Drug companies that think they have free reign to do what they want on the Internet had better think again.
The Liposome Company learned that the hard way. In December, the small New Jersey firm was the unlucky recipient of the first letter accusing a company of violating the Food Drug and Cosmetic Act on the Net.
The Food and Drug Administration had trouble with the way Liposome was describing a drug called Albocet on its homepage. The company changed the wording as soon as it got the letter, Liposome spokesman Brooks Boveroux said: "We responded as fast as we could. It was not major."
FDA spokesman Brad Stone agreed--as federal violations go, it was a small one. Nonetheless, the letter served notice to drug companies everywhere that the agency's watchful eye is beginning to cast a serious glance toward cyberspace.
The explosion of pharmaceutical and other health-related information on the Net has raised concerns about its reliability among legislators, consumer groups, and the medical establishment. In the absence of any concerted government oversight of the new mass medium, the FDA is taking the lead with a 59-year-old food and drug statute to regulate the new terrain.
"We're monitoring them," Stone said. "No one should see the Internet as unregulated. It's regulated in the same basic ways other media are. The same rules apply to the Internet that apply to other forms of media, and the same concepts apply."
But, he added, while the FDA's law is easily applied to some parts of the Internet--such as written information on drugs contained in home pages--it is fuzzy at best when it comes to most areas, particularly newsgroups and chat forums.
So in October, the agency held a conference with representatives from drug companies, advocacy groups, regulating bodies, and health care providers to begin discussing the issue. The FDA is using comments from the conference and letters it received through January to develop a policy aimed at regulating the Net without killing free-flowing discussion.
It won't be an easy balancing act. People have come to rely on information about health care on the Net. Many patients have formed online communities, and Netizens often visit Web sites sponsored by doctors and drug companies to get information.
The potential windfall from the Net is not lost on the pharmaceutical companies, many of which have their own sites promoting their products. But issues involving conflict of interest have arisen as some drug companies underwrite other sites, such as Searle's sponsorship of the "chronobiology" portion of doctor-run MedicineNet, a clearinghouse of medical information.
Searle has an interest in chronobiology, an emerging field that deals with with timing medication to the body's natural daily rhythms, company spokeswoman Claudia Kovitz said. But Dr. Dennis Lee, a gastrointerologist who founded MedicineNet, said the company has no editorial influence over the site.
In general, the FDA has no problem with sites that are clearly labeled and identified as drug-company sponsored. It gets a little trickier, however, as the gray areas begin to emerge.
For instance, it's difficult to say what potential liability might arise if a pharmaceutical employee, speaking as an individual to a patient or consumer, recommends a drug from his company.
But the bottom line for many who send comments to the FDA is access to information on the Internet, said Melissa Moncavage, a public health adviser for the agency.
"They don't want to have information withheld or not be able to get access to it," she said. "This is considered to be a great resource."