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Executive Briefing Series (formerly The Food & Drug Letter)
Oct. 19, 2012
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In a report released in September to President Barack Obama, his Council of Advisors on Science and Technology (PCAST) set out the history, current environment and future challenges that led it to present several proposals on propelling innovation in drug discovery. Many of these already are in progress, part of the 2010 Affordable Care Act and this year’s FDA Safety and Innovation Act and other initiatives, including those in the private industry and academia. But others remain in the realm of ideas. The past quarter-century has seen tremendous progress in biomedical research, leading to an increasing understanding of cancer, heart disease, diabetes, and other devastating diseases. The U.S. has led the world in such progress, due in significant part to wise investments by the federal government in basic biomedical research. These breakthroughs are beginning to pay off in new therapies for American patients. Still, the pace of new therapeutic development has not kept up with the explosion in scientific knowledge. The report notes that the number of novel drugs has remained constant for several decades, even as R&D budgets have substantially increased. To identify and develop constructive solutions to this challenge, PCAST engaged a wide range of stakeholders in developing the report. This issue of The Food & Drug Letter presents an edited version.
Biomedical innovations — including advances in medicines, medical procedures, and public health — have provided extraordinary benefits to the U.S. public.
Despite advances in U.S. medicine, pressing needs remain for innovative medicines and cause for concern about the pace of innovative drug development, according to a new study.
Key challenges affect the ecosystem for innovative medicines.
In addition to the issues facing drug discovery and development, critical challenges related to drug evaluation must be addressed to advance innovation to serve public health needs.
The President’s Council of Advisors on Science and Technology’s (PCAST’s) high-level goal is ambitious.
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