2011-8218. Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia): Debarment Order

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia) for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Ms. Chatman was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Ms. Chatman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Chatman failed to respond. Ms. Chatman's failure to respond constitutes a waiver of her right to a hearing concerning this action.

DATES:

This order is effective April 7, 2011.

ADDRESSES:

Submit applications for termination of debarment to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Kenny Shade, Office of Regulatory Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds that the individual has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and if FDA finds that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.

On March 14, 2006, Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia) pleaded guilty to a misdemeanor offense of misbranding a drug. On August 14, 2006, the United States District Court for the District of Oregon entered judgment against Ms. Chatman for misdemeanor misbranding a drug, in violation of 21 U.S.C. 331(k) and 333(a)(1).

FDA's finding that debarment is appropriate is based on the misdemeanor conviction referenced herein. The factual basis for the conviction is as follows: Ms. Chatman was a registered nurse licensed by the Oregon Board of Nursing. Throughout 2004, she assisted a codefendant in operating two clinics that offered treatments they claimed could combat the effects of aging, including injection with BOTOX. From August 2004 through December 2004, Ms. Chatman offered a botulinum toxin called “Refinex” for sale for injection to patients under the name of another drug, BOTOX. Refinex is manufactured by the Shandong Bioresearch Institute in the People's Republic of China and has never been approved or licensed by FDA for any use. Ms. Chatman misbranded a drug, namely botulinum toxin type A manufactured by Shandong Bioresearch Institute and known as Refinex, while it was held for sale and after shipment in interstate commerce, in that she offered Refinex for sale by injection to patients under the name of another drug that is approved, namely BOTOX, all in violation of 21 U.S.C. 331(k) and 333(a)(1).

As a result of her conviction, on January 5, 2011, FDA sent Ms. Chatman a notice by certified mail proposing to debar her for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(b)(2)(B)(i)(I) of the FD&C Act, that Ms. Chatman was convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and that the conduct that served as a basis for the conviction undermines the process for the regulation of drugs. The proposal also offered Ms. Chatman an opportunity to request a hearing, providing her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Ms. Chatman failed to respond within the timeframe prescribed by regulation and has, therefore, waived her opportunity for a hearing and waived any contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

Therefore, the Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to him (Staff Manual Guide 1410.35), finds that Cathryn Lyn Chatman has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act, and that the type of conduct that served as a basis for the conviction undermines the process for the regulation of drugs.

As a result of the foregoing finding, Ms. Chatman is debarred for 5 years from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES), (see sections 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the FD&C Act (21 U.S.C. 321(dd)). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Ms. Chatman, in any capacity during Ms. Chatman's debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. Chatman provides services in any capacity to a person with an approved or pending drug product application during her period of debarment she will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Ms. Chatman during her period of debarment (section 306(c)(1)(B) of the FD&C Act (21 U.S.C. 335a(c)(1)(B)). Any application by Ms. Chatman for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA-2010-N-0443 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j).

Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: March 22, 2011.

Howard Sklamberg,

Director, Office of Enforcement, Office of Regulatory Affairs.