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Halcion user blaming the FDA for approving a dangerous drug [30]. As of January 1994, there were 49 suits pending nationwide. Of the 135 suits since 1983, 86 were dismissed or settled [31]. |
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Finally, liability has been shifted to pharmaceutical manufacturers by the manufacturers themselves. In an effort to increase market share, several companies have offered indemnity for prescribers of their recently approved products (e.g., Norplant). In June 1994, about 1000 Norplant users joined a nationwide class action suit alleging that the manufacturer did not adequately warn them of the lengthy surgery and scarring that may occur when the implant is removed [32]. Other manufacturers guarantee their products in exchange for placement on managed care formularies. |
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C. Effects on the New Drug Development Process |
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What effects do the above issues have on new drug development? They increase the costs of research and development (R & D), require more studies to be done to show safety, channel R & D into areas with less risk, and force companies to move overseas. |
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Companies avoid pursuit of high risk products that may put them out of business. Product areas where manufacturers have been discouraged from investing in R & D because of enormous legal liability include contraceptive products, vaccines, and pediatric products. In other cases, venture capitalists are reluctant to invest in products when the risk of litigation is high. This liability climate tends to force some companies to move overseas. Liability is a substantial reason that companies are going overseas with their products. Other reasons include U.S. export restrictions and the U.S. regulatory system. There has been a visible shift of some preclinical R & D and manufacturing overseas to Europe or Japan [3335]. United States companies have stringent data requirements for INDs. The data requirements are prompting more and more researchers to conduct clinical trials overseas. Europe has a much easier process for registering clinical trials [36]. Although the total number of commercial INDs filed with FDA has held at around 300400 per year over the past decade, PhRMA data reveal that only about 20% of Phase I studies now are conducted in the United States, compared with about 50% 10 years ago [37]. A recent survey conducted by the Gallop Organization examined 58 U.S. medical electronics manufacturing companies. Forty percent said they had cut their workforce in the United States as a consequence of regulatory delays, and 22% said they had already moved U.S. jobs overseas [3]. For the first time, the American College of Cardiology has received more abstracts from outside the United States than from inside for its 1995 meeting [38]. The trend in the United States is toward allowing more and more foreign data and there have been instances where entire NDAs were based on foreign data. It is natural |
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