Friday, September 30, 2005


Deputy commissioner says Internet updates part of plan

Thursday, September 29, 2005; Posted: 11:51 a.m. EDT (15:51 GMT)


WASHINGTON (Reuters) -- Prescription drug labels will be easier to read and updated quickly on the Internet as part of an effort being launched later this year to improve information for doctors and patients, a U.S. health official said Wednesday.

Regulators have been promising a major revamp of prescribing instructions for years. Labels for physicians now run several pages and have side-effect information scattered throughout. It can take months for new warnings to be added.

Rules outlining a new format will be issued soon, said Dr. Scott Gottlieb, the Food and Drug Administration deputy commissioner for medical and scientific affairs. He declined to provide details.

"This is an important step toward creating an electronic environment for drug safety and drug effectiveness information that will make it easier for doctors and patients to get up-to-date information right at the point of care," Gottlieb told reporters.

The step is part of a broader program that will begin in November to make important information readily available by electronic means such as over the Internet or through personal digital assistants, he said.

Drug makers will have to submit changes to their product labels electronically starting next month in a standard format that makes updating older versions "seamless and automatic," Gottlieb said.

The agency also is "seriously discussing" releasing regular updates, perhaps weekly, about side effect reports for drugs on the market, he said.

Peter Lurie, deputy director of Public Citizen's Health Research Group, a consumer group, said the ideas were good ones, but noted that the FDA should approve more "medication guides" that explain risks and benefits to consumers in plain English.

"That's the simplest way to inform the patient, to provide them with FDA-regulated and approved information at the time of prescribing," he said.

The FDA has been attacked as being too slow to respond and warn the public about signs of serious side effects from some medicines. Two agency scientists went public with charges that their supervisors downplayed or suppressed their concerns about antidepressants used by children and Merck & Co. Inc.'s recalled arthritis drug Vioxx.

Gottlieb, a practicing physician, also has come under criticism since he took his current FDA post in July following a stint in the private sector, which included editing a Wall Street newsletter that offered tips on health-related stocks.

Time magazine reported some of his e-mails that raised questions about rulings on certain drugs sparked concern that he was trying to steer decisions in an industry-friendly way.

Asked about the charges, Gottlieb said Wednesday: "We are living in an environment now where it's very hard to ask scientific questions of people.

"Every time you ask questions, it's supposed you are trying to second-guess someone's judgment. That's fundamentally unfair, and I don't think the result is going to be more information and better decision-making. I think the result is going to be quite the opposite," he said.

http://www.cnn.com/2005/HEALTH/09/29/fda.drug.labels.reut/index.html