An FDA Seal of Approval for Online Information? - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

An FDA Seal of Approval for Online Information?
With so many healthcare and pharmacy websites, consumers could use the agency's nod of support.


Pharmaceutical Technology
Volume 33, Issue 12, pp. 12


Michelle Hoffman
Knowledge is power, so the saying goes. And so the Internet must be the most empowering tool of all. But is all knowledge equally empowering in all hands under all conditions? More specifically, when it comes to medical and pharmaceutical knowledge, are people really better off having access to the bounty of medical and pharmaceutical sites?

The US Food and Drug Administration seems to be wondering just that. In mid-November, it held a public hearing on "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." The purpose of the hearing, according to an agency announcement, is to help guide FDA "in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools."

The transcript of this hearing will not be available until sometime in December, so I do not know what FDA is proposing. But the Pharmaceutical Research and Manufacturers of America (PhRMA), welcomed the initiative, calling the hearing a "new and exciting step toward ensuring that patients can easily access truthful and reliable information about medical products online," according to a published transcript of a press briefing held by the trade organization in advance of the FDA hearing. In the transcript, Jeffrey Francer, PhRMA's assistant general counsel, offers PhRMA's suggestion that FDA develop a "single, universal symbol that would, in a single click, take users directly to pages displaying FDA-regulated prescribing information as well as patient medication guides." Such a symbol, he suggests would serve as an "unambiguous sign that an ad or Web site contains reliable information about medicine that is regulated by the government."

In what seems to be a related initiative, FDA announced a collaboration with the website EverydayHealth.com, onto which FDA will deliver consumer health information. The goal, said FDA Commissioner Margaret Hamburg in a Nov. 17 agency press release, is to "reach millions more consumers with accurate, science-based information that can help them make decisions about their health."

In another era, these initiatives would seem like an uncomfortable incursion of government into the press. But I think there's a case to be made for this initiative.

The first thing to consider is that the Internet offers information, which is not at all the same as knowledge. Yet, some people could easily confuse the two, especially if they thought the medical information sites they visit are legitimate sources of health information.

In the old days—that is, before the Internet—that function was largely the job of physicians and other professional healthcare providers. But the Internet can cut out that middleman, leaving many information-seekers to decide for themselves which sites offer reliable information. Of course, health-related information has always been available in newspapers, on TV, and in magazines. While many health communicators in these venues were not specialists, they almost always consulted people who were. Furthermore, people still relied on professional healthcare providers to prescribe drugs. But that's not the case today. Internet users now have the means to take their therapeutic regimen into their own hands.

Patients now have direct access to prescription drugs through online pharmacies, many of which don't require prescriptions. So, it's possible for someone to diagnose and treat themselves. And there's a good chance that drugs purchased over the Internet are adulterated, counterfeit, contaminated, expired, or all of the above. In her Oct. 2, 2009 blog post, Assistant Editor Alexis Pellek cited a study (see blog.PharmTech.com) in which only four of the 2930 online pharmacies investigated carried the Verified Internet Pharmacy Practice Sites (VIPPS) certification. (The VIPPS program is governed by the National Association of Boards of Pharmacy. FDA advises consumers to confirm VIPPS certification of online pharmacies.)

By eliminating the middleman of a professional healthcare provider, the Internet may have, in fact, created a credibility vacuum. The health and well-being of many people may benefit if someone filled that vacuum, and FDA may be the right agency to do it.

Michelle Hoffman is editor-in-chief of Pharmaceutical Technology. Send your thoughts and story ideas to

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here