WHEN IS THE BEST CHANCE A NEW Rx DRUG WILL BE APPROVED FOR MARKETING?
“Based on the recently-released government statistics, 113 New Drug Applications (NDAs) for prescription drugs were approved during the presidential election year 2004,” according to Jack Shapiro, an internationally-known healthcare marketing consultant and market researcher, futurist, broadcast journalist and public speaker.
“Last year’s NDA approvals were 57% higher than the 72 NDAs approved in 2003, one of the slowest years for NDA approvals in the past decade. Is medical progress being made a victim of political opportunism? Are vital new drugs being held back in order to score political points during election years?
“But don’t just blame the Bush Administration. This is another sign of a well-documented bipartisan trend,” Shapiro notes. “Since 1990 (the first year for which data are available), regardless of which party held the White House, New Drug Applications have had a better chance of approval during an presidential election year than at any other time.”
Here are the statistics:
• In a typical year, 86 NDAs were approved since 1990;
• During presidential election years (‘92, ‘96, ‘00, and ’04), an annual average of 108 NDAs were approved;
• In non-presidential election years, an annual average of only 77 NDAs were approved (about 30% lower compared to a presidential election year).
A New Drug Application (NDA) occurs after intensive pre-clinical screening and three vigorous phases of clinical trials that could easily require a decade of development time and almost $1 billion. All-in-all very few potential new drugs ever make it to the NDA submission point. In the past 15 years, about 75% of New Drug Applications have ultimately been approved following an intense review process by the Food and Drug Administration that has been known to sometimes take years
What tends to happen to NDA approval trends immediately before and after presidential election years? For further information about this trend, its underlying factors, and potential consequences, please contact Jack at:
JACK M. SHAPIRO
P.O. BOX 1025
Maywood, NJ 07607
Phone: (201) 441-9815
e-mail: JSHEALTH@AOL.COM
Website: www.JackShapiro.com
THIS MAN KNOWS ABOUT THE FUTURE OF HEALTHCARE
Jack M. Shapiro, is an internationally-known healthcare marketing consultant, futurist, broadcast journalist and public speaker announces the availability of his free on-line video discussing the future of healthcare (www.JackShapiro.com).
Jack includes among his clients major pharmaceutical and insurance companies, advertising agencies, hospitals and manufacturers of medical equipment supplies and devices. Often quoted in the healthcare industry, general business, and lay publications, Jack has been a frequent guest on national television (ABC, NBC, MSNBC, CNBC, FOX, PBS and abroad on BBC and ITN) and radio as a commentator on healthcare trends and politics in the United States and overseas.
From 1997-1999, he was the host of “MEDI-POLITICS,” a nationally-syndicated radio show focusing on the politics and future of healthcare as well as key legal and ethical issues. The show reached more than 40 markets in 26 states and an audience of 31 million people.
Jack has spent more than 35 years in the healthcare field, both in the U.S. and abroad. Before forming his successful research and consulting company, he held high-level management positions in marketing and market research with healthcare giants such as Wyeth and Pfizer.
He is currently writing a book about the future of American healthcare based on his long experience in the healthcare industry, in-depth interviews with leading experts who appeared on his radio show as well as on-going poll results generated by his market research company.
Recently Jack was the event host of the “Global Pharma R&D Summit” in Scottsdale, Arizona (September 13 – 15, 2004), attended by over 250 top pharmaceutical scientists from around the world.
Jack is a member of the American College of Healthcare Executives.
ARRANGE A KEYNOTE SPEECH, ARTICLE/COLUMN OR INTERVIEW WITH JACK SHAPIRO ON THESE TOPICS:
. What’s the future of American healthcare?
. What are the latest clinical trial trends?
. Who are the uninsured and the underinsured?
. What’s driving up the cost of healthcare?
. What can people do to save on healthcare costs?
. Healthcare in Bush’s second term agenda and implications for 2006 and 2008 elections
. Why is ours the “Healthcare Economy?”
. What’s the future for employer provided healthcare?
. Tomorrow’s breakthroughs in biotechnology and surgery: will we be able to afford them?
. Why are so many people turning to “alternative” healthcare?
See Other Press Releases from Jack Shapiro On His Website at www.jackshapiro.com
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