October 26, 2010
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Dear Commissioner Hamburg:
As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our concerns about the FDA’s policies and practices regarding FDA Advisory Committee meetings.
Advisory Committee meetings are a very important way for the FDA to show the public how they make decisions and value input from independent scientific experts and the public. In this letter, we will make suggestions about how to improve the Advisory Committee meeting process in general, and then focus on ways that the public comment period could be easily improved. Many of us have testified during the public comment periods at numerous FDA Advisory Committee meetings over the years, and some experiences were better than others. However, some policies have taken a turn for the worse in the last year or so. In other cases, the FDA’s recent stronger focus on scientific evidence and public health is inconsistent with the experience of attending an FDA Advisory Committee meeting.
We strongly urge you to improve the Advisory Committee process in the following ways:
- Ensure that most Committee members have an understanding of statistical significance and an appreciation of scientific analysis. At some meetings it seems that the majority of members do not understand the statistics or the scientific information being presented. Instead, they focus on their own clinical experiences and those described by the sponsor. Although clinical experience is valuable, anecdotal data should not replace scientific expertise for Committee members.
- The FDA should provide a more neutral environment for Advisory Committee deliberations. FDA’s desired outcome is often quite obvious by the way questions that the Advisory Committee will vote on are worded. Moreover, at some meetings, FDA officials make it very clear how they want Committee members to vote. At some meetings, the chair does not seem independent of FDA staff and seems to be pushing the vote in a particular direction with his or her comments and the way they manage the time spent on questions or comments.
- Include independent researchers as invited presenters at Advisory Committee meetings. Those independent experts could add important information that is unlikely to be provided by sponsors or FDA staff.
- Give Consumer Representatives a vote at all Advisory Committee meetings, including CDRH meetings.
- Select Consumer Representatives who truly represent consumer advocates with knowledge of the FDA process and the specific products under review. Some Consumer Representatives are health professionals, which is fine if they are truly advocates for consumers, but not if they merely represent their professional perspectives.
As patient, consumer, and public health experts, our participation in Advisory Committee meetings is often during the public comment period. The Chair usually explicitly introduces the public comment period as an important way to give the public an opportunity to speak, and at some meetings they even mention the importance of treating speakers with respect. Unfortunately, there is an enormous gap between those words and how public comment speakers are treated.
Many patients, consumers, and public health advocates who have presented during the public comment period have told us how disrespected they feel, as if their opinion doesn’t matter. They often question whether anybody on the committee was listening. Speakers who have come from out of town at their own expense especially feel that they have wasted their time and money. Here are a few examples of simple changes that would make public comment speakers feel more valued:
- Locate public speakers at a lectern near the Advisory Committee members, so that they can speak to them as other presenters do. At virtually all FDA Advisory meetings, there is a podium/lectern for the invited speakers that is close to the committee members. Public speakers should be able to use the same podium/lectern. That would be a great way for the FDA to show that the public comment speakers are an important part of the meeting.
- Do not shut off the microphone when the speaker’s time has just expired. We understand the need to stay close to the time allotted, but it would be less disrespectful for the chair to politely interrupt by saying “your time has expired, please just finish your sentence.” Then, the microphone could be cut off. It is especially frustrating to be cut off mid-sentence when there is a considerable amount of time left over in the public comment period that was set aside.
- Public Comment speakers should be given at least 5 minutes to speak, unless more than 20 speakers are signed up and present. Often, public speakers are given only 3 or 4 minutes to present, even if an hour has been set aside and 10 speakers or fewer have signed up and fewer have shown up. Since inevitably some speakers will not show up, allocating 5 minutes to 20 speakers or fewer would mean that most public comment periods would still be less than one hour long. We also ask that public speakers be told in advance how much time they will have. It would be appropriate to increase the amount of time if several speakers are absent, but the time allocation should not be decreased. At several Advisory Committee meetings, we have been told at the last minute that our time has been cut, giving us no time to prepare shorter remarks. The result: even the most experienced speaker has to speak too quickly or is unable to finish. Neither is conducive to sharing information with committee members.
- Advisory Committee members should be encouraged to ask questions of the public comment speaker. Even when each speaker’s time includes an estimated 2 minutes set aside for questions, speakers during the public comment period are almost never asked questions. Even the most knowledgeable, articulate, or provocative speakers are rarely asked any questions. Speakers who are asked questions are almost always friends or colleagues of a committee member, or represent a medical association. The lack of questions for public speakers adds to the perception that their views are not valued. We have heard from advisory committee members that they are sometimes instructed not to ask questions during public comment periods in order to help keep the public comment period as short as possible. At most Advisory Committee meetings, the chair doesn’t ask the Members if they have any questions, or even mention at any time that asking questions of public comment speakers is an option.
- Provide FDA summary documents written for the Advisory Committee to the public online at least one week in advance of the meeting, and before the written comments are due. Currently, the written public comments and PowerPoint presentations are due to the FDA staff before the public is given information about the data to be presented at the meeting. In addition, individuals without ties to the sponsor have only 48 hours (sometimes less) to prepare their public comment statements if they want to comment on the scientific findings of the products under review. In contrast, individuals with connections to the sponsor have access to the sponsor’s data in advance.
- Allow two speakers to combine their time and give it to one speaker. At some meetings, some speakers are given more than twice as much time as other speakers. Sometimes (but not always) that is explained by the chair that several speakers combined their time and the testimony would be given by only one of them. That is a reasonable thing to do, but everyone should be told by the FDA in advance that they have that option, not just the one person who apparently asked for it.
- When the agenda of any FDA public meeting includes time where the public could ask questions, make sure there is enough time for several questions. At some meetings, the chair decides to only let one or two people to ask questions of the several people lining up to do so. The excuse was that since the meeting was running a bit late, the public would not be able to ask questions. An example of that was last year at the Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Public Workshop.
- Choose locations that are accessible by public transportation, have sufficient opportunities for a quick lunch, and provide free or low-cost parking. Many recent meetings have been held at the University of Maryland Conference Center, which fails on all three of these criteria.
- Reserve seats for people making public comments. This is usually done, but not always. It saves time and shows respect for people who have signed up to participate.
- If the chair is going to offer anyone in the audience time to speak at the end of the public comment period, do not rush the people who signed up to speak in advance.
These suggestions would have improved the experience of public comment speakers at many FDA meetings during the last 20 months, including several recent meetings on diet pills and drugs for anemia, where the public speakers’ microphone was shut off after their designated 4 minutes, even if the speaker was in the middle of a sentence. The meetings were all located in the University of Maryland Conference Center, which is convenient for FDA employees but as noted above is inconvenient for many others who would like to attend.
Last year, at an Advisory Committee meeting on Seroquel, one young woman was shut off mid-sentence while tearfully concluding her remarks about the death of her husband, a veteran of the Iraq war who died suddenly while taking Seroquel for PTSD. None of us like being cut off mid-sentence, especially when given such a short amount of time to speak, but it seems even more disrespectful when crying widows of veterans are cut off – especially given that there was quite a bit of time left over of the block of time designated for the public comment period. The overall impression is that public speakers are required to be included, but not a respected part of the process.
In summary, we ask you to improve Advisory Committee meetings so that they are more balanced as well as scientifically sound. In addition to giving a vote to Consumer Representatives who are knowledgeable and trusted advocates for consumers, we urge you to add truly independent experts as invited presenters and that you ensure that FDA staff do not unduly influence Advisory Committee members. Moreover, we believe it would be an easy matter to treat the public comment speakers with greater respect. That should include giving them a reasonable amount of time to speak, allowing people who truly represent the public to combine their times so that one person has more time to speak, asking presenters to finish up their remarks rather than cutting off their microphones, allowing public speakers to use the same lectern as other speakers, and ensuring that Advisory Committee members ask questions of at least a representative sample of those testifying during the public comment period.
Annie Appleseed Project
Center for Medical Consumers
Community Access National Network
Consumer Federation of America
Government Accountability Project (GAP)
Jacobs Institute of Women’s Health
National Consumer League (NCL)
National Research Center for Women & Families/Cancer Prevention and Treatment Fund
National Women’s Health Network
Our Bodies Ourselves
THE TMJ Association
Truth in Medicine