Prescription drug websites are under-regulated by the Food and Drug Administration and may cause confusion or mislead consumers, according to a recent study by the University of Minnesota and Dartmouth University.
Jon Schommer, associate head of the University’s department of pharmaceutical care and health systems, and Dartmouth linguistics professor Lewis Glinert, examined the websites of the 100 best-selling prescription drugs and found a surprising lack of consistency when it came to advertising standards.
Many of the websites displayed an unpredictable mix of information, promotion, content, verbal style, visuals and layout, the study found. Furthermore, safety and risk information was often presented in small font, detached from promotional content and located toward the bottom of the page.
Gary Schwitzer, publisher of Healthnewsreview.org and former professor in the University’s School of Journalism and Mass Communication, said the overflow of information from drug websites is “just crazy.”
Consumers are looking for meaningful, unbiased information on navigating an already confusing health care system, Schwitzer said.
“[The websites] are like a fire hose,” he said. “So we take this dying, thirsty person and just gush them with water and expect them to get a drink.”
One of the major problems Schwitzer said he finds with the under-regulation of prescription drug websites is in the endless ways a company can go about designing a page. It’s a science to make it easy to find information on a website, but it’s also easy to design a website where information is hidden, he said.
This sort of information overload plays a great deal into why it is hard for the FDA, which is responsible for the regulation of direct-to-consumer prescription drug websites, to keep up with the drug companies.
The advent of new media outpaced the FDA’s regulatory system, and the regulators are a step behind, Schwitzer said.
When the FDA finally catches something and wants to enforce repercussions, the drug company may have already dropped the campaign in question, he said.
While Schwitzer and the study’s leaders believe the problem lies in a lack of FDA regulation, University of Minnesota Law School professor Ralph Hall feels differently.
When it comes to regulating ads, the FDA has extensive rules on how information must be presented or left out, Hall said. The FDA also has a substantial power to regulate, he said.
“There are enforcement actions and warning letters that can be issued, and under the right circumstances, criminal action can be taken,” he said.
The real problem is the audience that prescription drug companies gear their information toward, Hall said. Since prescription drugs can be prescribed only by doctors, historically all the information provided by the companies has been written for a medically-educated audience, he said.
For example, a website might list a side-effect of a drug to be “syncope,” which means fainting, “but how many people actually know what that word means?” Hall said.
“The challenge here is trying to figure out how to take highly complex scientific information and communicate it to the layperson,” he said.
A second problem Hall sees is off-label use of a drug. The FDA approves a drug’s use, not the drug itself. This means that penicillin may be approved to treat a specific problem, but a doctor may decide to prescribe it to treat something else.
It is not illegal for that doctor to prescribe penicillin for the secondary use, Hall said.
Similarly, if that doctor posts something online describing the secondary treatment, the FDA cannot regulate what is posted.
When consumers type the name of a drug into a search engine, a doctor, hospital or patient advocacy group page may come up that includes information that is not FDA-approved, Hall said.
“We run into a challenge here, and that is called the First Amendment,” he said.
Although the FDA has substantial power to regulate, the organization has expanded its Division of Drug Marketing, Advertising and Communications, which is responsible for reviewing prescription drug websites. However, Schwitzer said he believes the solution begins with increased community education and awareness.
“We need to have a broader discussion,” he said. “We need to have a broader awareness of what is at stake.”