FDA Goals: Agency hopes to streamline risk communication, device review

December 1, 2006

National report - The Food and Drug Administration's plans for 2007 and beyond include greater attention to postmarket risks and more timely reviews of medical devices, including those used for plastic and reconstructive surgery, spokesmen say.

Meanwhile, some dermatologists say the agency's apparently increasing conservatism makes their jobs tougher; however, they support the FDA's commitment to patient safety.

Improving drug safety

In November, the FDA also announced plans to strengthen its postmarket program for medical devices.

"Across the device community, we are looking at ways of improving our surveillance for safety concerns after we approve devices," says Stephen Rhodes, FDA branch chief, plastic and reconstructive surgery devices.

At public panel meetings regarding novel product applications, he says, "We're going to start including results and discussion about some ongoing post-approval studies so the panel can see how those products are doing."

Regarding device approvals, Mr. Rhodes says that for 2007, "We are trying to speed up our review process" while maintaining high safety standards.

'Nightmare' for doctors

Sources say that often, the fiercest debate about dermatologic drugs and devices occurs after approval. Nowhere is this more evident than in the iPLEDGE isotretinoin risk management program.

"iPLEDGE is a nightmare for doctors," says Michael H. Gold, M.D., medical director at Gold Skin Care Center, Advanced Aesthetics Medi Spa, The Laser and Rejuvenation Center, and the Tennessee Clinical Research Center, and clinical assistant professor, division of dermatology, Vanderbilt University School of Medicine.

"Dermatologists had a lot of anxiety about iPLEDGE before it came online. And certainly at its outset, there were a lot of logistical problems," says Jeffrey M. Weinberg, M.D., assistant clinical professor of dermatology, Columbia University.

But since the program has been online about a year, Dr. Weinberg says, "It's working fairly smoothly," though most dermatologists believe it's unwarranted.

As a practicing dermatologist, Dr. Walker says, "I fully understand the impact of this program." However, she says, "It's important that we manage the teratogenicity associated with isotretinoin, moving forward with its sponsors and the extremely valuable input we've had from the AAD (American Academy of Dermatology). Hopefully we can work together to ensure that we have a good risk management program and access to the drug" for patients who need it.