From: BULLELKMAN@aol.com Sent: Thursday, March 25, 2004 1:59 AM To: FDADockets@oc.fda.gov; brownchas@erols.com Cc: Fourpawsca@aol.com; sandyduffy@comcast.net; BULLELKMAN@aol.com Subject: Docket # 01N-0067 - SUPPLEMENTAL REQUEST FOR REFERRAL TO AN ADVISORY COMMITTEE To: Food and Drug Administration Dockets Management Branch (HFA-305) 5630 Fishers Lane, Room 1061 Rockville, MD 20057 Re: Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy (Docket No. 01N-0067) SUPPLEMENTAL REQUEST FOR REFERRAL TO AN ADVISORY COMMITTEE I. Background On February 20, 2002, the Food and Drug Administration ("FDA") published a proposed rule in the Federal Register entitled, "Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy" (the "Proposed Rule"), 67 FR 7620. In the Proposed Rule, the FDA announced its intent to take three actions: 1) issue a separate classification regulation for encapsulated mercury intended to be mixed in a single-use capsule to form filling material for the treatment of dental caries (a pre-amendments device that was never classified) to deem it a class II device; 2) amend the classification for amalgam alloy (a class II device) to add certain special controls; and 3) reclassify dental mercury intended for use as a component of amalgam alloy in the restoration of a dental cavity or broken tooth from (currently a class I device) to class II. See id. Specifically, FDA proposed that certain regulatory guidance and voluntary consensus standards be applied to dental amalgam, including: ingredient labeling; storage and handling instructions; specifications and test methods for determining product composition; and packaging and marketing recommendations. Id. at 7627-7628. FDA sought public comment on the Proposed Rule. As discussed below, in September 2002, Consumers for Dental Choice submitted their comments regarding the Proposed Rule. Those comments identified specific problems with the Proposed Rule, provided references to scientific information regarding the potential health risks associated with the use of dental amalgam, and formally requested that FDA convene a new, balanced advisory committee to address many of the issues raised in the Proposed Rule. II. FDA Frequently Has Used Its Authority to Seek Review of Scientific and Regulatory Issues by Outside Advisory Committees Over the years, FDA frequently has sought advice from outside experts on a wide array of topics--from BSE to product approvals to food biotechnology--using both its standing advisory committees as well as ad hoc committees created for a specific purpose. FDA currently has 32 standing advisory committees, including the Medical Devices Advisory Committee, which was established in 1990 and includes a Dental Products Panel. Outside experts often provide not only additional resources, but also scientific or other expertise, and a fresh and balanced perspective on regulatory issues that the Agency may have been dealing with for a long time. Advisory committees are an important tool that the Agency has to further examine important issues before it, and FDA has ample precedent for such use. Therefore, it is entirely appropriate for FDA to utilize an outside advisory committee for the review of the many important scientific and regulatory issues raised by the Proposed Rule, including: the classification of medical devices, the use of performance standards and controls, and the data regarding the health and safety risks that dental amalgam poses to patients. III. FDA Should Refer the Important Scientific and Regulatory Issues Raised by the Proposed Rule to An Advisory Committee On May 23, 2002, Consumers for Dental Choice requested the creation of a new Advisory Committee, the sole subject of that filing to the rule. See Exhibit A. When the time to comment was enlarged, Consumers for Dental Choice submitted more extensive comments in September 2002, including as the first request for relief (page 10) that an new Advisory Committee be empanelled. See Exhibit B. In those comments, Consumers for Dental Choice formally requested that a new advisory committee be created and that meetings be held regarding the dental amalgam issues raised in the Proposed Rule. Presumably, such an advisory committee: 1) would be designated by a charter; 2) would conduct open public meetings, 3) would have an FDA official present at each meeting; 4) would have its meeting agendas approved by a government official; 5) would have official minutes of each meeting; and 6) would make all information under consideration available to the public, to the extent that such information is releasable under the Freedom of Information Act. 5 U.S.C.A. App. 2 §§ 9, 10. To date, FDA has not convened an advisory committee to address any of the specific issues outlined in the Proposed Rule. Consumers for Dental Choice respectfully submits this supplemental request that FDA convene a new advisory committee, as provided for under 5 U.S.C.A. App. 2 § 1 et seq., to consider whether the Proposed Rule adequately addresses the potential health and safety risks associated with the use of dental amalgam, as well as the following other issues: · Whether the scientific data regarding the potential health risks associated with dental amalgam warrant a ban on the use of such products in the United States; · Whether the scientific data regarding the potential health risks associated with dental amalgam warrant stricter controls on the use of dental amalgam in certain vulnerable populations, including children and pregnant women; · Whether the special controls contemplated in the Proposed Rule, (e.g. labeling requirements, controls on storage and disposal, and standards for specifications and test methods) are sufficient to protect patients, including children and pregnant women, from the risks of dental amalgam; and · Whether there are any other, more stringent regulatory controls that FDA could require in order to better protect patients from the potential risks associated with the use of dental amalgam. As discussed in its previous comments submitted to the Agency, Consumers for Dental Choice believes that, in its current form, the Proposed Rule is deeply flawed. However, Consumers for Dental Choice supports open, public discourse from a balanced panel of experts on these important dental amalgam issues, and believes strongly that referral of these issues to a new advisory committee could provide just that. Therefore, Consumers for Dental Choice reiterates its request that the issues contained in the Proposed Rule be referred to a newly-chartered advisory committee. Submitted March 24, 2004 by: Charles G. Brown, Counsel Consumers for Dental Choice 1725 K St., N.W., Suite 511 Washington, D.C. 20006 (202) 822-6307 brownchas@erols.com cc: Mary Ann Newell, Vancouver, Washington -- Manager of Rule Docket for Consumers for Dental Choice