Reproduced with permission from Medical Devices Law & Industry Report, Vol. 1, No. 10 (July 4, 2007) pp. 258-259. Copyright 2007 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com
FDA Mulling Changes to Dental Amalgam Policy, May Issue Proposed Rulemaking
The Food and Drug Administration is considering preparing a proposed rule to classify a commonly used dental filling containing mercury, an agency spokeswoman told BNA June 25.
FDA intends to issue an Advanced Notice of Proposed Rule Making (ANPRM) to solicit public comments regarding the classification of dental amalgam, the "silver fillings" used by many dentists to fill in cavities, agency spokeswoman Kris Mejia said.
Mejia was unable to provide specific details on the content of the notice or the date is will be issued. However, Charlie Brown, an attorney with Consumers for Dental Choice in Washington, told BNA June 27 that he expects the agency to take action by the end of July.
'Dramatic' Decision. The decision to issue the ANPRM follows an April 13 ruling from the U.S. Court of Appeals for the District of Columbia Circuit, in which the court rejected a bid by several consumer groups seeking to force the agency to classify the fillings under provisions of Federal Food, Drug, and Cosmetic Act (1 MELR 134, 4/25/07).
The consumer groups argued that mercury in dental fillings causes physical harm to dental employees who handle the material and to patients who inhale the mercury vapors emanating from the fillings in their mouths.
The court of appeals said it lacked the statutory authority to order the agency to act, but attorneys for the consumer groups continued to meet with FDA officials to persuade them to change the agency's policy on silver fillings.
Brown, who represented the petitioners, called the FDA's decision "equal parts dramatic, disappointing, and enigmatic."
The dramatic, according to Brown, is that the agency is withdrawing its previous policy of allowing anyone to receive these fillings without any warning. "We commend FDA for belatedly starting down this path," said Brown.
Nonetheless, Brown said he was disappointed because "FDA is not going to do anything now—no warnings for pregnant women or children," and no requirement to disclose to consumers that silver fillings contain as much as 50 percent mercury.
And the question remains of what FDA will do in the new regulation, Brown said. But, he added, the agency's decision to change its current policy" suggests FDA will end up with a quite different agenda."
Panel Recommends Changes. Silver fillings are made of approximately 50 percent liquid mercury that is mixed with a powder containing silver, tin, copper, zinc and other metals, according to FDA's Web site on dental amalgam (http://www.fda.gov/cdrh/consumer/amalgams.html). Mercury vapor is released when the amalgam fillings are placed in, or removed from, a patient's teeth and also during chewing, according to the site.
FDA opened a public docket in 2006 to collect comments about dental amalgam fillings; the docket closed Nov. 9, 2006. In September 2006, the agency also held a joint meeting of the FDA Center for Devices and Radi logical Health (CDRH) Dental Products Panel and the Center for Drug Evaluation and Research (CDER) Peripheral and Central Nervous System Drugs Advisory Committee.
The joint committee recommended that the agency consider using informed consent for patients receiving dental amalgam, and consider labeling changes restricting its use in pregnant woman and children. However, the joint panel cautioned FDA not to make any rash decisions by having the public remove their amalgams "because it appears that this problem may affect only a small segment of the population."
Brown: Lawsuit Helped Prompt Change. On April 27, 2006, Moms Against Mercury (Moms), a North Carolina nonprofit group that seeks to inform the public about the potential neurological harms of mercury exposure, filed a petition with the U.S. Court of Appeals for the District of Columbia Circuit to stop what it called the unclassified sale of the silver fillings.
Moms, joined by three other advocacy groups and five individuals, asked the court to remove the silver fillings from the market "until FDA chooses to complete its regulatory duties."
Although the appellate court said it could not order the FDA to act, Brown believes the groups' actions helped to prompt the agency to change its policy. "We believe that our petitions and lawsuits and the very movement to ban these filings has brought this issue to the attention of officials and attorneys at the top of the agency," he said.
"Things changed very fast after the court opinion," Brown added. In its brief to the appellate court, the agency admitted five times that it does not know if mercury fillings are safe, he said. After the court ruling, Brown continued to send letters to FDA and the agency agreed to have a meeting, Brown said.
"I think they recognize they need to act," Brown said. "We expect to see this [ANPRM] on the table in July," Brown told BNA. If the agency does not issue the notice "expeditiously," however, Brown said he would write the agency again and, if necessary, go back to court.
"This rulemaking will be one of the most important actions in FDA's 100-year history," he said. "Mercury is a severe neurotoxin . . . and mercury exposure can permanently damage the developing brain of a child or fetus," he added. "If FDA looks at the science . . . there is no doubt they will stop the use of mercury filings for everyone, or at least for children and women of childbearing age."
By Terence Hyland