and JavaScript. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible. Wood, PhD President & Chief Executive Officer ... Technology (now Hologic), where she championed the development, regulatory approval and commercial release of the first FDA approved (PMA) software product for the automatic detection of lung nodules in both diagnostic and screening chest CT examinations. “Nobody was more surprised than me by von Eschenbach's path to approval for 18 and over,” says Wood. Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily. The act collects fees from industry for reviewing drug applications and is up for reauthorization.

", - see this story from The Washington Post. BTW, Susan Wood is the #2 choice of respondents to my Who Should Obama Nominate for FDA Commissioner? Indeed, Wood's departure was “one little story,” she says, “but it tied in with bigger issues.”, To some observers, Plan B had come to represent the rudderless FDA, as well as the 'ideology trumps science' policy of the socially conservative White House, which feared that an over-the-counter (OTC) contraceptive, designed to prevent pregnancy if taken within 72 hours after unprotected sex, would encourage promiscuity in young, unmarried women. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. Like everyone else, I have a lack of real information about what was going on in the FDA at the time.”. So, why wait? ISSN 1546-1696 (online). “The FDA was without leadership for most of the time that Bush has been in office,” says Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development in Boston. You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.
In 2003, an FDA advisory panel voted to give Plan B OTC status, and the drug had been available by prescription since 1999, distributed by Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, of Pomona, New York. Nature Biotechnology View Susan F. Wood’s profile on LinkedIn, the world's largest professional community. Although Wood comes from an academic background—studying basic biology at Johns Hopkins University in Baltimore and biochemical transduction pathways at the Marine Biological Laboratory at Woods Hole, Massachusetts—she also is steeped in policy. as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in She is also the Director of the Jacobs Institute of Women's Health. Still, there was talk of a $1.2 million budget reduction to the FDA's Office of Women's Health, a significant chunk of an overall $4 million budget, which was “viewed by people in the FDA as payback for an office that was very vocal on Plan B,” says Ira Loss, senior health policy analyst at the investment research firm Washington Analysis in DC. There's “an imperative that researchers engage in discussion.”, You can also search for this author in The FDA became a pawn in an ideological chasm.”, People should not just lock themselves up in their labs and assume all will go well. 300 N. Washington St., Suite 200, Falls Church, VA 22046, USA, Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578, Copyright © 2020. There's an imperative that researchers engage in discussion. Get the most important science stories of the day, free in your inbox. It wouldn't have been possible to stay silent in the agency, and I couldn't, as part of the agency, [publicly] say they made the wrong decision.”. When this FDA official resigned over foot-dragging on Plan B, she was placed at the center of a maelstrom concerning political interference in agency decision-making. But the policy issues she confronted over Plan B went beyond rational argument, she says. 3 Speen Street, Suite 300, Framingham, MA 01701. Internet Explorer).

She hit the speaker circuit, telling scientific, legal, policy and women's groups about her experience, and warning that it wasn't just about Plan B, but also about the overall integrity of the FDA. PLUS: in every issue, you get links to additional documents that support DID’s articles, such The profit margins and management of Community Health Group raise questions about oversight of managed care insurers. September 27, 2006 Speaker: Susan F. Wood, Ph.D., Former Assistant Commissioner for Women's Health and Director of the Food and Drug Administration Office … Barr submitted a revised application, asking for approval for women 16 and older, but even that filing languished. Financial experts are warning practices about the pitfalls of promoting medical credit cards to their patients. “The FDA deals with safety and efficacy, not issues of promiscuity.” Furthermore, “there was no transparency in how the FDA made the Plan B decision.

Former Assistant Commissioner for Women's Health at the FDA.

But the FDA's top brass and its commissioner at the time, Lester Crawford, blocked approval anyway, telling Barr in 2004 that the agency was concerned about adolescent use. “So it was much more susceptible to political whims.

A confirmed commissioner helps increase transparency at the FDA, says Kaitin, and should decrease the influence of politics at the agency. “The rationale for [the original] rejection had no bearing on the medical issues of the product,” says Kaitin.

Susan Wood did not think quitting the FDA in August 2005 over the agency's handling of the Plan B birth control product would garner much notice. No one is suggesting all those changes are due to Wood quitting, but she serves as a reminder about social responsibility. Become a subscriber to Drug Industry Daily today. So she quit, writing in correspondence to colleagues she could “no longer serve as staff” when scientific and clinical evidence has been overruled. Subscribe to FierceHealthcare to get industry news and updates delivered to your inbox.

Who's the #1 choice? Susan F Wood is Professor of Health Policy and of Environmental and Occupational Health. PubMed Google Scholar, Pessimistic response to FDA leadership change, Many issues in store for new FDA commissioner, Women's health advocates dismayed at FDA's Plan B decision, Tufts Center for the Study of Drug Development, Wilan, K. Profile: Susan Wood. proposed legislation, and many others.

Register for the Fierce Health IT Virtual Series: Telehealth's Takeover, Join us Nov 9-11 for a look at how telehealth has transformed healthcare delivery and what it will look like in the future, Susan Wood, assistant commissioner for women's health at the FDA, resigned to protest the agency's handling of Plan B, claiming that it was politically motivated.

In the meantime, to ensure continued support, we are displaying the site without styles All rights reserved. volume 25, page495(2007)Cite this article. It couldn’t be easier. Sometimes it requires additional thought. Susan F. has 7 jobs listed on their profile. Design, CMS, Hosting & Web Development :: ePublishing, We use cookies to provide you with a better experience. Guest. Among her messages: “If government agencies are not given the support to do jobs properly, they won't draw people in that can do the jobs.” Wood is now a research professor at the School of Public Health and Health Services at George Washington University in Washington, DC. Susan Wood, George Washington University School of Public Health and Health Services.
Susan A. Rather, Senators Hillary Rodham Clinton and Patty Murray threatened to block von Eschenbach's confirmation as new FDA commissioner unless the Plan B issue was resolved. Use a + to require a term in results and - to Enclose phrases in quotes. Able to talk freely after leaving, Wood found a public eager to listen. The history of Plan B at the FDA suggests as much. Peter Rost , former Pfizer marketing executive, now drug industry whistleblower, author, and blogger! Susan Wood, assistant commissioner for women's health at the FDA, resigned to protest the agency's handling of Plan B, claiming that it was politically motivated. Reproduction in whole or part is prohibited. Susan Wood. Who's the #1 choice?

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exclude terms. The suggested budget cut was met with a chorus of criticism and eventually scuttled, and the FDA has suggested a plan for curbing the influence industry has with scientists, but Wood says the FDA will be shaped significantly by what happens with the Prescription Drug User Fee Act (PDUFA). And even though she “is not a sensationalist,” as acknowledged by Vivian Pinn, director of the Office of Research on Women's Health at the National Institutes of Health (NIH), who had worked with Wood on women's health initiatives, her resignation caused a sensation nonetheless.