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FDA’s Risk Communication Advisory Committee has made several recommendations, said FDA Deputy Commissioner for Policy Randall Lutter in a column on the agency’s Web site. “The recommendations advise us to treat risk communication as a core activity and plan and provide resources to support it,” he said. “They advise us to take advantage of outside expertise to get the research we need so that our risk communications are grounded in scientific standards. They also advise us to develop a process to involve you – both the public and healthcare professionals - in deciding how we communicate with you.”

The agency has created an internal council charged with figuring out how to act on the recommendations, and how to make risk communication policies more consistent throughout the agency.

CDRH has proposed to stop requiring baseline reporting as part of device adverse-event reports because the information is also contained in MedWatch mandatory reporting forms.

The proposal is proceeding under a direct final rule unless an adverse public comment is received. In such a case, the proposal would move under a proposed final rule. The proposal may be accessed here.

– James G. Dickinson

CDRH has settled with a consumer group and has abandoned its position that dental mercury amalgams have every right to stay in the marketplace without a warning label.

The deal came three months after a settlement offer from Consumers for Dental Choice. The group had been trying for 10 years to get CDRH to require labels about the neurotoxic side effects of mercury amalgams.

In a news release, attorney Charles G. Brown for the group said: “During a several-hour negotiation session, FDA agreed to change its Web site on amalgam—dramatically.” He continued, “Gone, gone, gone are all of FDA’s claims that no science exists that amalgam is unsafe, or that other countries have acted for environmental reasons only, or that the 2006 scientific panel vote affirmed amalgam’s safety.”

Instead—see www.fda.gov/cdrh/consumer/amalgams.html—FDA has moved to a neutral course. Its new policy statement recognizes the serious health concerns posed by mercury amalgam, in particular for children and unborn children, pregnant women, and those with mercury immuno-sensitivity or high mercury body burdens.

Brown called the agency’s move “a 180-degree reversal from FDA’s 30-year policy of protecting mercury fillings…To change FDA policy, we tried petitions, congressional hearings, state law fact sheets, scientific advisory committee hearings, and letters galore—to no avail. So in the great American tradition, we sued.”

This led to judicial direction to mediate, and the agreement was forged May 30 before District of Columbia federal court magistrate judge John M. Facciola.

“The impact of the rewriting of [FDA’s] position on amalgam can hardly be understated,” Brown said. “FDA’s Web site will no longer be cited by the American Dental Association in public hearings. FDA shows awareness of the key issues involved. As it prepares to classify amalgam, FDA has moved to a position of neutrality. Indeed, having repeatedly raised the question of amalgam’s risk to children, young women, and immuno-sensitive persons on its Web site, I find it inconceivable that FDA will not in some way protect them in its upcoming rule.”

– James G. Dickinson

In a column on FDA’s Web site, Murray Lumpkin, MD, FDA’s deputy commissioner for international and special programs, reminds industry that one cannot extrapolate adult clinical data to make assumptions about how a medical product will work on children. Most of the column discusses drug dosages, but Lumpkin notes that legislation passed last fall expands efforts to help ensure that strong, science-based data are developed to guide the safe use of medicines in children to pediatric medical devices.

“FDA remains firmly dedicated to actively facilitating and fostering the development of sound data to guide the safest and most effective use of medicines and medical devices in our children,” he said. “Children are not little adults. They are not second-class citizens. They are not guinea pigs. They are our most precious gift. Children deserve medical care based on the best data science can give us.”

FDA on August 4 enacted a long-discussed policy that sets limits on how tied members of its advisory panels can be to the industries those panels deal with, reports TheHill.com. Experts may not participate on an advisory committee if they are a member of their immediate family have a stake of more than $50,000 in any companies who come before that panel. Those with stakes of less than $50,000 need a waiver from the agency in order to participate. The agency says it will grant a waiver only if it “determines that there is an essential need for the adviser’s particular expertise.”

Many experts recruited by FDA to serve on panels also consult for drug and device companies. This had led to criticism from some members of Congress and the public that the panels are biased in favor of industry.

The agency also implemented a rule that will make the materials for all panel meetings available to the public at least 48 hours before the meeting starts. And votes will now be conducted simultaneously, not sequentially, to prevent panelists from being influenced by the votes cast before theirs.