anies, while other drug companies sometimes pick up the tab of large political receptions. According to public filings, drug companies and organizations spent more that $41 million to influence congress in 1996 (Lewis 147). In November 1997, the FDA Modernization Act of 1997 was passed in cooperation with Vice President Al Gore's Reinventing Government Program. The act, which focuses on reforming the regulation of food and medical products, provided for a number of different modifications, including the reauthorization of the Prescription Drug User Fee Act of 1992 (mentioned above), which helped to reduce the average 30 month process of drug review (Lewis 151). The Modernization Act also introduced advancements designed to accelerate the certification, approval and regulation of drugs. In addition to accelerating the review of important new medications, the act describes the FDA's wishes to increase patient access to experimental drugs and medical devices. Although the FDA claims that they are not lower the standards by which pharmaceutical products are introduced to the market, the Modernization Act allows for one clinical investigation to serve as the basis for approval in certain situations. However, the general rule remains that two adequate and well-controlled studies are needed to prove the product's safety and effectiveness (FDA Modernization Act of 1997 2). Many people protest that the Modernization Act significantly affects the ability of the FDA to safeguard drugs, especially concerning the continued acceptance of 'off-label' uses for drugs.Off-label use allows approved drugs to be prescribed for unapproved uses, which can include the combination of drugs. Off-label uses for drugs haven't acquired enough substantial evidence to deem them worthy of approval. However, the FDA has no authority over physicians, who can legally prescribe any approved drug for any use they see fit. The only regulation of off-label us...
