March 25, 2008
The not-for-profit iHealth Alliance, a not-for-profit group operated by the for-profit company 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 receive most notifications by regular mail.
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 participate.
Participating physicians will receive e-mails in about two months that instruct them to visit the Web site for new notifications, and the e-mails will focus on their specialties.
Physicians also will be able 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. The records could be used to alert physicians about major public health emergencies or bioterrorism threats, according to the Journal.
Background
In 2006, FDA issued a guidance that allowed pharmaceutical companies to send safety notifications by e-mail. Previous federal regulations required the notifications be sent through a paper-based system.
However, many pharmaceutical companies continue to send such notifications by regular mail to ensure that they reach doctors.
Physicians said the notifications take "too long to arrive" and are sometimes thrown out with junk mail, according to the Journal.
Participants
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.
In addition, GlaxoSmithKline likely will use the site, Alan Metz, North American medical director for the company, said. (Rubenstein, Wall Street Journal, 3/25)