Barnes Nash (BrowneDahlgaard47)

Not surprisingly, safety problems have been discovered with some drugs long after marketing approval. So while new drugs safety be clarified and their resources have been entering the market more quickly, and expertise strengthened to enable the FDA’s capacity to provide adequate safety effective surveillance and rapid action monitoring and surveillance after the drugs be- when problems are identified. Informing the Future: Critical Issues in Health The IOM committee recommended PDUFA legislation was written so that very little that the FDA’s authority to of this new funding could be used for postmar- successfully monitor postmarket ket drug safety surveillance.

As recent drug safety issues have made evident, the nation’s system for deciding what drugs are approved for marketing—and under what conditions—needs a major overhaul. Be- cause medication errors are the result of multiple points of system failures, effec- tive prevention will require changes on the part of the pharmaceutical industry, doctors, nurses, and pharmacists, as well as the organizations that support them, including hospitals, nursing homes, the FDA, and other government agencies. While only a frac- tion of these errors are significantly harmful to the patient, the report estimated that the costs of treating drug-related injuries in hospitals alone were $3.5 billion a year, not includ- ing lost wages, lost productivity, or additional health care costs.

Medicare outpatients U.S. adults will use prescription experience an estimated 530,000 ADEs each year. In any given week, four out of five U.S. adults will use prescription medicines, over-the-counter drugs, or dietary supplements. Ensuring that the American people get the most benefit from advances in pharmacology is a critical component of improving the national health care system.

While the medical profession was well-established in Europe and America, the pharmaceutical industry was only beginning to develop medicines to treat pain, infectious diseases, heart conditions, and other ailments. In many cases, physicians dispensed medicines directly to patients; companies often supplied physicians with their favorite formulations. Larger companies supported additional legislative interventions, including the 1906 Food & Drugs Act in the U.S. and similar laws in several European countries that prohibited adulteration and forced manufacturers to reveal ingredients on product labels.

While largely unregulated by government bodies prior to the 20th century, the pharmaceutical industry faced challenges in differentiating its products from patent drugmakers whose secret recipes, in fact, were not patented. But U.S. chemists only rarely had the freedom to create new drugs, and relatively few companies manufactured complex therapies. Of the nine company websites, three contain anecdotal information; only two mention electroconvulsive therapy and four mention other types of drug therapy; and only one mentions the tradenames of other drugs.