Robert M. Califf, M.D., Commissioner
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Dear Commissioner Califf:
We are writing to express our deep concern regarding the lack of public health and consumer perspectives at the August 15, 2016 Public Meeting on Prescription Drug User Fee Act (PDUFA) Reauthorization and the lack of those perspectives in the commitment letter itself.
There were three stakeholder panels of invited speakers: to discuss post-market safety, regulatory decision tools, and administrative enhancements. Not one stakeholder on any of the panels was a consumer or public health advocate. Instead, the panels included only stakeholders from industry-affiliated patient groups as well as BIO and PhRMA representatives. Four of the five panel members on the first and third panels were on both panels. None of the panel members pointed out that the commitment letter, which is 46 pages long, included only 2 pages that mention patient safety. Not one of the panel members pointed out that the commitment letter, which is 46 pages long, included only 2 pages that mention patient safety.
We understand that the FDA is working hard to include more patient perspectives, but the vast majority of taxpayers who depend on the FDA for their health and who support the FDA with their tax dollars consider themselves consumers rather than patients, and are not affiliated with patient advocacy organizations that are primarily funded by pharmaceutical companies. Their voices are not being adequately heard or respected at the FDA. There are numerous public health advocates and researchers as well as consumer advocacy organizations that could represent the views of consumers at FDA meetings, but were not invited to do so. In addition, there are nonprofit patient organizations that are independent of pharmaceutical companies, many of which focus on safety and are members of the Patient, Consumer, and Public Health Coalition, and they were not included either.
At the August 15, 2016 Public Meeting on Prescription Drug User Fee Act (PDUFA) Reauthorization, our organization, the National Center for Health Research, commented on the commitment letter during the public comment portion of the meeting (see attached copy of our comments). Previously, we also attended all the PDUFA VI stakeholder meetings, and we participated in PDUFA IV and PDUFA V reauthorization cycles as well. If FDA was unable to find consumer or public health stakeholders to participate on the panels, the agency could have contacted our Center and we would have gladly produced a list of at least a dozen well-qualified potential participants.
FDA asked public comment speakers to state whether or not they had any financial conflicts of interest, but did not ask panel members to disclose any conflicts of interest, and none of them volunteered that information. That makes no sense. We strongly support disclosing conflicts of interest at FDA meetings for all participants who speak. When an organization advocates for faster FDA approval of medical products and less conclusive evidence of safety and efficacy by relying on surrogate endpoints and shorter and smaller clinical trials, the public has a right to know if that organization is tied financially to the prescription drug industry.
The August 15 PDUFA meeting is just the latest example of how public health researchers and experts, independent nonprofit patient organizations, and national consumer organizations representing millions of Americans are being excluded from FDA public meetings and FDA decision-making while patients with ties to organizations funded by industry are being used to support industry perspectives. FDA is repeatedly ignoring the views of academic researchers, public health advocates, and consumer groups. The unmistakable message is that the FDA does not value our views.
Sincerely,
Diana Zuckerman, PhD, President
cc: Dr. Janet Woodcock, Senator Lamar Alexander, Senator Patty Murray, Congressman Fred Upton, Congressman Frank Pallone