The FDA's authority to make such decisions of whether or not new medicines (prescription drugs) should be allowed to go on sale in the United States dates back to the passage of the Food and Drug Safety Act of 1906. This law required that all medicine be correctly labeled as to their contents and that the medicine not contain any substances harmful to consumers health. These laws are sometimes prompted after there has been a tremendous life or death effect. For example, In 1938 the Food and Drug and Cosmetic Act forced manufacturers to demonstrate the safety of new drugs before being allowed to offer them for sale. This law was prompted because 107 people had taken Elixir Sulfanilamide, an antibiotic that had been mixed with poisonous diethylene glycol a chemical of antifreeze.
Lives are saved because unsafe or ineffective drugs are kept off the market, but the regulatory process by the FDA delays or even prevents the introduction of some sage and efficacious drugs, thereby costing lives. Debate continues over how much FDA regulation is needed to ensure that drugs are both safe and efficacious. It does take time to ensure that patients benefit from, rather than are harmed by, new drugs, but regulation induced drug lag can itself be life threatening. Subsequent revisions to the FDA process for reviewing drugs have been in response to the deaths and other adverse health effects by the regulation induced drug lag. The eventual FDA decision to speed up the review process was prompted by intense lobbying by individuals who believed that they might benefit from drugs not yet approved. As stated in our reading passage, it is incorrect to ascribe the generally safe and effective nature of modern drugs entirely to FDA protection. Even with FDA oversight, the drug development process is inherently long, complicated, and costly. Some people would die waiting for new drugs because self interested manufacturers would insist on some testing, and cautious physicians would proceed slowly in prescribing new drugs.