Investigation showed, however, that directions for use provided on labels varied considerably from manufacturer to manufacturer; that most products did not carry detailed instructions nor warnings about hazards. After reviewing available evidence, FDA concluded that reported adverse reactions were not sufficiently great to justify removal of the sprays from the market, but that warnings to consumers were needed. As a result, FDA proposed that labels for all feminine. deodorant sprays carry complete instructions for use and a warning which must be displayed prominently on the container. The warning statement which FDA proposed reads: CAUTION: For external use only. Spray at least 8 inches from skin. Use sparingly and not more than once daily to avoid irritation. Do not use this product with a sanitary napkin. Do not apply to broken, irritated, or itching skin. Persistent or unusual odor may indicate the presence of a condition for which a physician should be consulted. If a rash, irritation, unusual vaginal discharge, or discomfort develops, discontinue use immediately and consult physician. More accurate information for consumers is also being provided by restrictions on terminology connected with the deodorant sprays. Often the sprays are labeled and referred to as "hygienic," but since FDA has no evidence that they serve any medicinal or hygienic function, the Agency is banning the use of such words as "hygienic" or "hygiene" in the advertising and promotion of these products. Such words, or any others which imply that the sprays have a medical usefulness, are considered misleading and unlawful. It is expected that the Federal Trade Commission will cooperate fully with FDA in regulating advertising which falls in its jurisdiction. The FTC will make a special effort to police the promotion of the feminine sprays on television and in print. Amid the FDA claims that feminine deodorant sprays have no hygienic usefulness-and counter claims by the spray makers that these are "valuable toilet articles"what should the consumer do? No doubt thousands of women will continue to use these products as part of their daily beauty-and-cosmetic 1 Toward A New Era In by Wallace F. Janssen June 18, 1973, must now be added to the list of historic dates in food and drug law history. On that day the Supreme Court of the United States went further than ever before to construe the law in favor of its basic purpose to protect the consumer. Decisions establishing the principle that food and drug laws should not be interpreted narrowly, but broadly to accomplish their purpose, date back more than half a century. But none has expanded regulatory powers and opened the doors of change like the June opinions in five "drug effectiveness" cases. The decisions were voted unanimously by a seven-judge Court, with two of the nine Justices not participating. This article deals with what the Court said about drug effectiveness and then with the broad implications of the opinions. The Long Fight for Effective Drugs How did the Supreme Court happen to rule as it did? Effectiveness of drugs has been sought through medical experimentation and legal sanctions since ancient times. Nothing could be more important to patients, pharmacists, and physicians. The Federal Food and Drugs Act of 1906 prohibited adulteration and misbranding, and hundreds of worthless and dangerous "patent medicines" were taken off the market. Many others had their formulas changed, or dropped label claims of effectiveness which could not be sustained in court. Only five years later (1911), a serious setback occurred. A divided Supreme Court, in a decision by Justice Oliver Wendell Holmes, held that the 1906 law did not prohibit false therapeutic claims, but only false label statements on the identity or composition of drugs. Thus, the promoter of "Dr. Johnson's Mild Combination Treatment for Cancer" could not be prosecuted for "mistaken praise," although the indictment charged that he knew his claims were false. The dissenters, led by Justice Charles Evans Hughes, protested that the decision opened the way for the sale of fake cures for all manner of diseases. And so it did. President Taft at once called on Congress to close this gap. He said: "There are none so credulous as sufferers from disease. The need is urgent for legislation which will prevent the raising of hopes of speedy cures of serious ailments by misstatement of facts as to worthless mixtures on which the sick will rely while their disease progresses unchecked." (continued) A dozen bills were introduced to close the gap and correct other deficiencies in the 1906 law. Congress passed the Sherley Amendment, supported by the drug manufacturers. It prohibited false and fraudulent claims of therapeutic effectiveness. The courts held it constitutional, but the two italicized words had the unfortunate effect of restricting enforcement for many years to cases in which fraud could be proved. This was difficult or impossible in most cases. Thus, the more ignorant the promoter of a worthless preparation the greater his chances were of escaping conviction. 1938-"Safety," but Not "Effectiveness" In 1938, after an untested and poisonous "Elixir" had killed more than 100 people, Congress passed the longpending Federal Food, Drug, and Cosmetic Act. This new and strong law eliminated the requirement that intent to deceive be proved in drug misbranding cases. Labels were required to bear "adequate directions for use" which FDA defined as "safe and effective use." But the Government still had the difficult and timeconsuming burden of proving in court, case-by-case, that drugs were ineffective, to remove them from the market. In the meantime, millions of consumers could be cheated, if not critically injured, through reliance on ineffective remedies for serious diseases. Protection against dangerous drugs, on the other hand, was made much stronger by the 1938 law. Manufacturers were required to provide scientific evidence that new drugs were safe for use before they could be put on the market. The new law came just in time. In an unprecedented era of "miracle drug" development, thousands of new products went on the market with assurance that they were safe-though many were lacking in effectiveness. Thalidomide and the 1962 Amendments Early in the 1960's a Senate committee investigating the pharmaceutical industry heard testimony on the shortcomings of new drug data, as well as shocking instances of "rigged research" to gain FDA approval and promote sales of prescription drugs. Strong new amendments were proposed, but by midsummer in 1962, industry lobbyists had succeeded in watering them down. Again tragedy intervened, when the U.S. public learned of its narrow escape from another drug disaster. Relying on the 1938 law, an FDA medical officer, Dr. Frances Kelsey, had blocked the release of thalidomide on the U.S. market because of unexplained side effects (peripheral neuritis). Then came the discovery in Germany that thousands of deformed infants had been born to mothers who took the supposedly safe sleeping pill during pregnancy. Realizing more clearly than ever that drugs could be unsafe for many reasons Congress voted strong new drug controls Oct. 4, 1962. This was the most fundamental revision of the food and drug laws since 1938. Most important of the many changes was the requirement that the effectiveness of Before 1938 it was not an offense to label a drug with false medical claims. The Government had to prove in court that the claims were false and fraudulent (intended). Each death certificate in this 1936 exhibit was for a person who had given a testimonial on the value of "Banbar" for diabetes, and later died from the disease. When prosecuted, the promoter was acquitted because he believed the product was effective, as shown by the testimonials. "new drugs," as well as their safety, be established by "substantial evidence" before they could be approved for marketing. The law allowed two years for the pharmaceutical industry to obtain the required evidence. But in 1964 when FDA issued regulations calling for scientific data to support efficacy claims, there was immediate opposition in the courts. And although thousands of reports were submitted to FDA by drug firms, they generally did not provide "substantial evidence" of effectiveness as required by the law. 1966-The Drug Effectiveness Study Clearly, another approach was needed if drug effectiveness was to be assured. Thousands of drugs were involved; the job was too much for FDA itself. In 1966 the Agency contracted with the National Academy of Sciences to empanel the top experts of the medical profession for an evaluation of the pre-1962 drugs which had been approved for safety but not effectiveness. More than 200 recognized leaders in drug therapy took part in the project, providing the expert knowledge needed to clear the market of ineffective products and to revise the claims made for others. This across-the-board approach to an industry-wide problem was unique in the history of consumer protection. The Supreme Court in its June 1973 opinions endorsed it as the only practical way to obtain an evaluation of over 16,000 therapeutic claims for more than 4,000 individual drugs. FDA Powers Challenged in the Courts The Drug Effectiveness Study was completed in 1969. The expert panels had submitted 2,824 separate reports. Each required evaluation by FDA and decisions as to labeling changes, or proceedings to halt the marketing of products rated as ineffective-about 7 percent of the total. In general, the medical panelists found that much of the data to support drug claims was poor in quality, and that the claims were improperly stated, promotionally biased, or lacking in proper qualifications. Moving to correct the situation by applying the medical findings, FDA encountered increasing resistance by the drug manufacturers. At the end of 1970, actions to enforce drug effectiveness had been challenged in a dozen lawsuits. The suits attacked FDA's authority to issue regulations and the legality of the regulations already issued. Others contested the applicability of the law to pre-1962 drugs which, they contended, were exempted from the required proof of effectiveness. Court decisions in some of these cases strongly upheld the FDA's actions. In other cases, decisions were rendered in favor of the drug firms, which, if allowed to stand, would have made it impossible for FDA to carry out the drug effectiveness program. These were the cases which the Supreme Court decided June 18, 1973. (continued) |