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Reforming the FDA Dec 2008 Vol. 7, No. 10 • Published by VirSci Corp. www.pharmamarketingnews.com www.virsci.com SurveySurvey ResultsResults Reforming the FDA: It All Starts with a New Commissioner! Author: John Mack PMN710-04 Find resources cited this article online at: http://tinyurl.com/5hgxra This article is part of the December 2008 issue of Pharma Marketing News. For other articles in this issue, see: http://www.news.pharma-mkting.com/PMNissueDec08archive.htm Published by: VirSci Corporation PO Box 760 Newtown, PA 18940 [email protected] Pharma Marketing News Vol. 7, No. 10 p. 2 he Committee on Energy and Commerce in “Pharma Prefers Woodcock As Next FDA Com- the US House and Representatives “has mish” proclaimed Ed Silverman, Newark Star- T found that FDA not only failed in its basic Ledger blogger at Pharmalot on November 7, 2008 mission, but refused to admit its failures and (see http://tinyurl.com/63myt6). Silverman cited an take steps to protect Americans from unsafe food article on Bloomberg.com, which in turn cited un- and drugs," said Rep. John D. Dingell (D-MI), named sources for its conclusion that Woodcock is former chairman of that committee. "In the 111th the top choice of drugmakers who are lobbying for Congress, the committee will swiftly move FDA her to be named the agency's chief (see “Wood- reform legislation that is needed to ensure FDA cock Gains Support From Drugmakers for U.S. does its job." Now that Henry Waxman is the new FDA's Top Job”: http://tinyurl.com/5oh7cu). chairman, "swift" may be inadequate to describe Two months later, Silverman, citing an article in the the changes ahead for the FDA. Wall Street Journal, reported that Joshua Obama In, Eschenbach Out! Sharfstein, now head of the Baltimore Health The biggest and possibly most important change is Department, may be chosen as the next FDA the new FDA Commissioner—current FDA Com- Commissioner (see http://tinyurl.com/642l9l). missioner Andrew von Eschenbach has already Meanwhile, an informal poll of Pharmalot readers announced his intention to resign as of January 20, found that seventy-six percent (76%) are opposed 2009 (see http://tinyurl.com/597nyz). Everyone to the nomination of Steven Nissen, a well-known wants to know who President-elect Obama and his Cleveland Clinic cardiologist and FDA critoc. Secretary of Health and Human Services, Tom Daschle, will choose for that position. Pharna Marketing Blog supported Susan Wood, the former head of women's health at FDA, for the Lately, there’s been some jockeying for the posi- new job. Wood resigned in protest after politics tion both inside and outside FDA. Consider Janet influenced the FDA to override an advisory com- Woodcock, a 22-year FDA insider and currently mittee’s recommendation that the morning-after pill Director of the FDA's Center for Drug Evaluation & be switched to over-the-counter status (see “Susan Research (CDRE), for example. As reported in the Wood: ‘The One to Take the Lead’ of the FDA”: Wall Steet Journal Health Blog (see http://tinyurl.com/5tzojx). http://tinyurl.com/6cyjaf), “as the search for a new FDA Commissioner heats up, Janet Woodcock, an With tongue in cheek, a few extreme outsiders agency insider who’s a possible candidate for the have been suggested. The Wall Street Journal post, would like you to know that she’s not to Health Blog, for example, asked if Comedy Cen- blame…” for the delayed approval of the Plan B tral’s Stephen Colbert should be considered (see morning-after pill for sale over-the-counter amid http://tinyurl.com/5avqt6) and Pharma Marketing “alleged back-room arm-twisting by conservatives Blog’s “FDA Intern” put forth Peter Rost, former close to the Bush White House.” Pfizer VP of Marketing, now an anti-Pfizer whistle blower and blogger, as her choice (see Figure 1, Although Woodcock is reported to be the drug pg. 3). industry’s choice for commissioner, she has powe- rful opponents among democrats in Congress. Rost’s candidacy has since received support from Sen. Bart Stupak (D-MI) made clear his opposition two Congresspeople and at least one blog- in a letter to President-elect Barack Obama (see gerCary Byrd of eDrugSearch.com (see http://tinyurl.com/69m5j2). "Now, in the [Bush] http://tinyurl.com/6acg3g and “Byrd Loves Rost Administration's final days, policymakers at FDA and Scores!”: http://tinyurl.com/6omolu). want to appear to be tough on industry," said Stupak. "This latest posturing is no reason for FDA The Survey political appointees to retain their positions. I en- In order to cut through all the chatter from biased courage the incoming Obama Administration to pundits and journalists and determine the prefer- clean house among FDA’s political appointees and ences of actual stakeholderswhether they be bring change to an agency that badly needs it." executives and staffers working within the pharma- ceutical industry, agents and vendors to the indus- The Pundits Weigh In try, healthcare professionals, members of the gen- Many bloggers and journalists have been busy eral public, or staffers within government health recommending who Obama should nominate as agenciesPharma Marketing News hosted the the new FDA Commissioner to replace Dr. "Who Should Obama Nominate for FDA Commis Eschenbach. The following is a sample of the buzz Continues… out there. © 2008 VirSci Corporation (www.virsci.com). All rights reserved. PMN710-04 Pharma Marketing News Pharma Marketing News Vol. 7, No. 10 p. 3 Figure 1: FDA Intern Recruits Peter Rost © 2008 VirSci Corporation (www.virsci.com). All rights reserved. PMN710-04 Pharma Marketing News Pharma Marketing News Vol. 7, No. 10 p. 4 sioner?" online survey. The survey ran from No- • Public (consumers, consumer advocates, vember 12, 2008 through December 12, 2008. patients, or other non-industry aligned members of the general) Four hundred and seventy-five (475) responses were collected and analyzed. The results are • Pharma (pharmaceutical, biotech, or drug presented below along with comments from device company employees) respondents and selected candidates. • HCP (physicians, nurses, other healthcare professionals or medical students) The Candidates The survey asked respondents to select from a list • Agency (employees of agencies/companies/ of 10 people who were often mentioned as candi- consultancies having pharmaceutical compan- dates in the press and in the Pharma Blogosphere: ies as clients) • Gov't (current or former FDA or other govern- Robert Califf: vice chancellor for clinical • ment health agency employees or staffers) research and professor of medicine in the Division of Cardiology at Duke University • Academia (teachers/professors/non-medical School of Medicine. Califf was considered for students) the job by the Bush administration eight years • Publisher (journalists, bloggers, etc.) ago, but didn't make the final cut. A few respondents (less than 3-5%) who indicated • Dora Hughes: Health Policy Advisor to “other” and described their affiliation (eg, “finan- Senator Barack Obama. She previously cial,” “retired physician,” etc.) were placed into the served as Deputy Director for Health for appropriate category above. The break-down by Senator Edward M. Kennedy on the affiliation is shown in Figure 2, below. Committee on Health, Education, Labor and Pensions in the United States Senate. • David Kessler: former FDA Commissioner under George Bush Snr. and Clinton. • Steve Nissen: cardiologist at Cleveland Clinic. He led the effort that linked COX-2 inhibitors such as Vioxx and Celebrex with heart attacks. • Mary Pendergast: industry consultant who was a former associate FDA Commissioner under David Kessler. • Peter Rost: former Pfizer VP of Marketing, turned drug industry whistle blower, now a blogger and anti-drug industry expert witness for hire. • Joshua Sharfstein: commissioner of the Baltimore City Health Department. Leading the assessment of the troubled FDA for the Obama transition committee. • Mike Taylor: former Deputy FDA Commis- sioner under Clinton. Figure 2: Affiliation of All Respondents (N=475). • Susan Wood: the former head of women's Ninety percent (90%) of respondents were from health at FDA, who resigned in protest after the U.S. Affiliation distribution among U.S. the delay in switching the morning-after pill respondents is virtually identical. over-the-counter. • Janet Woodcock: current Director of the The vast majority (90%) of respondents were from FDA’s Center for Drug Evaluation & Research. the United States. In this analysis, the opinions of these respondents are of most interest because Respondents could also write-in their candidate of the mission of the FDA is to protect the health of choice. US citizens who, therefore, should have the most Profile of Respondents say about who is chosen to head the agency. The survey respondents represented several self- identified stakeholder groups/affiliations: Continues… © 2008 VirSci Corporation (www.virsci.com). All rights reserved. PMN710-04 Pharma Marketing News Pharma Marketing News Vol. 7, No. 10 p. 5 Respondents Support the Pharma Industry As the survey progressed, Rost and Nissen were Fifty-six percent (56%) of all respondents (N=475) virtually tied for 1st place, while Kessler challenged indicated that they were somewhat or very sup- Califf for 5th place. portive of the pharmaceutical industry, whereas Figure 4 shows the final results looking at US only 22% said they were unsupportive (Figure 3). respondents only (N=427). You can view a Survey Results summary results from all respondents online here: To solicit responses to the survey, promotions http://tinyurl.com/5ddk5r were run throughout the Pharma Marketing Peter Rost – A Special Case Network, including email notices sent to Pharma Peter Rost is a special case. He is the only candi- Marketing News subscribers, posts made to date to have publicly solicited votes. Dr. Rost writes for a very popular blog and he actively used this bully pulpit to promote his nomination for FDA Commissioner by encouraging his readers to vote in the survey.
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