05-22884. Request for Comment on the Status of Pyridoxamine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of opportunity to comment.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that comments related to the status of pyridoxamine may be submitted until December 19, 2005. FDA is requesting comments in response to the submission of a citizen petition requesting, among other things, that the agency determine the status of pyridoxamine. All comments postmarked on or before December 19, 2005 will be accepted as part of the official record for this matter.

DATES:

Submit written comments by December 19, 2005.

ADDRESSES:

Submit written comments on the status of pyridoxamine to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments.

FOR FURTHER INFORMATION CONTACT:

Robert Moore, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1441.

SUPPLEMENTARY INFORMATION:

On July 29, 2005, FDA received a citizen petition submitted, under 21 CFR 10.30, by the law firm Morgan Lewis & Bockius, LLP, on behalf of BioStratum, Inc. The petition requests that the agency: (1) State in writing that dietary supplements that contain pyridoxamine are adulterated under the Federal Food, Drug, and Cosmetic Act; (2) exercise its enforcement authority under the act to remove from interstate commerce dietary supplements containing pyridoxamine; and (3) not place this citizen petition in the agency's docket for premarket notifications for new dietary ingredients (Docket No. 2004N-0454).

In its citizen petition, BioStratum, Inc., states, among other things, that it is the manufacturer of Pyridorin (pyridoxamine dihydrochloride), which is the subject of an investigational new drug application (IND) that was filed with FDA in July 1999 for use as a potential therapeutic agent to slow or prevent the progression of diabetic nephropathy in patients with type 1 and type 2 diabetes. The petition further states that substantial clinical trials have been conducted for this drug and that the existence of those studies has been made public. In addition, the petition states that pyridoxamine was not marketed as a dietary supplement or as a food prior to Pyridorin's authorization for investigation as a new drug under an IND.

FDA has considered the information and legal argument set forth in the petition. Based on the facts set forth in the petition, the agency tentatively concludes that pyridoxamine, the active moiety^[1] of pyridoxamine dihydrochloride, is excluded from the dietary supplement definition under the exclusion clause in 21 U.S.C. 321(ff)(3)(B)(ii) and therefore may not be marketed as or in a dietary supplement. However, although the petition asserts that there is no evidence that pyridoxamine was marketed as a dietary ingredient or as a food prior to the authorization of Pyridorin for investigation under an IND, the agency is interested in receiving information, if any, that bears on pyridoxamine's prior marketing as a dietary ingredient or as a food, as well as other information that would inform the agency's final decision on the status of pyridoxamine.

In order to afford all interested parties adequate opportunity to participate in this matter, the agency requests comments and supporting information related to this matter. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.

Dated: November 10, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

Footnotes

1.  Under 21 CFR 316.3(b)(2), “active moiety” means the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.