I really had to laugh when I read Dr. Lurie's "troubling" qualifications.
21 October 2009
Sue Sutter,SCRIP
US FDA commissioner Dr Margaret Hamburg has announced a number of new senior staff hires who bring with them expertise in public health and consumer advocacy, Democratic sympathies and prior FDA and congressional experience.
In announcing the new appointments in an email to staff, Dr Hamburg said that when she arrived at the FDA in May she was impressed with the agency's staff of "terrifically dedicated and experienced leaders, in whom I have great confidence. However, the challenges of improving the FDA's science base and capacity to protect the public are enormous. We have been searching for additional talent that can complement all that you are now doing."
Perhaps the most surprising appointment, and the most troubling to the pharmaceutical industry, is that of Dr Peter Lurie, who will work in the office of policy to develop strategies facilitating medical product availability to meet critical public health needs.
Dr Lurie most recently was deputy director of Public Citizen's Health Research Group, where he worked closely and was a frequent co-author with director Dr Sidney Wolfe in pushing for greater FDA oversight of drug safety, increased transparency into agency decision-making and disclosure of payments from pharmaceutical companies to doctors.
Dr Wolfe currently serves as the consumer representative on the drug safety/risk management advisory committee. Bringing Dr Lurie inside the agency gives a well-known consumer advocate a role in internal development of agency policy.
In June, Dr Lurie testified before the agency's transparency task force in favour of public disclosure of documents for drug applications still under FDA review. He has had a keen interest in the advisory panel process as well, testifying against product approvals for safety reasons and criticising what he called the FDA's "sub-optimum" use of the advisory committee process in The Lancet in December 2006. He also authored a 2006 paper in the Journal of the American Medical Association that reported a weak but statistically significant link between certain types of financial conflicts of interest and voting patterns among advisory committee members.
Peter Pitts, president of the Center for Medicine in the Public Interest and partner/director of global healthcare for Porter Novelli, commented on the centre's DrugWonks.com blog that Public Citizen's "well-known position on 'medical product availability' is that most products are 'too dangerous'".
Another recent addition to the office of policy is R Alta Charo, who is on leave from her position as a professor of law and bioethics at the University of Wisconsin. Part of the Obama-Biden transition team last year, Ms Charo participated in the incoming administration's review of the health and human services department and focused on issues involving the National Institutes of Health, the FDA, bioethics, stem cell policy and women's reproductive health. She also was a member of the Institute of Medicine committee that issued a harsh critique of the FDA's drug safety oversight in 2006.
Ms Charo is serving as a senior advisor on a range of issues involving emerging technologies, such as genetics, biotechnology, nanotechnology and synthetic biology.
Two former FDA staffers are returning to the fold. John Taylor leaves his position as executive vice-president for health at the biotech trade group BIO to take a new position as counsellor to the commissioner. He will oversee the FDA's crisis response functions and advise on a range of policy and regulatory matters.
Prior to joining BIO in 2007, Mr Taylor was divisional vice-president for federal government affairs at Abbott Laboratories, a position he assumed after working at the FDA for 14 years as a staff lawyer, advisor to previous commissioners and associate commissioner for regulatory affairs.
Ann Witt also rejoins the agency as counsellor to the deputy commissioner for policy. She previously worked as an agency staff attorney and advisor, and headed the drugs centre's division of drug marketing, advertising and communications (DDMAC). For the past six years she served as counsel to California Democratic representative Henry Waxman and the House energy and commerce committee. Principal deputy commissioner Dr Joshua Sharfstein, who joined the agency in March, is also a former Waxman staffer.
Another former House energy and commerce staffer, Jeanne Ireland, is the agency's new assistant commissioner for legislation. She was previously director of public policy for the Elizabeth Glaser Pediatric AIDS Foundation and minority staff director for the Senate health committee's subcommittee on children and families.
Dr Vicki Seyfert-Margolis joins as an advisor to FDA acting chief scientist Dr Jesse Goodman in upgrading science at the agency, with a focus on bioinformatics. She most recently served as chief scientific officer for the Immune Tolerance Network, a non-profit consortium of researchers seeking new immune system treatments.
Meghan Scott has been named the agency's new chief press officer, responsible for daily press operations in the office of public affairs. She was previously campaign director for a union project and communications director of the plaintiffs' lawyers group American Association of Justice.
21 October 2009
Sue Sutter,SCRIP
US FDA commissioner Dr Margaret Hamburg has announced a number of new senior staff hires who bring with them expertise in public health and consumer advocacy, Democratic sympathies and prior FDA and congressional experience.
In announcing the new appointments in an email to staff, Dr Hamburg said that when she arrived at the FDA in May she was impressed with the agency's staff of "terrifically dedicated and experienced leaders, in whom I have great confidence. However, the challenges of improving the FDA's science base and capacity to protect the public are enormous. We have been searching for additional talent that can complement all that you are now doing."
Perhaps the most surprising appointment, and the most troubling to the pharmaceutical industry, is that of Dr Peter Lurie, who will work in the office of policy to develop strategies facilitating medical product availability to meet critical public health needs.
Dr Lurie most recently was deputy director of Public Citizen's Health Research Group, where he worked closely and was a frequent co-author with director Dr Sidney Wolfe in pushing for greater FDA oversight of drug safety, increased transparency into agency decision-making and disclosure of payments from pharmaceutical companies to doctors.
Dr Wolfe currently serves as the consumer representative on the drug safety/risk management advisory committee. Bringing Dr Lurie inside the agency gives a well-known consumer advocate a role in internal development of agency policy.
In June, Dr Lurie testified before the agency's transparency task force in favour of public disclosure of documents for drug applications still under FDA review. He has had a keen interest in the advisory panel process as well, testifying against product approvals for safety reasons and criticising what he called the FDA's "sub-optimum" use of the advisory committee process in The Lancet in December 2006. He also authored a 2006 paper in the Journal of the American Medical Association that reported a weak but statistically significant link between certain types of financial conflicts of interest and voting patterns among advisory committee members.
Peter Pitts, president of the Center for Medicine in the Public Interest and partner/director of global healthcare for Porter Novelli, commented on the centre's DrugWonks.com blog that Public Citizen's "well-known position on 'medical product availability' is that most products are 'too dangerous'".
Another recent addition to the office of policy is R Alta Charo, who is on leave from her position as a professor of law and bioethics at the University of Wisconsin. Part of the Obama-Biden transition team last year, Ms Charo participated in the incoming administration's review of the health and human services department and focused on issues involving the National Institutes of Health, the FDA, bioethics, stem cell policy and women's reproductive health. She also was a member of the Institute of Medicine committee that issued a harsh critique of the FDA's drug safety oversight in 2006.
Ms Charo is serving as a senior advisor on a range of issues involving emerging technologies, such as genetics, biotechnology, nanotechnology and synthetic biology.
Two former FDA staffers are returning to the fold. John Taylor leaves his position as executive vice-president for health at the biotech trade group BIO to take a new position as counsellor to the commissioner. He will oversee the FDA's crisis response functions and advise on a range of policy and regulatory matters.
Prior to joining BIO in 2007, Mr Taylor was divisional vice-president for federal government affairs at Abbott Laboratories, a position he assumed after working at the FDA for 14 years as a staff lawyer, advisor to previous commissioners and associate commissioner for regulatory affairs.
Ann Witt also rejoins the agency as counsellor to the deputy commissioner for policy. She previously worked as an agency staff attorney and advisor, and headed the drugs centre's division of drug marketing, advertising and communications (DDMAC). For the past six years she served as counsel to California Democratic representative Henry Waxman and the House energy and commerce committee. Principal deputy commissioner Dr Joshua Sharfstein, who joined the agency in March, is also a former Waxman staffer.
Another former House energy and commerce staffer, Jeanne Ireland, is the agency's new assistant commissioner for legislation. She was previously director of public policy for the Elizabeth Glaser Pediatric AIDS Foundation and minority staff director for the Senate health committee's subcommittee on children and families.
Dr Vicki Seyfert-Margolis joins as an advisor to FDA acting chief scientist Dr Jesse Goodman in upgrading science at the agency, with a focus on bioinformatics. She most recently served as chief scientific officer for the Immune Tolerance Network, a non-profit consortium of researchers seeking new immune system treatments.
Meghan Scott has been named the agency's new chief press officer, responsible for daily press operations in the office of public affairs. She was previously campaign director for a union project and communications director of the plaintiffs' lawyers group American Association of Justice.