FDA should launch a separate consumer website that serves as a one-stop shop for reliable and up-to-date drug risk and adverse event information, panelists suggested at a Dec. 7-8 FDA public hearing on the communication of drug safety information.

"If the FDA website is supposed to be for consumers, the way it is right now, I think it's very difficult for most consumers, except for maybe the most educated consumers, to use in some sort of reasonable way....Why not have a website that's just for consumers?" National Research Center for Women & Families President Diana Zuckerman said.

[Editor's note: To ¹ watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]

FDA's website currently focuses too heavily on the agency's drug regulatory processes and not enough on conveying drug risk information in consumer-friendly language, panelists noted.

Upon visiting ² www.fda.gov, "you can find the history of the drug, when it was approved and when changes to the label were made. But of course, the consumer isn't interested in that," Zuckerman said. "[Consumers] want to know...the most up to date information. They want it simple. They don't want this enormous process and all this detailed information."

Panelists observed FDA's website presented an overwhelming amount of data that is neither organized for consumer usability, nor updated regularly. For example, FDA's online consumer information sheet for Ortho-McNeil's once-a-week birth control patch OrthoEvra (ethinyl estradiol/norelgestromin) was posted in 2002 and revised in 2003, Zuckerman pointed out.

Additionally, she cited several FDA-issued public health advisories that are outdated, display the incorrect date or are not dated at all. "If the FDA can't figure out what their own information is dated then it's a sad state of affairs," Zuckerman said.

She further suggested FDA's patient information sheets be linked MedWatch and used as a tool to glean patient adverse reaction information. "Patient information sheets provide an excellent opportunity to promote the MedWatch system....In order to obtain a more realistic idea of adverse events, FDA should actively encourage reporting directly from patients," she said.

"To achieve this, FDA needs to add a consumer portal to the existing system and then promote the system's new features to consumers," Zuckerman suggested.

FDA ultimately "needs professional help" with its website, Plain Language Action & Information Network Chair Annetta Cheek said, criticizing FDA's website as "hard to navigate," the web pages as "too complex," and the lists of information as "too long."

Additionally, FDA's patient information sheets are "aimed at multiple audiences. Each document, each page, needs to go to one audience, or you don't serve any audience well," Cheek said.

"There is no place for one audience to go to get all the information they need....There is similar material in many different places," she said, adding the agency cannot afford to duplicate work.

FDA should organize its information like industry-sponsored drug websites, which separately target information to healthcare providers and consumers, Public Citizen Health Research Group Director Sidney Wolfe suggested.

"So the route should be the FDA homepage, to drugs, and on the drug homepage it should say 'drug information for patients' big, big, big. They go there and in one integrated place, as opposed to 10 integrated places, one could find out the latest information, and it will be identified as the latest information," Wolfe said.

Cheek advised FDA to gather consumer input regarding its website, adding: "If I were really trying to get information about drugs, I'd go somewhere else."

Currently, visitors to FDA's website are being randomly requested to complete a "Consumer Satisfaction Survey." The survey asks users about the site's ease of use, the clarity and complexity of the information presented and the features they use most.

Ellen Liversidge, a health care consumer and the mother of a son who was being treated with Lilly's Zyprexa (olanzapine) when he died of profound hyperglycemia, found FDA's website "confusing, not user friendly and very bureaucratic looking." She suggested FDA consult Health Canada's website which has a consumer product safety button near the top of the home page.

Other presenters warned FDA against relying too heavily on the internet to disseminate drug risk information, as it hinders access to special populations with limited English skills, low literacy and the elderly. "Only having access to the patient information sheets through the internet will limit the utility and effectiveness for some of the populations that need it the most," Zuckerman said.

According to research presented by Time Inc. Associate Director of Market Development Carol Rothkopf, one out of five Americans read below fifth grade level, while most health care information is written at a 10 grade level.

"Although the internet is expanding, less than one-third of seniors age 65 and over have ever gone online," Zuckerman said. "FDA should not just rely on the internet, but also use pharmacists, family care givers and healthcare professionals to convey information to seniors."

As a supplement to hand-written drug use information regularly disseminated at pharmacies, FDA should undertake a national awareness campaign to encourage consumers to visit FDA's website and download patient information sheets, National Council on Patient Information & Education Exec VP Ray Bullman said.

Bullman also recommended inserting information on appropriate use and risk of medications within the Center for Medicare & Medicaid Services' mailings to elderly beneficiaries about the Medicare drug benefit program.

"Since timing is everything, I would suggest...trying to work out [an] ongoing relationship with CMS to provide information to the Medicare population as materials are disseminated not just about enrollment, but as the program rolls on, about safe and appropriate use of the medicine," Bullman said.

Other presenters disagreed, calling CMS-issued information "unintelligible" and "unworkable."

Instead, Wolfe suggested that FDA mail simple, easy-to-read drug risk information to the elderly with their monthly Social Security checks. "There is an opportunity if you work with HHS, which sends out the Social Security checks, to get a simple piece of information included with check...which you could design," Wolfe said.

The information should be "simple, [in] clear large print, and it would go with the social security check, which everyone opens," he noted. "It's within the department but not depending on CMS."

FDA Should Have Separate Consumer Website, Panelists Say At Risk Hearing

More from Archive

More from Pink Sheet