GAO Identifies Factors Hampering Development of New Drug Applications

by Sabrina I. Pacifici on December 19, 2006

New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts, Full text GAO-07-49, and Highlights, November 17, 2006.

  • “Recent scientific advances have raised expectations that an increasing number of new and innovative drugs would soon be developed to more effectively prevent, treat, and cure serious illnesses. However, industry analysts and the FDA have reported that new drug development, and in particular, development of new molecular entities (NMEs)–potentially innovative drugs containing ingredients that have never been marketed in the United States–has become stagnant.”
  • Press release: “GAO Analysis Refutes Industry Myths About Drug Development – Rep. Waxman, along with Sens. Durbin and Kennedy, today released a new GAO analysis revealing a decline in new drug development by the pharmaceutical industry. The report contradicts the myth that higher research expenditures have resulted in more treatment options for patients…The panel of experts convened by GAO recommended increased collaboration among government, industry, and academia in the drug development proces and in the development of scientists who can translate scientific breakthroughs into practical results. The panel also indicated that the government could consider providing additional financial incentives — such as longer patent lives for innovative drugs and shorter patent terms for “me-too” drugs — to shape the drug development process.”
  • Fact Sheet on Drug Development, by Rep. Henry Waxman
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