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The U.S. Food and Drug Administration (FDA) shoulders the enormous responsibility of ensuring the safety, efficacy and quality of prescription and non-prescription human medicines and vaccines. In addition, it regulates medical devices and diagnostics, veterinary medicines, cosmetics, blood and blood-derived products and, most recently, tobacco. According to a 2007 report from the U.S. House of Representatives’s Subcommittee on Science and Technology, “FDA Science and Mission at Risk,” products and services regulated by the FDA comprise one quarter of every consumer dollar expended in this country annually. The evolution of the FDA’s regulatory authority is linked to a series of seminal public health events over the past 100 years. In response to unsanitary conditions in the meat-packing industry and the sale of worthless and dangerous patent medicines, Congress passed the Pure Food and Drugs Act in 1906, which prohibited interstate commerce in misbranded or adulterated foods and drugs and served as the basis of future FDA regulatory authority. Then, the Federal Food, Drug, and Cosmetic Act (FD&C Act), which formally established the FDA, was passed in 1938 in response to the death of many children from elixir of sulfanilamide containing the poison diethylene glycol (antifreeze). The FD&C Act was amended in 1962 after thalidomide was approved in Europe as a sleeping aid and found to cause significant birth defects. Although not approved in the U.S., the thalidomide experience led to the requirements that U.S. drug manufacturers provide substantial evidence of efficacy and safety before marketing.
Not surprisingly, the FDA subsequently entered a period of increasing conservatism, which triggered a “drug lag,” during which many new drugs were approved elsewhere but not in the U.S. Ultimately, this lag prompted public concerns about lack of access to innovative new medicines and spawned the Prescription Drug User Fee Act (PDUFA) in 1992 and its subsequent three reauthorizations. In order to provide the FDA with adequate resources, PDUFA established user fees to be paid by drug manufacturers when submitting a new drug application. In return, industry could expect increased regulatory predictability through the establishment of FDA performance goals for review timelines and industry access to FDA advice. By 2000, the majority of new drugs were being first approved in the U.S. or simultaneously in Europe and the U.S.
The process of developing therapeutics has multiple expense points, which will undoubtedly change as new business models replace old ones. Here is a snapshot of the current major expenditures related to the bench-to-bedside enterprise.
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