FDA goes digital for faster "Dear Doctor" letters

Washington -- Assuming that physicians would rather not be the last to know that a drug or a device they prescribe or use carries previously undetected dangers, the Food and Drug Administration, the AMA, physician specialty groups, drug and device manufacturers and liability insurers are promoting a new early-warning system that moves doctors ahead in the queue.

The online system, called the Health Care Notification Network, is expected to debut next month. Even before its launch, more than 100,000 physicians have signed up, said the network's developers. That number is expected to grow.

HCNN, which is free to physicians, will be funded by drug and device makers. It is designed to convey the same information that has been delivered by the U.S. Postal Service in the form of "Dear Health Care Professional" or "Dear Doctor" letters, but this time the information will be delivered more quickly via e-mail and accessible from any Internet-capable device.

The network's developers estimate that it could cut to a day or two -- from the three to four weeks it now takes -- the time needed for drug and device manufacturers to draft a letter, gain FDA approval, print and mail the communication.

The need for speed in alerting physicians to possible dangers associated with drugs and devices is being called a patient safety issue -- a matter of continuing focus as reports are released calling attention to preventable deaths or questioning prescription drug safety.

Avoiding the longer time frame also cuts the risk that patients will get the news before doctors. "Electronic warnings make sense if for no other reason than to keep yourself on the same electronic footing as patients," noted Nancy W. Dickey, MD, chair of the iHealth Alliance, a nonprofit board that governs the new service.

The alliance will ensure that e-mail addresses of registered physicians are used exclusively for safety alerts and not spam or ads, said Dr. Dickey, a former AMA president and president of the Texas A&M Health Science Center in College Station.

In addition, physicians should expect more FDA communications, she said. "Medicine will only become more complex, and we can expect that updated information from the FDA is going to increase."

Network advocates

The network also has the agency's support. "This is a great opportunity for better protection of medical products in this country," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, when the network was first announced in March. Paper alerts will continue to be sent, she said, although the hope is that they will eventually be phased out.

The AMA also supports HCNN and is encouraging physicians to enroll. "This is another route to get the message out to practicing physicians that there may be a significant change in the way medicines are used or that some problem has surfaced in the way devices are used," said Edward L. Langston, MD, then chair of the AMA Board of Trustees.

Other efforts are under way to speed risk communication between the FDA and physicians, noted Dr. Langston. One, which is being conducted by the AMA and about a dozen specialty groups, involves collecting e-mail addresses from members for use by the FDA to convey new data.

Another, MedWatch, which was established by the agency in 1993, plays a similar role. However, MedWatch has not been very popular with physicians. Critics say it inundates participants with information -- much of it irrelevant to their practices. And, despite MedWatch's 15-year life span, only about 90,000 individuals have signed up, an unknown number of whom are physicians.

Why should HCNN expect to do better? For one thing, it will target notifications to the physicians who need them, said Edward Fotsch, MD, the CEO of Medem Inc., a for-profit company founded in 1999 by the AMA and six other medical societies. Medem will operate the network.

MedWatch is a "one-size-fits-all" system, said Dr. Fotsch. The FDA program sends out "tons of stuff," he said, with the risk being that doctors may miss messages that are important to their practices. MedWatch sends one or two or even more notifications each week to all enrollees, he said.

In contrast, HCNN will disseminate the same number of alerts sent by manufacturers, but alerts will be tailored by specialty, so individual doctors will receive about one or two per month, Dr. Fotsch estimates. "For example, a recall of a pacemaker wire wouldn't go to pediatricians."

The network will provide a link to MedWatch, which retains the important function of collecting reports of adverse events. Dr. Dickey hopes that will make it easier for physicians to send a message about a patient's possible reaction to a medication. "If it were easy to click on an icon and send a message to the FDA, the quality of their pharmaceutical evaluations would go up, and we would know a great deal more about medication interactions and reactions than we do now based on minimal responses from a handful of physicians."