New Drug Amendment

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... 

A minor precedent for premarket testing of chemicals in the 1938 law had been established, on a voluntary basis, shortly after the 1906 law had gone into effect, with respect to coal-tar dyes used to color foods (98). The new drugs clause of 1938, in its turn, became a more significant precedent for later laws requiring the establishment of safety before the release of pesticide chemicals (1954), food additives (1958), color additives (1960), and medical devices (1976) (99, 100). In 1962, by the Kefauver-Harris Amendments, the Congress added the requirement that proof of efficacy be demonstrated before a new drug could be released. 

Flollister LE, Page IFI, Pfeiffer CC, Visscher MB. (1968). The Kefauver-Flarris amendments of 1962 a critical appraisal of the first five years. J Clin Pharmacol J New Drugs. 8(2) 69-73. 

In 1962, amendments to the Federal Food, Dmg, and Cosmetic Act added a proof-of-efficacy requirement to new drug approvals before that time, the FDA approved drugs for safety only. As a result of the amendments, brand-name companies are required to prove that new drugs are safe and effective prior to FDA approvd. To prove safety and efficacy, brand-name companies are required to conduct tests on humans ( clinical trials ) and to submit those results to the FDA with their new drug application (NDA). 

Under the FD C Act as enacted in 1938, adulterated and misbranded drugs may lawfully be exported but an unapproved new drug could not. This was a drafting error, but it was nonetheless enforced by FDA. Congress therefore enacted the Drug Export Amendments Act of 1986, which authorised the limited export of unapproved new human drugs and biological products after FDA had approved an export application. An export application could be approved only if... 

Amends the Pubhc Health Service Act to eliminate the requirement of separate product and establishment licences and directs FDA to harmonise the review and approval requirements for biological products and new drugs to the extent possible. 

Second, FDA had to confront the fact that prior to the 1962 Amendments it had issued hundreds of old drug opinion letters for generic versions of pioneer new drugs. It, therefore, issued a statement of policy in May 1968 revoking all of those opinions. ... 

The FDA pace of implementation of the 1962 Amendments was, however, necessarily slow. The American Public Health Association therefore brought a lawsuit to require FDA to complete its DESI programme for pre-1962 new drugs. 

Three t)rpes of rmusual IND situations deserve special mention. First, the regulations contain a provision governing emergency use of an investigational new drug. Where FDA will permit such use by telephone or other rapid communication means. In these situations, the IND must subsequently be amended to reflect the new situation. Second, FDA will approve specific... 

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