Physicians Amendment

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. 

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. 

Durham-Humphrey Act(1952) - This amendment defined specific drugs which may be supplied by a licensed pharmacist upon the prescription by a registered physician. Under this act these drug prescriptions may not be refilled unless authorized by the physician. 

The strength of the temperance movement in overcoming economic realities of the day is illustrated by the effect the Eightieth Amendment had on the collection of fees by the Internal Revenue Service (IRS). In 1916, gross receipts at the IRS were 513 million, of which 241 million were derived from distilled spirits and fermented liquors. Thus, 47 percent of IRS receipts were from alcohol-related income versus 13 percent from personal income tax. The movement s fervor also affected the medical profession. With the cynical belief that physicians would discharge their responsibilities under prohibition no better than they had under the Harrison Act, new legislation was created. The specific law, the Willis-Campbell Act of 1921, was enacted in order to restrict the number of liquor prescriptions permitted by each physician. 

Although negligence represents the most important legal complication of clinical practice, the exposure of optometrists to malpractice claims remains at a relatively low level, for below that of physicians. Within optometry there is no difference between diagnostic and therapeutic drug use with regard to the risk of malpractice, because professional liability insurance premium costs do not vary on this basis. However, as optometry laws continue to be amended to enable optometrists to serve as primary providers of eye care, this increased clinical responsibility inevitably wiU result in increased litigation. 

The Law dated 31 May 1961 regulated the supervision of pharmacies and pharmaceutical establishments. The Order dated 20 September 1974 defined the statutes of inspectors, physicians, pharmacists, dentists and veterinary surgeons. Two Orders dated 26 September 1980 and 1 September 1981 were enacted to amend and update the statute of public health inspectors. The last Order dated 30 September 1996 amended the recruitment conditions of public health inspectors. 

FDA published the Black Book containing industry guidance entitled Procedures for Appraisal of the Toxicity of Chemicals in Food. 1951 Durham-Humphrey Amendment defined the types of drugs that could only be used with medical supervision and restricted their sale by prescription of a licensed physician. 

When gender differences in safety or efficacy were found to be clinically significant, most respondent companies (94%) opted to put the data in the product label, the Physicians Desk Reference and the product literature (72%), and to publish in the medical journals (69%). Presumably, the two companies that did not amend their labels acted thus because the products were only intended for one-gender use. By December 1999, there were 348 medicines in development for diseases only in women or where women are disproportionately affected (Holden, 2000). Not only has industry stepped up its research efforts, but many large firms have units devoted to women s healthcare. 

The legal basis for an IND was set up in the 1962 amendments. It is unlawful to transport an unapproved drug across state lines unless FDA has issued an exemption. The IND is technically an exemption from the requirements of an NDA. Dmgs labeled Not for human use are also exempt from the NDA requirements, before being transported, but carry regulatory restrictions. Note that technically and legally these regulations apply just as much to noncommercial research physicians, for example in universities, as to pharmaceutical companies. 

The FDA has undergone significant changes since the 1962 Kefauver-Harris Amendments to the FDC Act. Before that time, for example, regulatory decisions that required medical evaluation were made by just a handful of physicians. Today there are hundreds of reviewers in the agency, including physicians, pharmacists and PhD scientists. 

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