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 gerCary 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 stakeholderswhether they be bring change to an agency that badly needs it." executives and staffers working within the pharmaceutical 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 agenciesPharma 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.

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…

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. It is obvious that Rost’s self-promotion has skewed the results in his favor (see Figure 5). If all the votes from this source are removed, Steve Nissen is the clear #1 choice among US respondents and Rost is tied with Woodcock for #3 (see Figure 6). Who Voted for Whom? Up until this point we’ve looked at the overall results and haven’t broken them down by the affiliation of voters or by the level of industry support of voters. In the following analysis, we focus on the Top 5 contenders: Nissen, Rost, Wood, Woodcock, and Kessler. Figures 7A and 7B show two different ways to look at how different stakeholders voted. These charts Figure 3: Respondent Support of Drug Industry is High are based on ALL 475 respondents.

Among the general public (N=99), Rost is the Pharma Marketing Blog and to Pharma Marketing favorite with 32% of that group’s vote. Respon- Forums. Banners and other display ads were dents affiliated with the drug industry (Pharma + placed on these sites and within the newsletter. In Agency; N=146) preferred Woodcock and Kessler addition, several bloggers in the Pharma Blogo- who received 56% and 54%, respectively, of that sphere were asked to post notices about the group’s vote. Nissen is the favorite among aca- survey and notices were also placed in comments demics plus HCPs (N=143) with 44.9% of that to several blog posts and online news media group’s vote. Finally, among the government group articles. Each of these became “referral” sites that (N=51), Kessler, Nissen, and Wood are favorites could be tracked independently. with 18.9%, 16.9%, and 12.9%, respectively, of that group’s vote. And the Winner Is… Three of the most outspoken critics of the As you can see from Figure 8, voters for Janet FDAPeter Rost, Steve Nissen, and Susan Woodcock are the most supportive of the drug Woodtook an early lead in the survey. After two industry, whereas voters for Peter Rost are the days, the 5 leaders were: least supportive. Based on these results and those shown in Figure 7A, Wood, Kessler, and Nissen 1. Peter Rost are more “politically correct” (ie, middle of the road) 2. Steve Nissen in terms of support from the drug industry. 3. Susan Wood Write-In Candidates 4. Janet Woodcock and Robert Califf (tied for Respondents to the survey could also “write-in” fourth place) their candidates of choice and 21 did so. Among the write-in candidates were the following: Continues… © 2008 VirSci Corporation (www.virsci.com). All rights reserved. PMN710-04 Pharma Marketing News Pharma Marketing News Vol. 7, No. 10 p. 6

Figure 4: Who US Respondents Voted For. Rost blog referral votes included. Compare to Figure 6. For the results from ALL 475 respondents, see the online results summary: http://tinyurl.com/5ddk5r

Figure 5: Results by Referral Source. All = US and non-US respondents (N=475); PMN = Referrals from all Pharma Marketing Network sources (portal site, Pharma Marketing News subscribers, Forums site, and Pharma Marketing Blog; N=265); Rost = Referrals from multiple posts made by Peter Rost on his blog (N=93); EyeOnFDA = Referrals from post on Eye on FDA blog (N=24); Pharmalot = Referrals from Pharmalot blog comments (N=32); WSJ = Referrals from comments made to the Wall Street Journal health blog and to various WSJ articles (N=21); THCB = Referrals from post made to The Health Care Blog (N=20).

Figure 6: Who US Respondents Voted For, Excluding Rost Blog Referrals. Compare to Figure 4. Rost blog referrals (n=93) were removed from the total US vote to give these results (N=334).

Figure 7A: Who Voted for Whom by Affiliation of Voter. This chart looks at the voter profile of each of the Top 5 contenders.

Figure 7B: Who Voted for Whom by Affiliation of Voter. This chart looks at the voter profile of each of the Top 5 contenders.

Figure 8: Drug Industry Support Rating of Leading Candidates. This chart shows the average level of support of the drug industry of voters for the Top 5 contenders. Rating scale: very Supportive = +2; Somewhat Supportive = +1; Neutral = 0; Somehwhat Unsupportive = -1; Very Unsupportive = -2. Here are the ratings for the other 5 candidates: Califf: +1.08; Sharfstein: +0.50; Hughes: +0.81; Taylor: +0.85; Pendergast: +0.85.

• Michael Albano – former Mayor of Springfield, University. Now Managing Director of Sym- Massachusetts who began the first in the phony Capital LLC, a biopharmaceutical nation municipal prescription reimportation investment firm in New York City. Former program from Canada. chairman of the FDA’s Nonprescription Drugs • Marcia Angell – Senior Lecturer in the Depart- Advisory Committee. ment of Social Medicine at Harvard Medical • Diana Zuckerman – President of the National School and former editor-in-chief of the New Center for Policy Research for Women & England Journal of Medicine. Author of the Families. book "The Truth About the Drug Companies: Most of these contenders don’t have much chance How They Deceive Us and What to do About to be considered for the job FDA Commissioner. A It” (see http://tinyurl.com/6aphlg). few, however, have been mentioned as possi- • David Blumenthal – a professor of health bilities in the media and blogosphereeg, Frank policy at Harvard university and an adviser to Torti, Mark McClellan, David Graham, and David the Obama campaign. Blumenthal. • Ronald Chesemore – associate FDA commissioner for regulatory affairs. Comments from Voters and Candidates The survey asked respondents to comment on why • Howard Dean – former Democratic party they voted for specific candidates. The following is chairman. a selection from the 150 comments received as • David Egilman – practices medicine in well as statements made by candidates that reflect Massa-chusetts and is an associate professor their opinions regarding changes needed at the at Brown University. An expert witness in Vioxx FDA. and Zyprexa lawsuits. Let’s look at comments in support of the Top 5 • Scott Gottlieb (2 votes) – fellow at the contenders first. Comments attributed to identi- American Enterprise Institute for Public Policy fiable persons are published with permission. Research, a conservative think tank; former FDA deputy commissioner for medical and Comments in Support of Steve Nissen scientific affairs. The following comments were made by people who voted for Steve Nissen. Major attributes cited: • David Graham (3 votes) – associate director for science and medicine in the FDA's Office of • Stands up to pharma Drug Safety. In November 2004, Graham • Will clean house spoke out against the policies of the FDA, Committed to data, not bottom line claiming it was s "virtually defenseless" against • another "terrible tragedy and a profound • Patient advocate regulatory failure" like Vioxx. • Outsider • Allen S. Lichter – CEO of American Society of • Not a loon Clinical Oncology. “I believe Obama will want an outsider as FDA • Mark McClellan – former secretary of HHS. Commissioner, given their recent PR. Steve Nissen • David Ross – former FDA physician turned would be a safe choice for Obama.” -- Ross Weaver, whistle blower in Ketek case. President, Drug Development Insights, US, very supportive, agency, [email protected] • Jur Strobos – worked with Kessler at FDA as Director of the Policy Research Staff/Office of “He's a doctor, he's not scared to stand up to Policy in the Commissioner's Office pharma…He's intelligent, and the new commish should • Frank Torti – FDA's Principal Deputy Commis- clean house of the ‘insiders’ who have gotten too cozy sioner and first Chief Scientist; appointed by to big pharma.” – Anonymous, US, somewhat Andrew von Eschenbach, current FDA supportive, public Commissioner. “Dr. Nissen has consistently taken on the pharma- • Sydney Wolf – director of Public Citizen’s ceutical industry and the FDA. He is an excellent health issues division and frequent critic of the physician, knowledgeable, well-spoken, cour-ageous FDA. and above all, he represents the patients, which is what • Alastair J. J. Wood – professor of Pharma- the FDA is in business to do. I think he is a good fit if cology and Medicine, emeritus, at Vanderbilt he can handle the bureaucracy that is the FDA.” – Anonymous, US, very supportive, agency Continues… © 2008 VirSci Corporation (www.virsci.com). All rights reserved. PMN710-04 Pharma Marketing News Pharma Marketing News Vol. 7, No. 10 p. 10

“Has shown a willingness to use data regardless of the achieve some presumed beneficial goal.” “The consequences for the bottom line. Joshua Sharfstein ultimate purpose of that drug should be to prolong would be a very poor choice and his supposed life,” said Nissen. “So, isn’t that what we should be independence include two very super-ficial matters. It's measuring?” not hard to push for colored contacts to require a On the ideal candidate for FDA Commissioner: a prescription AFTER many have gone blind when they commissioner should be a physician, “because if were OTC. He's a poser...” – Anonymous, US, neutral, you haven’t ever taken care of patients, you don’t pharma really have the necessary perspective.” Next, the “He asks hard questions regarding drugs, and also cuts commissioner should be a “good scientist,” be- throught (sic) the smokey screen of adver-tising spin cause the FDA has to be a science-based organi- that occurs.” – Anonymous, US, somewhat supportive, zation, and “decisions have to be made upon the HCP basis of evidence.” The FDA commissioner also “ought to know something about statistics.” Finally, “Getting decisions to be made based on scientific he said, FDA needs a commissioner who is evidence, not policical (sic) sops to various interest “passionate about the public interests.” groups. Advocate for patients' rights. When ad-vocating for industry, he would be super-credible because he has “Frankly, it sounded an awful lot like him,” said been such a gadfly in the past.” – Anonymous, US, INVIVO bloggers, Michael McCaughan and Kate somewhat supportive, publisher Rawson. “He has a commercial mind, hands-on medical Comments in Support of Peter Rost experience, gets the data, and doesn't mind being The following comments were made by people unpopular. He is also a consumer advocate but not a who voted for Peter Rost. Major attributes cited: loon.” – Anonymous, US, very supportive, publisher • Change agent What Nissen Has to Say • Knowledge of industry Nissen has been on the lecture circuit lately sound- • Not cozy with drug industry ing like he is actively campaigning for the position Patient advocate of FDA Commissioner. Here is a synopsis from the • INVIVO blog and Pharmalot of some comments “The perfect poacher turned gamekeeper; knows all the Nissen made at a recent FDC-Windhover’s FDA/ tricks! – Anonymous, non-US, somewhat supportive, CMS Summit for Biopharma Executive (more here: HCP http://tinyurl.com/5fgagy and here: “Change is needed NOW within pharma and Peter is the http://tinyurl.com/5akqoq): person who can do it.” – Richard Meyer, consultant and On the issue of user fees: “As The Pink Sheet blogger (World of DTC Marketing; reports, Nissen—who, with some understatement, http://www.worldofdtcmarketing.com), US, somewhat observed that he is no fan of the Prescription Drug supportive, publisher (Meyer has publicly endorsed User Fee Act—nevertheless declared that, having Rost) taken the money, FDA needs to follow through by offering an answer in the agreed upon timeline.” “Dr. Rost has a unique combination of sterling qualifications for FDA Commissioner: knowledge of On FDA resources: “If you ask someone to do pharmaceutical medicine, knowledge -- both as an more than they have the resources to do, they’re insider and as a reformer -- of how the drug industry not going to succeed,” he said, citing the FDA’s IT actually works, knowledge of the political and legisla- system. “To ask FDA work with 10-year-old com- tive processes at work, and passion second to none for puters and then be speedy in how it does its work those things an FDA Commissioner should be most doesn’t make sense. (You can’t expect FDA to) “do concerned about -- the integrity of the pharmaceutical outstanding work on a poverty budget,” which he industry and how it affects the health and welfare of the described as a “national priority.” public.” - Anonymous, US, Somewhat supportive, publisher On the Critical Path Initiative: “It was well- intentioned, but it has not yielded any real serious “It is obvious we need the head of the FDA to be at difference.” odds with the drug companies that have run the FDA since Kessler's leaving. We need someone that knows On drug effectiveness/clinical trial endpoints: how they steal and corrupt. Only this way can we put an “Nissen,” Pharmalot reported, “said the agency end to it.” – Anonymous, US, neutral, HCP (retired) should more often require companies to prove their Continues… drugs save lives, rather than merely show they

“He's the only one on the list who hasn't yet let us down, dangerous system, the Wild West. We need to recognizes the need for safe and available drugs, has protect consumers from illegal and misbranded any ability to think outside the box of business as usual, drugs sold by Internet pharmacies. The only way to and doesn't play favorites with any one company over do it is to legalize and regulate this trade.” another or getting too cozy with the very industry mem- Comments in Favor of Susan Wood bers he would be called to regulate. Rost has demon- The following comments were made by people strated through his sacrifice of positions of power, who voted for Susan Wood. Major attributes cited: money and personal comfort that his integrity and con- cern for public health and safety isn't hollow lip-service • FDA experience to obtain votes or positions. He has truly put his money • Science trumps politics (and job, career, comfort, power & security) where his mouth is.” – Anonymous (student suffering from Crohn's “She has worked at FDA before, therefore is experi- Disease as a result of unsafe prescription drug), US, enced, and would work for Women's reproductive somewhat unsupportive, public health and follow her scientific knowledge and values, rather than the political pressures of any admin- “The FDA needs to work for the people and not the istration.” – Anonymous, US, very unsupportive, pharma companies and to keep its mission focused on academia the health and well-being of American consumers. Further, we need regulation of direct marketing via “Susan Woods has stated that she believes ‘the FDA television commercials, to consumers and to reduce must put an end to outside advisers with financial ties to influence of pharma companies on physicians and the drugs and other medical products they are recom- insurance companies.” – Anonymous, US, somewhat mending. It is unacceptable for the FDA to allow doc- unsupportive, public tors and scientists with stock in a company or consulting relationships with that firm to advise FDA to approve What Rost Has to Say that company’s new product. The FDA regulates one- In an interview with Cary Byrd of fourth of the American economy. The agency should be eDrugSearch.com, Rost expressed these views accountable to the American people, not to the com- (more here: http://tinyurl.com/64h8o4): panies it is supposed to regulate.’” – Paul Haider, On the issue of FDA preemption of state rights: Director of Information Services, Generations “My view is that no government agency, including Healthcare, neutral, public the FDA, should be considered the equivalent of “The FDA Commissioner appointee should be an ‘God.’ An FDA decision or lack of decision individual without ties to lobbyists, special interest shouldn’t preempt a legal challenge and an FDA groups, and big pharma. The FDA needs a complete decision or lack of decision shouldn’t be used as a overhaul of its top officials. Fresh officials with fresh legal shield. The FDA doesn’t know everything, ideas and the willingness to look at new therapies with doesn’t have all information, only what it receives fresh eyes are needed. The FDA has gone seriously from drug companies and doctors . . . quite frankly, astray in its evaluation of new drug/biologic license a decision in favor of preemption would be a applications, slavishly applying a form of statistical disaster for American consumers.” purity. As a result, many life-saving drugs are delayed On the issue of DTC advertising: “I used to be in in gaining approval for years. FDA needs a new com- favor of DTC and a ‘free market’ but a free market missioner who understands that FDA's role in efficacy requires informed consumers. Most of them don’t evaluation has evolved into a monster that the agency is have medical degrees; hence, most of them are not equipped to manage, has ignored Congress' intent, not qualified to judge and make decisions based and has poorly served patients by delaying marketing of on DTC advertising and, hence, DTC advertising is safe drugs that have been shown by good evidence to be not part of a ‘free market’—it is part of manipulation effective in prolonging life. Ultimately, patients are of consumers who don’t know better and doctors losing. The Provenge story is the poster child for what is who give the patient whatever they ask for. DTC wrong at the FDA.” – Melody Davis, Family Nurse advertising is not in the best interest of evidence- Practitioner, US, somewhat unsupportive, HCP, based healthcare or the American consumer.” [email protected] On the issue of Canadian drug reimportation: “I’m Comments in Support of Janet Woodcock in favor of regulated and legalized reimportation The following comments were made by people with access to these drugs through regular brick who voted for Janet Woodcock. Major attributes cited: and mortar pharmacies. Today we have a very Continues…

• Pragmatic, science driven “We need someone with little political motivation and • Integrity the focus on the patient safety and guidances that are up to date in the way business operates. Someone who is • FDA experience familiar with industry and how it works but who will Least political, favored by both democrats and • call the executives on the carpet when they knowingly republicans are pushing medicines for dollars not patient quality of “Dr. Woodcock is a scientist with a pragmatic approach life.” – Juanita Hawkins, President, Juanita Hawkins and in my opinion has great integrity. In my opinion the Consulting LLC, US, somewhat supportive, agency, issue at the top of her agenda should be addressing the [email protected] outrageous backlog of ANDA (generic drug) approvals, “Dr. Kessler's track record as former commissioner which would significantly decrease the nation's drug speaks for itself. The only blemish on his record in my costs.” – Anonymous, US, very supportive, gov’t view is the fact that the initial, PDUFA legislation was “She is the least political candidate and knows more enacted during his watch. However, I'm willing to give about FDA programs, operations, and human resources him a pass on that since I was not here at the time and than any other candidate. She is objective and does not don't know all the particulars.” – Richard C. Adams, suffer from a big ego.” – Anonymous, US, somewhat Deputy Director Div Chem II, Office of Generic Drugs, supportive, gov’t CDER/FDA, US, somewhat unsupportive, gov’t “Been there. Respected on all sides of the aisle. “Can ruffle feathers but is as pure as the driven snow. Unlikely to waste her time on tobacco issues.” – Extremely passionate about his work. Could be a Anonymous, US, very supportive, agency champion of the e-pedigree program. Would be most effective if Congress votes FDA control of tobacco; “President-elect Obama has already pledged to make which I would support.” – Anonymous, US, somewhat science a key element in public policy, and Dr. supportive, public Woodcock would advance that goal at FDA. Even outside of the Commissioner or Deputy Commissioner “Consumers need a revitalized watchdog and Kessler role, Janet Woodcock has been the quietly authoritative embodies that. The priority should be re-tooling FDA to voice of FDA for some time. She has been trying to be a regulatory (sic) agency, not the lapdog on bring more science to the Agency in general, and a more industry.” – Anonymous, US, neutral, gov’t scientific approach to the industry (which has been slow Comments in Support of Other Candidates to embrace some of the modern concepts that she and her team have put forth for the past eight years). She has “Any individual without ties to the Bush Adminis- also dedicated herself to bringing a more intelligent tration, von Eschenbach, or the current FDA leadership risk-based approach to regulation from R&D to post- would be a good choice. Anyone, particularly Janet manufacturing stages, through the Critical Path initia- Woodcock, would be an awful choice. The FDA tive, and other projects that she has quietly spearheaded requires leadership, and disenfectant. Woodcock offers and supported. During recent crises such as the heparin neither.” – Anonymous (voted for Sharfstein), US, incident this year, she showed a grace under pressure somewhat supportive, public that wasn't always visible at the very top level of the “Susan Wood & Joshua Sharfstein are the only people Agency. I think it's time for her to have the title she on the list who have demonstrated boat-rocking capa- deserves. We hear that industry supports her as candi- bility, and the FDA's boat needs rocking.” – Anonymous date, yet I think that she would be unbiased and science- (voted for Sharfstein), non-US, somewhat supportive, driven.” – Agnes Shanley, Editorial Director, Putman agency Media, US, somewhat supportive, publisher, [email protected] “His integrity is unassailable, he's extraordinarily smart, and he's a workaholic dedicated to getting results that Comments in Support of David Kessler benefit the public good.” – Anonymous (voted for The following comments were made by people Sharfstein), US, somewhat supportive, publisher who voted for David Kessler. Major attributes cited: “I think Bob is an excellent clinician, researcher, and • FDA experience leader. Additionally, he's worked extensively with • Knowledge of industry industry and I think the next Commissioner should have • Patient advocate a balance of attributes that will help him or her navigate “Dr. David Kessler performed exceptionally as the FDA the Agency better than it has been in the past.” – Neil Commish in the early 1990s. I'm sure he would do every Gray (voted for Califf), Managing Partner, Healthcare bit as good a job now.” – Anonymous, US, very Trends & Strategies, LLC, US, very supportive, agency supportive, agency Continues… © 2008 VirSci Corporation (www.virsci.com). All rights reserved. PMN710-04 Pharma Marketing News Pharma Marketing News Vol. 7, No. 10 p. 13

“Rob is brilliant and experienced. He has worked for pharma and as a physician and so knows both sides. He Pharma Marketing News has a moral center so will be able to decide based on Pharma Marketing News is an independent, free monthly facts not politics. His views on the world are electronic newsletter focused on issues of importance to progressive and he would not use science to advance a pharmaceutical marketing executives. It is a service of right wing agenda.” – Anonymous (voted for Califf), US, the Pharma Marketing Network, which brings together very supportive, agency pharmaceutical marketing professionals from manufacturers, communications companies, and Conclusions marketing service providers for wide ranging dis- This survey will not determine who the next FDA cussions and education on a multitude of current topics. Commissioner will be, but the results help us understand the wishes of various stakeholders and Subscribe Online • Download Media Kit • what they believe should be the qualifications of Request a Rate Card the next commissioner, whoever is nominated to fill that position. Publisher & Executive Editor It is particularly interesting that former FDA Com- missioner David Kessler is almost as popular as John Mack Janet Woodcock among pharmaceutical industry VirSci Corporation respondents. Perhaps it is not surprising that the www.virsci.com drug industry favors these “insiders” and not PO Box 760 Newtown, PA 18940 “change agent” outsiders like Nissen, Rost, or 215-504-4164, 215-504-5739 FAX Wood, who are favored by pharma’s customers: mailto:[email protected] the general public and healthcare professionals. It’s just another indication that the industry may not be ready for changes that their customers want to see.

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