a new drug, while my earlier study preceded the new law. A possible... 

Orphan Drug Amendments of 1983 Provided incentives for development of drugs that treat diseases with less than 200,000 patients in USA. 

The Durham-Humphrey amendment, known as the prescription drug amendment, sets standards to distinguish prescription drugs that require supervision by a licensed health practitioner from less risky and harmful over-the-counter (OTC) drugs. 

Hubert Humphrey, Democratic senator from Minnesota from 1949 to 1964, and again from 1971 to 1978, and vice president of the United States from 1965 to 1969. A pharmacist before going into politics, Humphrey cosponsored the 1951 Prescription Drug Amendment that defined the distinction between prescription drugs that required supervision by a physician and OTC drugs. The law remains a key to the system of prescription drugs today. 

---