Not-for-Profit Group To Launch Web Site To Notify Physicians of Medication Label Changes, Warnings, Recalls
The iHealth Alliance, a not-for-profit group operated by for-profit Medem, plans to launch a Web site that will e-mail physicians to notify them of significant label changes, warnings and recalls related to medications, the Wall Street Journal reports. Currently, physicians in most cases receive such notifications by regular mail.
In 2006, FDA issued a guidance that allowed pharmaceutical companies to send such notifications by e-mail, rather than by regular mail, as previous federal regulations required. Many pharmaceutical companies have continued to send such notifications by regular mail "because it has seemed like the surest way to reach doctors," but physicians maintain that the notifications take "too long to arrive" and "often get buried in stacks of drug company marketing materials or thrown out with junk mail," according to the Journal.
Pharmaceutical companies will pay to use the Health Care Notification Network, which will not include any marketing materials from the companies and will provide access at no cost for physicians who decide to participate. Physicians who decide to participate will receive e-mails that instruct them to visit the Web site for new notifications, with the e-mails focusing on the specialties of the physicians. The Web site will begin to send such e-mails in about two months.
After physicians visit the Web site, they will have the ability to send comments to FDA and pharmaceutical companies about patient reactions to medications. The Web site will record which physicians have viewed the notifications and will archive the notifications for one year. According to the Journal, the Web site also could "be used to send doctors information on major public health emergencies or bioterrorism alerts."
Medem officials said that five large pharmaceutical companies have requested contracts to use the Web site, although they have not finalized any agreements. Johnson & Johnson officials have said that the company will use the Web site, and Alan Metz, North American medical director for GlaxoSmithKline, has said that the company likely will use the site (Rubenstein, Wall Street Journal, 3/25).
