A coalition of health groups, including some that are backed by the pharmaceutical industry, have joined the heated lobbying battle over the next FDA commish by sending a letter to Health and Human Services Secretary-designate Tom Daschle urging him to pick a person familiar with the industry, The Wall Street Journal reports.

The newly formed FDA Commissioner Coalition is made up of 34 patient and research organizations, most of which receive funding from drugmakers, the paper writes. The coalition’s letter to Daschle didn’t name any candidates but argues the next commissioner should make decisions free from “pressure from elected and appointed officials and from the news media.”

The move comes after weeks of speculation that the list of potential nominees includes such controversial figures as Cleveland Clinic cardiologist Steve Nissen and Baltimore health chief Joshua Sharfstein, who is also leading President-elect Barack Obama’s team assessing the FDA (back story). Both have been outspoken in criticizing drugmakers over various products and practices. FDA Commish Andy von Eschenbach leaves on January 20 (look here).

In contrast to such public profiles, the coalition’s letter says relationships with industry should be viewed as a “positive qualification” for candidates, not as a black mark. A spokesman for Friends of Cancer Research, which signed the letter, says the coalition wants to reflect concerns of its members and didn’t coordinate its statements with drugmakers. “Our interest is the patients,” he tells the paper.

The Marti Nelson Cancer Foundation, which signed the letter, expressed concern Wednesday that “industry” wasn’t included in the list of entities threatening the agency’s independence. Bob Erwin, president of the California-based nonprofit that advocates greater access to experimental cancer drugs, tells the Journal that “I wish I had corrected the letter to include the importance of resisting pressure from companies, before signing.” Here is the letter…

Secretary Designate Thomas A. Daschle
451 Sixth Street, N.W.
Washington, D. C. 20004

Dear Secretary Designate Daschle:

As members of the nation’s broad patient and research advocacy communities, we believe one of the most important decisions facing the incoming Obama Administration is the appointment of a Commissioner of the Food and Drug Administration. We urge the early appointment of a Commissioner with impeccable qualifications in order to assure Americans prompt access to safe and effective medical products.

The number of Americans stricken with serious and life-threatening diseases stands at an all-time high. Those represented by our organizations will increase exponentially in the years ahead. Despite vast advances in basic understanding of the root causes of disease brought about by a doubling of biomedical research funding in recent years, a pipeline problem exists that is stifling innovation and denying patients access to the treatments they need. By the FDA’s own admission novel therapies are not moving through development and to patients as quickly as they should. Recent studies confirm that the number of new medical therapies reaching the marketplace is the lowest in decades.

Over time, expanded regulatory responsibilities for drugs, medical devices, and food, without accompanied financial resources have put the FDA mission of promoting and protecting the public health at risk. The dire straits of the agency’s scientific infrastructure have been documented by both the Institute of Medicine and FDA’s own Science Advisory Board. The FDA’s professional staff, which has a deep dedication to sound scientific decisions, is doing a remarkable job under these difficult circumstances. But in order to best equip FDA to regulate increasingly complex medical products and the rapidly evolving global marketplace, strong scientific leadership is needed.

Our organizations believe consistent and effective leadership at FDA during the Obama Administration can overcome many of FDA’s current problems and can increase confidence in its ability to balance public safety with timely patient access to new therapies. A candidate with the right mix of diverse experience and specific leadership qualities can renew this vital health agency. We believe the following characteristics should be paramount:

• The Commissioner should have excellent scientific credentials. This individual should be science driven and have experience managing projects that are translational in nature.

• The Commissioner must have proven managerial and administrative experience with the ability to execute effectively a forward-looking vision for the agency.

• The Commissioner should have the capacity to build consensus around key issues related to the evaluation of products under review by engaging various stakeholder groups, including patients and their representatives.

• The Commissioner must be capable of rising above politics to elevate the science of FDA by taking an impartial approach to complex issues, despite pressure from elected and appointed officials and from the news media.

• The Commissioner must also have a vision for the advancement of evidence-based science in the drug development arena as well as the regulation of new and existing therapies.

• Candidates for Commissioner should not be excluded due to relationships with industry during the course of his/her career. In fact, diverse experience, including that with an FDA-regulated industry, should be viewed as positive a qualification.

By appointing a Commissioner possessing these qualities, the Obama Administration can demonstrate that it places a premium on meeting the urgent needs of Americans facing serious and life-threatening medical challenges. Our organizations feel there are a number of highly qualified individuals dedicated to public health who exemplify these principles. We respectfully ask the Obama transition team and President-elect Obama’s choice for Secretary of Health and Human Services to consider such candidates for this important position. Our organizations are ready to discuss this matter further with transition officials if that would be helpful and productive.

Sincerely,

Alliance for Aging Research
ALS Association
American Association of Cancer Institutes
American Association for Cancer Research
American Association of Neurological Surgeons/
Congress of Neurological Surgeons
American Cancer Society-Cancer Action Network
American Society of Clinical Oncology
C3: Colorectal Cancer Coalition
FasterCures
Friends of Cancer Research
Intercultural Cancer Council Caucus
Kidney Cancer Association
Leukemia & Lymphoma Society
Lung Cancer Alliance
Marti Nelson Cancer Foundation
Men’s Health Network
National Alliance on Mental Illness
National Coalition for Cancer Research

National Health Council
National Minority Quality Forum
National Multiple Sclerosis Society
National Patient Advocate Foundation
Ovarian Cancer National Alliance
Parkinson’s Action Network
Prevent Cancer Foundation
Research!America
RetireSafe
Sarcoma Foundation of America
Society for Women’s Health Research
Society of Gynecologic Oncologists
Susan G. Komen for the Cure
Treatment Action Group
WomenHeart

Cc: John Podesta
R. Alta Charo
William Corr
Neera Tanden
Mark Childress