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How Can FDA Use its Website to Improve Transparency at the Agency?
On June 24, we held our first public meeting to hear ideas from the public about transparency at the agency. During the meeting, some attendees told us that the FDA should use its website, www.fda.gov, to improve communications with the public. The task force would like continue this conversation and hear from more people about how FDA can use the website to be more effective in providing useful and understandable information to the public.
Our question is:
How can FDA use its website to improve transparency at the agency?
Thank you and we look forward to your input and participation.
FDA Transparency Task Force
I would like to see greater use of RSS feeds. It would be great to be able to get an RSS feed for types of adverse event reports instead of having to routinely check the MAUDE database. This would also be useful for product approvals or clearances and warning letters.
The FDA is awesome; overall the FDA does a terrific job, but I have a couple of suggestions for improvement.
First, please have the latest FDA approvals listed on the same day as they are approved on your website; we’d appreciate having the most current FDA approval news on the FDA website as various big drug companies. Why do they get notified before American citizens, the consumers?
Lastly, is the FDA open on July 3, 2009? The FDA should post their hours of operation; and dates they are closed/open on the FDA website. Thank you for your understanding and assistance.
Remodeling the FDA.gov was only a first step in the right direction. I believe that further consolidation of information would make this web page more user friendly. There is still a bewildering and confusing array of choices on the FDA home page. The criteria that were used to group the links are not clear and do not seem to be logical.
* I would suggest:
– subdividing the links into four main groups
1)consumer information,
2)industry information,
3)information for doctors
4)FDA mission, regulations and about FDA
– “News and events” should be a single link to a separate page that lists all the news and provides a link to archives. The current news section has only selected news for the last few days.
– Get rid of the the “science and research” by spreading its content over the four main groups.
– Combine “public health focus”, “report a problem” and “recalls and alerts” into “Public health and safety” category. Remove this category from the Home page. Link to it separately from the pages for Patients and Doctors.
– Remove the category “Multimedia” and spread its content over the four main categories.
* I would like to illustrate how confusing the current organization of the FDA home page is by using an example.
1) A doctor wants to read FDA’s recent update on insulin glargine.
2) He clicks on the Newsroom->Newsroom->Press announcements… And finds nothing there.
3) He tries Health Professionals.Drugs->Public health advisories->2009 Public Health Advisories… Nothing there.
4) He tries Spotlight. Drug safety information for providers & patients.-> There are 34 links in no particular order. No time to look through them…
5) He goes to Recalls and Safety alerts… Wrong again.
6) In desperation, he goes to Search and types “insulin glargine”. The first two links are to the correct pages.
The morale: your search engine is good, while the organization of the links and of the home page needs much improvement.
* There are companies who specialize in usability testing. Outsourcing the job of running the focus groups and optimizing your home page to them could be an alternative to asking the public directly.
Thanks for this opportunity to provide suggestions. As the CEO of the Indie Beauty Network, a trade organization representing small and independent cosmetics manufacturers, I have two suggestions:
1. Use your website to create an easy way for people to find out about Notices of Inquiry, Notices of Proposed Rulemakings and other proceedings. The federal register is great, but many very small businesses don’t even know it exists. This results in missed deadlines while the regulatory process proceeds to conclusion and new rules affecting their businesses are promulgated without their knowledge or input. If there was a way to use RSS to share federal register posts when they involve the FDA, that would be a great help to the American small businesses owner.
2. Use your website to provide the public with details on industry meetings with FDA officials. So much of the regulatory process depends on what is shared at these meetings, and with whom and by whom. The fact they have occurred, who was present and what was discussed (generally) should be easier to find. It would be helpful for all industry participants, especially small business owners.
Thank you again for allowing submission of suggestions. I’m looking forward to how this blog creates agency accountability, supports affected industries and furthers the public interest.
The News on the FDA website would only win if the direct and timely links to the supporting materials are provided in the news item. In that I agree with a comment above by Citizen Opinion that the FDA does not fully use the advantages provided by the Web medium.
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Example: news release on Chantix and Zyban http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm.
* This excellent news item does provide two separate links for the healthcare professionals and for the public.
* The usefulness of this press release can be further enhanced by adding
- Link to the audio file of the conference call with reporters. The conference took place several days ago but the file still has not been posted.
- Direct link to the Drug Safety Newsletter with the details on this topic. http://www.fda.gov/downloads/Drugs/DrugSafety/DrugSafetyNewsletter/UCM107318.pdf
- Link to the FDA analysis of the issue (supporting materials) from the news item itself or from the helthcare professionals page. Scanning the FDA analysis to the PDF format and proofreading should not take more than a few hours. (Other supporting materials such as the correspondence with the industry that require redaction may wait).
– This will help the public health professionals in revising their recommendations. Nicotine patch has no suicidality adverse effect and is likely to be recommended as the first-line treatment to smoking cessation. Zyban and Chantix may be relegated to the second-line treatment.
– This will prevent the suggestions of undue industry influence from the FDA detractors. Chantix is a proprietary drug from Pfizer, Zyban (bupropion) is a generic and much cheaper drug. Zyban appeared to have about the same number of reported suicidality cases over 10 years as Chantix over 1 year. Indepentently, a 2007 Cochrane review http://www.ncbi.nlm.nih.gov/pubmed/17253443 concluded, “Concerns that bupropion may increase suicide risk are currently unproven.” I am sure that these points were addressed in the analysis done by the FDA scientists. Releasing the FDA analysis will nip the conspiracy theories in the bud.
In response to comment by Donna Maria Coles Johnson: “provide the public with details on industry meetings with FDA officials. So much of the regulatory process depends on what is shared at these meetings, and with whom and by whom. The fact they have occurred, who was present and what was discussed (generally) should be easier to find.”
Please look at http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/PastMeetingsWithFDAOfficials/2009PublicCalendars/default.htm. The information you request is already available there.
As a person interested in comment letters submitted to FDA, I miss the old days of “Docket Management” where submitted comments were posted on-line and shared with interested parties through electronic mechanisms.
Link: http://www.fda.gov/ohrms/dockets/dailys/dailys01.htm
People don’t go to the offices to seek hard copies of submitted comment letters. Docket dailys were important for stakeholders and added value to the overall regulatory process.
Please consider reviving this service to the public. While it might be grunt work, it was effective for its intended purpose to educate the public and be transparent about what was considered by the agency in rule making process.
Thank you for the opportunity to comment.
What would really help the public is if you published firms that are under investigation. This information is critical as the public needs to be informed. Whether it’s a pet food manufacturer or a medical device company, the public has the right to know, regardless of the outcome.
I would like to see the FDA post on its website all presentation materials (PowerPoint) provided by FDA personnel to the public, trade associations or other groups. As these conferences are quite expensive and considering the state of the economy it would be very helpful to the small business folks.
Engage in discussion with readers. Maybe hold regular question and answer times in live chat rooms.
Overall, the FDA is doing very well in terms of transparency. One suggestion I do have relative to the website is that, in addition to webcasting meetings, if it is not already doing so, the agency might consider a teleconferencing option so that all interested parties may participate from any location. In this way, participants benefit from direct, real-time interaction with FDA personnel, which in turn promotes greater communication between the agency and the general public.
I’m not sure if this is feasible, but I know there has to be some sort of investigating going on toward products that may or may not be healthy. They’re not yet banned or anything like that, but it would interesting if that information could be posted for the public to see.
Regarding the people on advisory committees – there used to be links on the roster of each committee that would take one to the CV’s of each member. A check this week on all the CDER committees revealed that 50% of the members of the committees have no links at all to their CVs. Why has the access to the back grounds of members been compromised?
For your blogs, you may consider adopting the format the Office of Science and Technology Policy uses in their blog (see for example, http://blog.ostp.gov/2009/06/12/improving-online-public-participation-in-agency-rulemaking/).
The participants are allowed to comment on each other posts, and the moderator from OSTP sometimes answers them. The posts are grouped in threads so that they are easier to read. In addition, participants are able to rate good and bad posts by “plus” or “minus”.
In my opinion, investigating of products that may or may not be healthy should be done more often and should be open to public
I’ve noticed that the GCP compliance sites (NOOH, NIDPOE…) have changed a lot, actually becoming less transparent. For example, the NIDPOE letters are now in alphabetical order which makes it very difficult for us to know when a new NIDPOE letter is added. Could a NEW flag be added or could you go back to adding them chronologically?
I would like to see more information for patients and doctors on the exact amount of drugs in generic prescriptions. No more 85-125% rule, but equal contents of equivalent drugs. Too many times I’ve had to deal with inferior generics by companies well known to my drs that certain companies have such drugs. Transparency shouldn’t be a cover-up for the well being of patients at the bottom end of the chain. The FDA needs to do more and expect more from generic makers.
Thank you for this opportunity to suggest ways in which FDA can improve its transparency. I have several things I’d like to say so I may post a couple of times.
My first suggestion would be for FDA to publically post “individual consumer” comments on the regulations.gov site. I recently submitted two comments for docket FDA-2008-N-0429 (Food Labeling; Current Trends in the Use of Allergen Advisory Labeling: Its Use, Effectiveness, and Consumer Perception; Public Hearing; Request for Comments).
Although “individual consumer” comments are available for FDA to review, I feel the voices of individual consumers were largely silenced since those comments could not be viewed by others like food manufacturers and the larger international community (where, for instance, they might have influenced changes being considered for the VITAL system).
I think it would be entirely reasonable to perhaps post “individual consumer” comments last after other comment categories and I would not object to them being stored at regulations.gov for less time than other comment categories, but I do think they should see the light of day.
I ended up having to file a FOIA request and have begun posting some of the “individual consumer” comments at websites like about.com. I think consumers had some good ideas and I would like the voices of consumers to be heard. I also think the posting of these comments will make FDA more responsive and accountable to the public.
My other suggestion would be for FDA to provide the contact information for somebody at FDA the public can get in touch with if they feel FDA has done something wrong or is not fulfilling its obligations to the public. This person or group of people should be knowledgeable, fair, detached from the alleged problem, a good listener, and somebody who is not necessarily going to try to defend the agency’s actions.
This might help catch issues early such as putting “politics ahead of science” or safety problems (Reference: “RPT-UPDATE 1-Obama’s US FDA pick wins Senate clearance” by Lisa Richwine available at http://www.forbes.com/feeds/afx/2009/05/18/afx6437782.html ).
It would also be helpful for when somebody feels their questions or concerns are not being adequately addressed by FDA. I realize this may present some challenges as FDA does not have unlimited resources to discuss in length every area of concern the public may have, and I’m not sure how to strike the right balance. However, as it stands now, it is too easy for FDA employees to essentially ignore questions and concerns from the public.
Below is an example of something that seems unfair to me.
The following language is found in the official notice language for Docket ID: FDA-2008-N-0429:
“II. Purpose and Scope of the Hearings FDA is developing a long-term strategy to assist manufacturers in using allergen advisory labeling that is truthful and not misleading, conveys a clear and uniform message, and adequately informs allergic consumers and their caregivers. To that end, FDA is soliciting comments and information to assist the agency in determining how manufacturers currently use advisory labeling, how consumers interpret different advisory labeling statements, and what wording is most effective in
communicating to consumers the likelihood that an allergen may be present in a food. …
The scope of this hearing is determined by this document.”
However, in the transcript of the public meeting for this docket, an FDA employee uses different language:
“the purpose of the meeting today is for F.D.A. to gather information that will help us develop a long term strategy that can assist manufacturers in using allergen advisory labeling that is truthful and not misleading and conveys a clear and uniform message and adequately informs food allergic consumers and their caregivers to the potential presence of a major food allergen.”
I am admittedly not a lawyer, but it does appear to me that FDA attempted to change the stated scope of the hearing from dealing with “allergens” to “major food allergens”. I do not know if this is legal, but I do not believe it is fair. What I think probably happened is that FDA was surprised that a large percentage of the public comments submitted for this docket mentioned allergens other than those covered under the FALCPA.
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I welcome the new, refreshed look for the site and the updated navigation, too, it seems more user-friendly and intuitive. A suggestion would be to have more focus on discussion and two-way communication on the site. As well as ‘adding value’ for visitors, it helps to improve transparency and can also be a very cost effective way of dealing with enquiries.
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I welcome the new too. Engage in discussion with readers. Maybe hold regular question and answer times in live chat rooms.
I would like the FDA to be more open about alternatives to using drugs only as the solution to sickness in this country. Vitamins usage has its place as well, however all I ever hear is negative or misleading information which some people believe to be somewhat biased. For example, in smoking cessation products I read a great non-drug article at Articles On Smoking.
The FDA is awesome; overall the FDA does a terrific job, but I have a couple of suggestions for improvement.
First, please have the latest FDA approvals listed on the same day as they are approved on your website; we’d appreciate having the most current FDA approval news on the FDA website as various big drug companies. Why do they get notified before American citizens, the consumers?
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