14). Soon, Congress passed the Marijuana Tax Act, which was signed into law in 1937. Like the Harrison Act, the Marijuana Tax Act placed marijuana into the same category as the cocaine and opium drugs. It was now illegal to import marijuana into the United States (McWilliams, 1991). However, this law was ineffective in curbing marijuana use (Brecher, 1986, p. 14).
By the early 1940s narcotic addiction had significantly reduced in the United States (Harrison, Backenheimer and Inciardi, 1999). However, this was not the result of legislative initiatives. Instead, it was because World War II was cutting off the "supplies of opium from Asia and interrupt the trafficking routes from Europe" (Inciardi, 1992, p. 24).
Several other legislative efforts in the supply reduction department served to establish more severe penalties for violations of drug laws, and tighten controls and restrictions over legally manufactured narcotic drugs (Harrison, Backenheimer and Inciardi, 1999). The Manufacturing Act created a system of licensing manufacturers and quotas for classes of drugs. In 1961, the United States became one of fifty-four nations to participate in the Single Convention on Narcotic Drugs, which aimed to modernize and coordinate global narcotic control.
In the 1970s two more laws were passed to control drug abuse (Harrison, Backenheimer and Inciardi, 1999). The first was the Racketeer-Influenced and Corrupt Organizations law (RICO) and the other was the Continuing Criminal Enterprise (CCE) statute. Both aimed to forfeit ill-gotten gain, the removal of the rights of drug traffickers to any personal assets or property - including real estate, cash, automobiles, and jewelry, -obtained by or used in a criminal enterprise or act.
In the 1980s, four major antidrug bills were passed (Harrison, Backenheimer and Inciardi, 1999). All four were in the supply reduction arena. The first was the Comprehensive Crime Control Act of 1984, which expanded criminal and civil asset forfeiture laws and increased Federal criminal sanctions for drug offenses. The second was the 1986 Anti-Drug Abuse Act, which enabled treatment and "restored mandatory prison sentences for large-scale distribution of marijuana, imposed new sanctions on money laundering," and other demand reduction components (BJS, 1992, p. 86). The third was the 1988 Anti-Drug Abuse Amendment Act, which increased the sanctions for crimes related to drug trafficking and developed new Federal offenses. The fourth was the Crime Control Act of 1990, which focused on supply reduction and law enforcement, increasing the appropriations for drug law enforcement grants to states and localities, and strengthening forfeiture and seizure statutes (BJS, 1992, p. 86).
The first pressures for drug policies in the United States started after the Civil War, which had spurred the separation of drug manufacturers from drug prescribers and drug dispensers (Mayo, 2000). Because traveling medicine salespeople were selling dangerous, addictive, and phony patent medicines, there was a definite need for legislation. Many of today's pharmaceutical companies began with the shady shops of that time, but still, most drugs were imported from Europe. At the time, the America was a dumping ground for substandard and contaminated drugs from Europe.
Harvey Wiley of the U.S. Department of Agriculture started testing food products for adulteration in the 1870s (Mayo, 2000). He became chief chemist of the Department of Agriculture in 1883. In 1890, Congress passed a law to stop importation of dangerously adulterated food or drink. The President had the power to order a proclamation prohibiting such products from entering the country.
In 1906, Harvey Wiley wrote the Pure Food and Drug Act, praising President Teddy Roosevelt (Mayo, 2000). The act was aimed to stop shady practices in the food and drug industries described in Upton Sinclair's book, the Jungle. One of the worst references in this book is to the lard industry, where if workers fell into a lard vat..." sometimes they would be overlooked for days, until all but the bones of them had gone out to the world as Durham's Pure Leaf Lard." Clearly, there was a need for legislation.
The 1906 Pure Food and Drug Act developed harsh penalties for certain acts of misbranding and adulteration (Mayo, 2000). The act required the identification of narcotics. It developed quality standards based on monographs published in the U.S. Pharmacopoeia, and took many dangerous products off the market. Unfortunately, the U.S. Supreme Court weakened the act in a ruling saying it did not prevent false health claims, only false labeling. The 1912 Shirley Amendment tried to correct this loophole, but left another. It required a prosecutor to prove a deliberate intent to defraud the public.
The Shirley Amendment failed to control the marketing of new drugs, devices and cosmetics (Mayo, 2000). However, it was firmly in place for thirty-two years until the drug industry once again faced consumer advocates that demanded resolution of the industry's unethical practices. Two writers, Kallet and Schlik, wrote a book called 100,000 Guinea Pigs, and founded Consumers Research. Ruth Lamb wrote American Chamber of Horrors, which caught the public's attention. Lamb had been secretly hired by the Department of Agriculture to write a book that would stimulate the passage of legislation. These books drew attention to examples of poisonous cosmetics, contaminated foods, and false drug advertising.
Unfortunately, it was ultimately a national tragedy that resulted in new drug policies. In 1937, the Massengil Company marketed a new product, sulfanilamide elixir, which is an antibiotic that is insoluble in water (Mayo, 2000). Massengil chemists dissolved the drug in ethylene glycol instead. No toxicity testing of the product, containing what we now call automotive antifreeze, was conducted and little was generally known about its toxicity. Over a hundred people were killed before the government pulled the product from the market. Still, the only power the government had to do so was in a technical labeling violation: the drug product was a solution, not an elixir (e.g., it did not contain alcohol).
The resulting Food Drug and Cosmetic Act of 1938 required that proof, in the form of a New Drug Application was required to be submitted to a new department called the U.S. Food and Drug Administration (Mayo, 2000). Those marketing new drugs had to show safety for intended use in the form of an NDA.
Congressional hearings in the 1950's and 1960's raised the public's interest regarding excessive drug costs, poor competition, price controls and patent protection (Mayo, 2000). In this period of major industry growth and the rapid introduction of key drugs (including penicillin, the sulfonamide antibiotics and tetracycline, the first antihistamines, cortisone, and tranquilizers), the FDA and many clinical investigators were harshly criticized for inefficiency and dishonesty. However, again, it would take a national tragedy to bring about new policies.
Thalidomide was discovered in West Germany and sold over-the-counter as a tranquilizer until 1961, when it was recognized as causing a type of polyneuritis in adults (Mayo, 2000). The drug become associated with an outbreak of phocomelia, which is also known as "seal limbs." By that time, over a thousand "flipper babies" were born with disfigured appendages. The drug was distributed worldwide, except in the United States. The Merrell Company had been conducting U.S.. experiments since 1960 but had not gained marketing approval. An FDA Medical Officer had insisted on further proof of safety before granting marketing approval to Merrell. In so doing, the FDA limited the number of phocomelia babies in the U.S. To only a few cases.
The 1962 Kefauver-Harris Amendments (to the 1938 Food Drug and Cosmetic Act) forced pharmaceutical companies to provide evidence of safety and efficacy (Mayo, 2000). Numerous acts have been passed since 1962, but the Kefauver-Harris amendments, and the FDA regulations promulgated from them, mainly govern drug research and development to this day.
The 1962 amendments had a major impact on drug development (Mayo, 2000). On a positive note, the act required that the FDA be informed before a company begins human testing, thus eliminating the old method of starting clinical trials on the basis of animal toxicity tests. This policy enabled the FDA to license and inspect drug manufacturers. It also prevented the use of generic names that were vague and hard to remember, a practice the manufacturers used to reduce generic substitution. However, it could be argued that this legislation has increased the time it takes for a new drug to reach the marketplace, has substantially increased research expenses and retail cost, and has limited the breadth of drugs as companies target their research and development investment only at the most promising and potentially profitable, candidates.
After the 1960s, the U.S. focused mainly on harm reduction policies, According to DuPont and Voth (2000): "In theory, harm reduction is a public health philosophy that seeks to lessen the harms caused by both drug abuse and drug policies. In practice, harm reduction means promoting and implementing pragmatic measures that help save the lives of people who use drugs and that reduce the pain of suffering people."
According to Drucker (1999): "Current harm reduction practice is a response to two…