Federal Government

Reproduced with permission from Medical Devices Law & Industry Report, Vol. 1, No. 5 (April 25, 2007) pp. 134-135. Copyright 2007 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com

BNA Medical Devices Law and Industry Report: Group Loses Court Bid to Force FDA To Classify Dental Filling Containing Mercury

A federal appeals court April 13 said it did not have the statutory authority to order the Food and Drug Administration to classify a commonly used dental filling containing mercury under the Federal Food, Drug, and Cosmetic Act (Moms Against Mercury v. Food and Drug Administration, D.C. Cir., No. 06–1147, 4/13/07).

Moms Against Mercury (Moms), a North Carolina nonprofit group that seeks to inform the public about the potential neurological harms of mercury exposure, filed the petition April 27, 2006, to stop what it called the unclassified sale of ‘‘silver" fillings, a compound tooth filling made of approximately 50 percent mercury and an amalgam alloy composed of silver and other metals.

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.’’ They 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.

But Judge David B. Sentelle, writing for a three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit, said the appellate court lacked subject matter jurisdiction under the FDCA (21 U.S.C. Sections 301–399) to review FDA’s ‘‘regulatory inaction.’’ While the statute permits persons who are adversely affected by certain FDA actions to seek review in the court of appeals, Sentelle said, ‘‘FDA’s failure to classify a device does not directly give rise to judicial review in this Court under the FDCA.’’

The three-judge panel did not shut the door on petitioners completely, however, adding that they may have a remedy in lower court. ‘‘If judicial review of an FDA action or inaction is not provided for in the Act [at issue], challenges to such actions may be brought only in the district court,’’ Sentelle said.

Attorney: FDA Paid ‘Huge Price.’ Charlie Brown, the Washington attorney who represented the petitioners, said, ‘‘It was a challenge to get jurisdiction, we knew that.’’ But, he added, ‘‘FDA paid a huge price’’ in making its case to the appellate court.

In its brief to the court, the agency admitted five times that it does not know if mercury fillings are safe, Brown told BNA April 16. FDA officials now have admitted that they do not know if the fillings are safe, but their policy allows anyone to receive these fillings without any warning, he said.

Brown said the petitioners plan to wait one month to see if the agency changes its policy; otherwise ‘‘we’ll have to go back to court.’’

FDA spokeswoman Heidi Rebello said the agency does not comment on legal matters. However, she told BNA that the agency is reviewing public comments submitted last year about dental amalgams, but could not say what policy changes, if any, the agency might pursue. According to the FDA Web site, the agency is reviewing peer reviewed literature as well as the findings and recommendations from a September 2006 panel meeting.

FDA officials now have admitted that they do not know if the fillings are safe, but their policy allows anyone to receive these fillings without any warning, an attorney for the petitioners says.

FDA Inaction. According to Sentelle, under the FDCA, as amended by the Medical Device Amendments of 1976, all devices that were not on the market in 1976 are automatically classified as class III devices, subject to strict pre-market approval requirements, unless FDA determines that they are ‘‘substantially equivalent’’ to class I or class II devices that were already on the market at the time (pre-amendment devices). Devices that predated the FDCA amendments, like the silver fillings, were left to the FDA to classify under specific procedures.

Moms and the other petitioners argued that FDA’s decision not to classify the fillings, despite uncertainties about the safety of mercury, violates the FDCA. They argued that the agency’s failure to classify the silver fillings in the thirty years since the FDCA was amended, constitutes a final decision not to classify the compound and is thus a reviewable decision.

The petitioners also claimed that the agency improperly allowed the marketing of new mercury amalgam products by concluding they were ‘‘substantially equivalent’’ to a non-mercury powder alloy, a Class II, pre-amendment component of the compound product that is mixed with mercury to form the silver fillings.

However, Sentelle said the jurisdictional provisions of the FDCA relied upon by the petitioners apply only to agency decisions regarding premarket approval of devices, the reclassification of a device from one class to another, or to determinations of substantial equivalence, ‘‘none of which has occurred here.’’

‘‘FDA has not promulgated any regulations relating to pre-market approval of [the filling compound], nor has it issued any order relating to such application,’’ Sentelle said. In addition, the silver filling could not be the subject of any order deeming it substantially equivalent to a ‘‘pre-amendment’’ device, Sentelle explained, because the compound mixture also predates the 1976 amendments.

Brown said the court’s language suggests an ongoing violation of the law. ‘‘The court holds that FDA may not approve mercury amalgam by using a ‘substantial equivalent’ test. But that is exactly what FDA is doing when it approves mercury amalgam applications,’’ he said.

Letter to FDA. FDA needs to get this product off the market now for pregnant women and children, Brown said.

Several states, including California, Maine, Connecticut, and New Hampshire, already require dentists to post ‘‘fact sheets’’ about silver fillings in their office or to hand out information to their patients, Brown said.

On April 19, Brown sent a letter to FDA Commissioner Andrew von Eschenbach, FDA Chief Counsel Sheldon T. Bradshaw, and FDA Deputy Commissioner for Policy Randall W. Lutter, asking the agency to ‘‘remove mercury amalgam from the marketplace now’’ and to ban the use of the product for children and pregnant women. Brown sent the letter on behalf of Consumers for Dental Choice, a consumer advocacy group based in Washington.

In the letter, Brown called ‘‘outrageous’’ the agency’s ‘‘position of admitting to the Court that the science [on the use of silver fillings] is in equipoise while continuing its policy of untrammeled use of mercury fillings, without warning, for pregnant women and children.’’

Amy Carson, co-founder of Moms, and the mother of a child who suffers from the effects of mercury toxicity, said government agencies are designed to protect the public from dangerous products.

Dentists should tell their patients that the material they are putting in your mouth is a dangerous product, she told BNA. ‘‘Some would argue that the fillings are not toxic. But then, why is it when you remove the fillings they have to be disposed of’’ as a toxic substance, she asked. ‘‘Why is it toxic outside the body but not inside?’’

Brown argued the case on behalf of the petitioners. Catherine Y. Hancock, for the U.S. Department of Justice, argued the cause for FDA.

Full text of the decision is available at http://op.bna.com/hl.nsf/r?Open=thyd-728qv2 on the Web.

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