80 FR 12007 - John D. Noonan; Denial of Hearing; Final Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 43 (March 5, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 43 (March 5, 2015)
| Page Range | 12007-12010 | |
| FR Document | 2015-05042 |
[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)] [Notices] [Pages 12007-12010] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05042] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0300] John D. Noonan; Denial of Hearing; Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Dr. John D. Noonan (Dr. Noonan), and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr. Noonan for 2 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Noonan 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. In determining the appropriateness and period of Dr. Noonan's debarment, FDA has considered the relevant factors listed in the FD&C Act. Dr. Noonan has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action. DATES: The order is effective March 5, 2015. 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: Nathan Doty, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8556. SUPPLEMENTARY INFORMATION: I. Background On August 11, 2009, in the U.S. District Court for the Northern District [[Page 12008]] of New York, Dr. Noonan, a physician, pled guilty to a misdemeanor under the FD&C Act, namely misbranding a drug in violation of sections 301(k), 502(i)(3) and 303(a)(1) of the FD&C Act (21 U.S.C. 331(k), 352(i)(3), 333(a)(1)) and 18 U.S.C. 2. The basis for this conviction was conduct surrounding his injection of patients seeking treatment with BOTOX/BOTOX Cosmetic (BOTOX) with a product, TRI-toxin, distributed by Toxin Research International, Inc. BOTOX is a biological product derived from Botulinum Toxin Type A that is manufactured by Allergan, Inc., and was approved by FDA for use on humans for the treatment of facial wrinkles in 1991. According to the records of the criminal proceedings, Dr. Noonan's colleague in the same medical practice, The Plastic Surgery Group (TPSG), directed a nurse to obtain 31 vials of TRI-toxin, an unapproved drug product, which was represented by its distributor as ``Botulinum Toxin Type A.'' Dr. Noonan then proceeded to inject approximately 10 patients, who believed they were being injected with BOTOX, with TRI-toxin as a substitute. Dr. Noonan is subject to debarment based on a finding, under section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)): (1) That he was convicted of a misdemeanor under Federal law relating to the regulation of a drug product under the FD&C Act and (2) that the type of conduct underlying the conviction undermines the process for the regulation of drugs. By notice to Dr. Noonan dated November 30, 2010, FDA's Office of Regulatory Affairs (ORA) proposed to debar him for 4 years from providing services in any capacity to a person having an approved or pending drug product application. In a letter dated December 30, 2010, through counsel, Dr. Noonan requested a hearing on the proposal. In his request for a hearing, Dr. Noonan acknowledges his conviction under Federal law, as alleged by FDA. By letter dated January 28, 2011, Dr. Noonan submitted materials and arguments in support of his request. Dr. Noonan acknowledges that he was convicted of a Federal misdemeanor, as found in the proposal to debar, but argues that he should not be debarred for reasons related to the factual basis set forth in the proposal to debar. In particular, with respect to the considerations for determining the appropriateness and period of debarment under section 306(c)(3) of the FD&C Act, he argues that there are genuine and substantial issues of fact for resolution at a hearing, namely factual issues bearing on whether he participated in or even knew of certain conduct that resulted in his violation of the FD&C Act. Hearings are granted only if there is a genuine and substantial issue of fact. Hearings will not be granted on issues of policy or law, on mere allegations, denials, or general descriptions of positions and contentions, or on data and information insufficient to justify the factual determination urged or the action requested (see 21 CFR 12.24(b)). The Chief Scientist has considered Dr. Noonan's arguments, as well as the proposal to debar itself, and concludes that, although Dr. Noonan has failed to raise a genuine and substantial issue of fact requiring a hearing, the appropriate period of debarment is 2 years. II. Arguments In support of his hearing request, Dr. Noonan first asserts that he is not subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act. He contends that he pled guilty to a misdemeanor violation of the FD&C Act (see section 303(a)(1)), which is a strict liability offense, and that thus there was no demonstration or admission of criminal intent or knowledge underlying the conviction. Dr. Noonan concludes, therefore, that the conduct underlying his conviction did not undermine the process for the regulation of drugs. Section 306(b)(2)(B)(i)(I) of the FD&C Act specifically provides for the debarment of individuals convicted of Federal misdemeanors related to the regulation of drug products under the FD&C Act. Given that misdemeanor violations of the FD&C Act themselves are strict liability offenses, it stands to reason that criminal intent is not a critical component to debar an individual under section 306(b)(2)(B)(i)(I). During his criminal proceedings, Dr. Noonan pled guilty to misbranding and causing the misbranding of a drug in violation of sections 301(k), 502(i)(3) and 303(a)(1) of the FD&C Act by offering an unapproved drug, TRI-toxin, for sale as an approved drug product, BOTOX. Dr. Noonan's conduct undermined the process for the regulation of drugs in that it permitted an unapproved drug to be substituted for an approved drug without the knowledge of the patient. As a result, Dr. Noonan is, in fact, subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act. Dr. Noonan next challenges the manner in which ORA applied the considerations under section 306(c)(3) of the FD&C Act in determining the appropriateness and period of his debarment. In the proposal to debar Dr. Noonan, ORA stated that there are four applicable considerations under section 306(c)(3) of the FD&C Act: (1) The nature and seriousness of his offense under section 306(c)(3)(A); (2) the nature and extent of management participation in the offense under section 306(c)(3)(B); (3) the nature and extent of voluntary steps taken to mitigate the impact on the public under section 306(c)(3)(C); and (4) prior convictions involving matters within the jurisdiction of FDA under section 306(c)(3)(F). ORA found with respect to Dr. Noonan that the first two considerations weigh in favor of debarment and noted that the third and fourth considerations would be treated as favorable factors for him. In making all of its findings under section 306(c)(3) of the FD&C Act, ORA characterized Dr. Noonan's conduct based on records from his criminal proceedings. Under section 306(c)(3)(A) of the FD&C Act, in determining the appropriateness and period of debarment, FDA considers ``the nature and seriousness of the offense involved.'' In the proposal to debar, ORA relied on the criminal information to which Dr. Noonan pled guilty to find that the conduct underlying his convictions: created a risk of injury to consumers due to the use of an unapproved drug, undermined [FDA's] oversight of an approved drug product by representing that [he] used the approved drug while actually substituting an unapproved drug in its place, and seriously undermined the integrity of [FDA's] regulation of drug products. Under section 306(c)(3)(B) of the FD&C Act, ORA also considered the ``nature and extent of [Dr. Noonan's] management participation in the offense'' and specifically found that he was a corporate principal who ``pleaded guilty to misbranding TRI-toxin'' and ``participated in the [TPSG's] unlawful conduct of administering [an] unapproved drug on multiple occasions to patients.'' ORA concluded, therefore, that the nature and seriousness of Noonan's offenses and the nature and extent of management participation were unfavorable factors with respect to him. Dr. Noonan counters ORA's findings with respect to those two considerations in section 306(c)(3) of the FD&C Act with the following arguments: (1) That he did not admit any criminal intent or intentional wrongdoing when he pled guilty to a misdemeanor offense under the FD&C Act; (2) that, in fact, another physician at TPSG took unilateral action in ordering the TRI-toxin and directing a nurse to substitute it for BOTOX; (3) that the TRI-toxin vials that they used for injecting patients with TRI-toxin [[Page 12009]] were identical to the vials he used for BOTOX before the substitution; and (4) that since the conviction for the underlying misdemeanor was of an individual, that there was no management participation and that, thus, the nature and extent of management participation is inapplicable as a factor in determining appropriateness and period of debarment. Dr. Noonan concedes that he pled guilty to the misdemeanor offense because he was, in fact, guilty of offering TRI-toxin for sale to their patients as BOTOX. He argues, however, that the criminal records do not establish any intent or knowledge on his part and that thus the conduct underlying his conviction does not warrant debarment in light of the considerations in section 306(c)(3) of the FD&C Act. As noted previously, ORA relied on the records of Dr. Noonan's criminal proceedings for its findings in the proposal to debar. There is nothing definitive in the criminal records before FDA to contradict Dr. Noonan's assertions with respect to the nature of his involvement in the misdemeanor offense to which he pled guilty. The criminal information to which Dr. Noonan pled guilty alleges that TPSG, as opposed to Dr. Noonan, began ordering TRI-toxin for use in the medical practice, and there are no allegations that Dr. Noonan took part in the ordering process. Indeed, the proposal to debar states that, as claimed by Dr. Noonan, another physician in the practice, William F. DeLuca, Jr., was responsible for authorizing a nurse to substitute TRI-toxin for BOTOX, not Dr. Noonan. At Dr. Noonan's sentencing hearing, at which six other codefendants, including DeLuca, were also sentenced, the presiding judge also made clear that he believed DeLuca was the physician responsible for making the ``mistake'' that led to the other physician's offenses. In addressing DeLuca, the court stated: And we're here because of your actions and inactions. As I said, your mistakes were different in kind and degree from those of your colleagues. It was you who brought this drug into the practice, and it was your conduct and your failure to check out either the company or the drug that you were ordering, as you should have done, your negligence in doing that that has brought us here today in the end. In addressing Dr. Noonan, the court further stated: ``There have been disputes on how in the past over who knew what and at what point in time. It is clear from the facts in this case that you had no knowledge that the substance was anything other than [BOTOX] until your discovery of it in November of 2004.'' In short, consistent with the proposal to debar Dr. Noonan for 4 years, the records of his criminal proceedings establish that the misdemeanor convictions for the physicians in TPSG other than DeLuca were not based on any affirmative involvement in ordering the TRI-toxin or substituting the TRI-toxin for BOTOX. Furthermore, in proposing to debar Dr. Noonan for 4 years, ORA did not rely on any findings with respect to Dr. Noonan's intent or knowledge. Rather, citing the records of Dr. Noonan's criminal proceedings, the proposal to debar simply rests on Dr. Noonan's position of authority within TPSG and his conduct in misbranding TRI-toxin by administering it to patients who believed they were receiving BOTOX. As a result, under Sec. 12.24(b), there is no genuine and substantial issue of fact raised by Dr. Noonan's arguments for resolution at a hearing. As set forth in the proposal to debar and summarized previously, Dr. Noonan pled guilty to a misdemeanor under the FD&C Act for his role in offering a drug under the name of another. Based on the undisputed record before the Agency, the consideration in section 306(c)(3)(A) of the FD&C Act with respect to the nature and seriousness of the offense involved is a favorable factor. As reflected in the records of the criminal proceedings, Dr. Noonan's offense did not rest on any intent or knowledge of wrongdoing on his part, nor may such intent or knowledge be inferred from the circumstances of his offense or the findings in the proposal to debar. Although, as a practicing physician, Dr. Noonan should be expected to take the appropriate steps to avoid administering an unapproved new drug to patients or misrepresenting the drug being administered, his failure to do so over a 10-month period does not warrant considering the nature and seriousness of his offense as an unfavorable factor, relative to the range of conduct that might underlie a Federal misdemeanor conviction. On the other hand, because of Dr. Noonan's position of authority within TPSG and, thus, presumed ability to prevent the series of events that resulted in the offense underlying his misdemeanor conviction, the nature and extent of management participation in the offense is an unfavorable factor, for the purposes of the consideration under 306(c)(3)(B) of the FD&C Act. Dr. Noonan asserts that there was no management participation, and that, thus, this factor is inapplicable because the underlying conviction was of an individual. However, the criminal information to which Dr. Noonan pled guilty alleges that TPSG began ordering TRI-toxin for use in the medical practice. It is undisputed that Dr. Noonan is a principal in TPSG, and this is the basis for considering the nature and extent of management participation as a factor in determining the appropriateness and period of debarment. FDA has relied on this factor in other debarment cases where the underlying conviction was of an individual (see 78 FR 68455 (November 14, 2013), 77 FR 27236 (May 9, 2012)). The limited scope of his direct actions in committing the underlying misdemeanor offense does not mitigate the extent of his management participation, as established during his criminal proceedings and as set out in the proposal to debar. It is true that nothing in the criminal proceedings or the proposal to debar reflects any involvement by him in the decision to order the TRI-toxin and substitute it for BOTOX, and the proposal to debar specifically finds that another physician authorized a nurse to place that order. However, Dr. Noonan, as a principal of TPSG, was responsible for failing to ensure that there were controls and procedures in place to prevent other physicians or a nurse from ordering unapproved drugs for administration to patients. His own admitted inaction on that front warrants treating his management participation as an unfavorable factor.\1\ --------------------------------------------------------------------------- \1\ See United States v. Park, 421 U.S. 658, 673-74 (1975) (holding that a high-level manager within a business entity bears a responsibility to prevent and correct violations of the FD&C Act). --------------------------------------------------------------------------- Consistent with the proposal to debar, the record establishes that the medical practice of which Dr. Noonan was a part ultimately took voluntary steps to mitigate the effect on the public health from its unlawful conduct (see section 306(c)(3)(C) of the FD&C Act). Furthermore, it is undisputed that Dr. Noonan had no previous criminal convictions related to matters within the jurisdiction of FDA (see section 306(c)(3)(F) of the FD&C Act). Therefore, these will be treated as favorable factors. In light of the foregoing four considerations, one of which weighs against Dr. Noonan, debarment for 2 years is appropriate. III. Findings and Order Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of the FD&C Act and under authority delegated to him, finds that Dr. Noonan has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug [[Page 12010]] product or otherwise relating to the regulation of a drug product under the FD&C Act and that the conduct underlying the conviction undermines the regulation of drugs. FDA has considered the relevant factors listed in section 306(c)(3) of the FD&C Act and determined that a debarment of 2 years is appropriate. As a result of the foregoing findings, Dr. Noonan is debarred for 2 years from providing services in any capacity to a person with an approved or pending drug product application under section 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 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C. 321(dd)). Any person with an approved, or pending, drug product application, who knowingly uses the services of Dr. Noonan, in any capacity during his period of debarment, will be subject to civil money penalties. If Dr. Noonan, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application he will be subject to civil money penalties. In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Noonan during his period of debarment. Any application by Dr. Noonan for termination of debarment under section 306(d) of the FD&C Act should be identified with Docket No. FDA-2010-N-0300 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. Persons with access to the Internet may obtain documents in the Docket at http://www.regulations.gov/. Dated: February 24, 2015. Stephen Ostroff, Director, Office of the Chief Scientist. [FR Doc. 2015-05042 Filed 3-4-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 12007
(1) Family Violence Prevention and manner that avoids prohibited discrimination Signature of AOR:
Services Act (FVPSA) grant funds will be on the basis of age, disability, sex, race, color, [End of full FOA]
used to provide shelter, supportive services, national origin, or, as appropriate, religion.
or prevention services to adult and youth (11) Funds made available under the Authority: The statutory authority for this
victims of family violence, domestic FVPSA will be used to supplement and not program is 42 U.S.C. 10401–10414.
violence, or dating violence, and their supplant other federal, state, Tribal and local
Mary M. Wayland,
dependents (§ 10408(b)(1)). public funds expended to provide services
(2) Not less than 70 percent of the funds and activities that promote the objectives of Senior Grants Policy Specialist, Division of
distributed shall be for the primary purpose the FVPSA (§ 10406(c)(6)). Grants Policy, Office of Administration.
of providing immediate shelter and (12) Receipt of supportive services under [FR Doc. 2015–05010 Filed 3–4–15; 8:45 am]
supportive services as defined in § 10402(9) the FVPSA will be voluntary. No condition BILLING CODE 4184–32–P
and (12) to adult and youth victims of family will be applied for the receipt of emergency
violence, domestic violence, or dating shelter (§ 10408(d)(2)).
violence as defined in §§ 10402(2), (3), and (13) The Tribe has a law or procedure to DEPARTMENT OF HEALTH AND
(4), and their dependents (§ 10408(b)(2)). bar an abuser from a shared household or a HUMAN SERVICES
(3) Not less than 25 percent of the funds household of the abused person, which may
distributed shall be for the purpose of include eviction laws or procedures, where Food and Drug Administration
providing supportive services and prevention appropriate (§ 10407(a)(2)(H)).
services as described in § 10408(b)(1)(B) lllllllllllllllllllll [Docket No. FDA–2010–N–0300]
through (H), to victims of family violence,
domestic violence, or dating violence, and Tribally Designated Official John D. Noonan; Denial of Hearing;
their dependents (§ 10408(b)(2)). lllllllllllllllllllll Final Debarment Order
(4) Grant funds will not be used as direct Tribe or Tribal Organization
payment to any victim of family violence, AGENCY: Food and Drug Administration,
domestic violence, or dating violence, or to Appendix B HHS.
any dependent of such victim (§ 10408(d)(1)). LGBTQ (also known as ‘‘Two-Spirited’’) ACTION: Notice.
(5) No income eligibility standard will be Accessibility Policy
imposed on individuals with respect to SUMMARY: The Food and Drug
eligibility for assistance or services supported As the Authorized Organizational
Representative (AOR) signing this Administration (FDA) is denying a
with funds appropriated to carry out the request for a hearing submitted by Dr.
FVPSA (§ 10406(c)(3)). application on behalf of [Insert full, formal
name of applicant organization] John D. Noonan (Dr. Noonan), and is
(6) No fees will be levied for assistance or issuing an order under the Federal
services provided with funds appropriated to I hereby attest and certify that:
carry out the FVPSA (§ 10406(c)(3)). The needs of lesbian, gay, bisexual, Food, Drug, and Cosmetic Act (the
(7) The address or location of any shelter transgender, and questioning (also known as FD&C Act) debarring Dr. Noonan for 2
or facility assisted under the FVPSA that ‘‘Two-Spirited’’) program participants are years from providing services in any
otherwise maintains a confidential location taken into consideration in applicant’s capacity to a person that has an
will, except with written authorization of the program design. Applicant considered how approved or pending drug product
its program will be inclusive of and non-
person or persons responsible for the application. FDA bases this order on a
operation of such shelter, not be made public stigmatizing toward such participants. If not
already in place, awardee and, if applicable, finding that Dr. Noonan was convicted
(§ 10406(c)(5)(H)). of a misdemeanor under Federal law for
(8) Procedures are established to ensure subawardees must establish and publicize
policies prohibiting harassment based on conduct relating to the regulation of a
compliance with the provisions of drug product under the FD&C Act and
§ 10406(c)(5) regarding non-disclosure of race, sexual orientation, gender, gender
confidential of private information identity (or expression), religion, and that the type of conduct underlying the
(§ 10407(a)(2)(A)). national origin. The submission of an conviction undermines the process for
(9) The applicant or grantee will comply application for this funding opportunity the regulation of drugs. In determining
with the conditions set forth in the FVPSA constitutes an assurance that applicants have the appropriateness and period of Dr.
at § 10406(c)(5) and all other FVPSA or will put such policies in place within 12 Noonan’s debarment, FDA has
months of the award. Awardees should
obligations regarding non-disclosure of considered the relevant factors listed in
confidential or private information. These ensure that all staff members are trained to
prevent and respond to harassment or the FD&C Act. Dr. Noonan has failed to
include, but are not limited to, the following file with the Agency information and
requirements: (A) Grantees shall not disclose bullying in all forms during the award
period. Programs should be prepared to analyses sufficient to create a basis for
any personally identifying information a hearing concerning this action.
collected in connection with services monitor claims, address them seriously, and
requested (including services utilized or document their corrective action(s) so all DATES: The order is effective March 5,
denied), through grantee’s funded activities participants are assured that programs are 2015.
or reveal personally identifying information safe, inclusive, and non-stigmatizing by
design and in operation. In addition, any ADDRESSES: Submit applications for
without informed, written, reasonably time- termination of debarment to the
limited consent by the person about whom subawardees or subcontractors:
information is sought, whether for the • Have in place or will put into place Division of Dockets Management (HFA–
FVPSA-funded activities or any other federal within 12 months of the award policies 305), Food and Drug Administration,
or state program (additional consent prohibiting harassment based on race, sexual 5630 Fishers Lane, Rm. 1061, Rockville,
requirements have been omitted but see orientation, gender, gender identity (or MD 20852.
§ 10406(c)(5)(B)(ii)(I) for further expression), religion, and national origin; FOR FURTHER INFORMATION CONTACT:
requirements); (B) grantees may not release • Will enforce these policies;
• Will ensure that all staff will be trained
Nathan Doty, Office of Scientific
information compelled by statutory or court Integrity, Food and Drug
order unless adhering to the requirements of during the award period on how to prevent
mstockstill on DSK4VPTVN1PROD with NOTICES
and respond to harassment or bullying in all Administration, 10903 New Hampshire
§ 10406(c)(5)(C); (C) grantees may share non- Ave., Silver Spring, MD 20993, 301–
personally identifying information in the forms, and;
aggregate for the purposes enunciated in • Have or will have within 12 months of 796–8556.
§ 10406(c)(5)(D)(i) as well as for other the award, a plan to monitor claims, address SUPPLEMENTARY INFORMATION:
purposes found in § 10406(c)(5)(D)(ii) and them seriously, and document their
corrective action(s). I. Background
(iii).
(10) As prescribed by § 10406(c)(2) of the Insert Date of Signature: On August 11, 2009, in the U.S.
FVPSA, the Tribe will use grant funds in a Print Name and Title of the AOR: District Court for the Northern District
VerDate Sep<11>2014 20:45 Mar 04, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\05MRN1.SGM 05MRN1](https://thefederalregister.org/doc/80_FR_12050/page/1.svg)
![12008 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
of New York, Dr. Noonan, a physician, conduct that resulted in his violation of applicable considerations under section
pled guilty to a misdemeanor under the the FD&C Act. 306(c)(3) of the FD&C Act: (1) The
FD&C Act, namely misbranding a drug Hearings are granted only if there is nature and seriousness of his offense
in violation of sections 301(k), 502(i)(3) a genuine and substantial issue of fact. under section 306(c)(3)(A); (2) the
and 303(a)(1) of the FD&C Act (21 U.S.C. Hearings will not be granted on issues nature and extent of management
331(k), 352(i)(3), 333(a)(1)) and 18 of policy or law, on mere allegations, participation in the offense under
U.S.C. 2. The basis for this conviction denials, or general descriptions of section 306(c)(3)(B); (3) the nature and
was conduct surrounding his injection positions and contentions, or on data extent of voluntary steps taken to
of patients seeking treatment with and information insufficient to justify mitigate the impact on the public under
BOTOX/BOTOX Cosmetic (BOTOX) the factual determination urged or the section 306(c)(3)(C); and (4) prior
with a product, TRI-toxin, distributed action requested (see 21 CFR 12.24(b)). convictions involving matters within
by Toxin Research International, Inc. The Chief Scientist has considered Dr. the jurisdiction of FDA under section
BOTOX is a biological product derived Noonan’s arguments, as well as the 306(c)(3)(F). ORA found with respect to
from Botulinum Toxin Type A that is proposal to debar itself, and concludes Dr. Noonan that the first two
manufactured by Allergan, Inc., and was that, although Dr. Noonan has failed to considerations weigh in favor of
approved by FDA for use on humans for raise a genuine and substantial issue of debarment and noted that the third and
the treatment of facial wrinkles in 1991. fact requiring a hearing, the appropriate fourth considerations would be treated
According to the records of the criminal period of debarment is 2 years. as favorable factors for him. In making
proceedings, Dr. Noonan’s colleague in II. Arguments all of its findings under section 306(c)(3)
the same medical practice, The Plastic of the FD&C Act, ORA characterized Dr.
In support of his hearing request, Dr. Noonan’s conduct based on records
Surgery Group (TPSG), directed a nurse
Noonan first asserts that he is not from his criminal proceedings.
to obtain 31 vials of TRI-toxin, an
subject to debarment under section Under section 306(c)(3)(A) of the
unapproved drug product, which was
306(b)(2)(B)(i)(I) of the FD&C Act. He FD&C Act, in determining the
represented by its distributor as contends that he pled guilty to a
‘‘Botulinum Toxin Type A.’’ Dr. Noonan appropriateness and period of
misdemeanor violation of the FD&C Act debarment, FDA considers ‘‘the nature
then proceeded to inject approximately (see section 303(a)(1)), which is a strict
10 patients, who believed they were and seriousness of the offense
liability offense, and that thus there was involved.’’ In the proposal to debar,
being injected with BOTOX, with TRI- no demonstration or admission of
toxin as a substitute. ORA relied on the criminal information
criminal intent or knowledge to which Dr. Noonan pled guilty to find
Dr. Noonan is subject to debarment underlying the conviction. Dr. Noonan that the conduct underlying his
based on a finding, under section concludes, therefore, that the conduct convictions:
306(b)(2)(B)(i)(I) of the FD&C Act (21 underlying his conviction did not
U.S.C. 335a(b)(2)(B)(i)(I)): (1) That he created a risk of injury to consumers due to
undermine the process for the the use of an unapproved drug, undermined
was convicted of a misdemeanor under regulation of drugs. [FDA’s] oversight of an approved drug
Federal law relating to the regulation of Section 306(b)(2)(B)(i)(I) of the FD&C product by representing that [he] used the
a drug product under the FD&C Act and Act specifically provides for the approved drug while actually substituting an
(2) that the type of conduct underlying debarment of individuals convicted of unapproved drug in its place, and seriously
the conviction undermines the process Federal misdemeanors related to the undermined the integrity of [FDA’s]
for the regulation of drugs. By notice to regulation of drug products under the regulation of drug products.
Dr. Noonan dated November 30, 2010, FD&C Act. Given that misdemeanor Under section 306(c)(3)(B) of the FD&C
FDA’s Office of Regulatory Affairs violations of the FD&C Act themselves Act, ORA also considered the ‘‘nature
(ORA) proposed to debar him for 4 years are strict liability offenses, it stands to and extent of [Dr. Noonan’s]
from providing services in any capacity reason that criminal intent is not a management participation in the
to a person having an approved or critical component to debar an offense’’ and specifically found that he
pending drug product application. individual under section was a corporate principal who ‘‘pleaded
In a letter dated December 30, 2010, 306(b)(2)(B)(i)(I). During his criminal guilty to misbranding TRI-toxin’’ and
through counsel, Dr. Noonan requested proceedings, Dr. Noonan pled guilty to ‘‘participated in the [TPSG’s] unlawful
a hearing on the proposal. In his request misbranding and causing the conduct of administering [an]
for a hearing, Dr. Noonan acknowledges misbranding of a drug in violation of unapproved drug on multiple occasions
his conviction under Federal law, as sections 301(k), 502(i)(3) and 303(a)(1) to patients.’’ ORA concluded, therefore,
alleged by FDA. By letter dated January of the FD&C Act by offering an that the nature and seriousness of
28, 2011, Dr. Noonan submitted unapproved drug, TRI-toxin, for sale as Noonan’s offenses and the nature and
materials and arguments in support of an approved drug product, BOTOX. Dr. extent of management participation
his request. Dr. Noonan acknowledges Noonan’s conduct undermined the were unfavorable factors with respect to
that he was convicted of a Federal process for the regulation of drugs in him.
misdemeanor, as found in the proposal that it permitted an unapproved drug to Dr. Noonan counters ORA’s findings
to debar, but argues that he should not be substituted for an approved drug with respect to those two considerations
be debarred for reasons related to the without the knowledge of the patient. in section 306(c)(3) of the FD&C Act
factual basis set forth in the proposal to As a result, Dr. Noonan is, in fact, with the following arguments: (1) That
debar. In particular, with respect to the subject to debarment under section he did not admit any criminal intent or
mstockstill on DSK4VPTVN1PROD with NOTICES
considerations for determining the 306(b)(2)(B)(i)(I) of the FD&C Act. intentional wrongdoing when he pled
appropriateness and period of Dr. Noonan next challenges the guilty to a misdemeanor offense under
debarment under section 306(c)(3) of the manner in which ORA applied the the FD&C Act; (2) that, in fact, another
FD&C Act, he argues that there are considerations under section 306(c)(3) physician at TPSG took unilateral action
genuine and substantial issues of fact for of the FD&C Act in determining the in ordering the TRI-toxin and directing
resolution at a hearing, namely factual appropriateness and period of his a nurse to substitute it for BOTOX; (3)
issues bearing on whether he debarment. In the proposal to debar Dr. that the TRI-toxin vials that they used
participated in or even knew of certain Noonan, ORA stated that there are four for injecting patients with TRI-toxin
VerDate Sep<11>2014 19:28 Mar 04, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\05MRN1.SGM 05MRN1](https://thefederalregister.org/doc/80_FR_12050/page/2.svg)
![Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 12009
were identical to the vials he used for [BOTOX] until your discovery of it in information to which Dr. Noonan pled
BOTOX before the substitution; and (4) November of 2004.’’ guilty alleges that TPSG began ordering
that since the conviction for the In short, consistent with the proposal TRI-toxin for use in the medical
underlying misdemeanor was of an to debar Dr. Noonan for 4 years, the practice. It is undisputed that Dr.
individual, that there was no records of his criminal proceedings Noonan is a principal in TPSG, and this
management participation and that, establish that the misdemeanor is the basis for considering the nature
thus, the nature and extent of convictions for the physicians in TPSG and extent of management participation
management participation is other than DeLuca were not based on as a factor in determining the
inapplicable as a factor in determining any affirmative involvement in ordering appropriateness and period of
appropriateness and period of the TRI-toxin or substituting the TRI- debarment. FDA has relied on this factor
debarment. Dr. Noonan concedes that he toxin for BOTOX. Furthermore, in in other debarment cases where the
pled guilty to the misdemeanor offense proposing to debar Dr. Noonan for 4 underlying conviction was of an
because he was, in fact, guilty of years, ORA did not rely on any findings individual (see 78 FR 68455 (November
offering TRI-toxin for sale to their with respect to Dr. Noonan’s intent or 14, 2013), 77 FR 27236 (May 9, 2012)).
patients as BOTOX. He argues, however, knowledge. Rather, citing the records of The limited scope of his direct actions
that the criminal records do not Dr. Noonan’s criminal proceedings, the in committing the underlying
establish any intent or knowledge on his proposal to debar simply rests on Dr. misdemeanor offense does not mitigate
part and that thus the conduct Noonan’s position of authority within the extent of his management
underlying his conviction does not TPSG and his conduct in misbranding participation, as established during his
warrant debarment in light of the TRI-toxin by administering it to patients criminal proceedings and as set out in
considerations in section 306(c)(3) of who believed they were receiving the proposal to debar. It is true that
the FD&C Act. BOTOX. As a result, under § 12.24(b), nothing in the criminal proceedings or
As noted previously, ORA relied on there is no genuine and substantial issue the proposal to debar reflects any
the records of Dr. Noonan’s criminal of fact raised by Dr. Noonan’s arguments involvement by him in the decision to
proceedings for its findings in the for resolution at a hearing. order the TRI-toxin and substitute it for
proposal to debar. There is nothing As set forth in the proposal to debar BOTOX, and the proposal to debar
definitive in the criminal records before and summarized previously, Dr. Noonan specifically finds that another physician
FDA to contradict Dr. Noonan’s pled guilty to a misdemeanor under the authorized a nurse to place that order.
assertions with respect to the nature of FD&C Act for his role in offering a drug However, Dr. Noonan, as a principal of
his involvement in the misdemeanor under the name of another. Based on the TPSG, was responsible for failing to
offense to which he pled guilty. The undisputed record before the Agency, ensure that there were controls and
criminal information to which Dr. the consideration in section 306(c)(3)(A) procedures in place to prevent other
Noonan pled guilty alleges that TPSG, of the FD&C Act with respect to the
physicians or a nurse from ordering
as opposed to Dr. Noonan, began nature and seriousness of the offense
unapproved drugs for administration to
ordering TRI-toxin for use in the involved is a favorable factor. As
patients. His own admitted inaction on
medical practice, and there are no reflected in the records of the criminal
that front warrants treating his
allegations that Dr. Noonan took part in proceedings, Dr. Noonan’s offense did
management participation as an
the ordering process. Indeed, the not rest on any intent or knowledge of
unfavorable factor.1
proposal to debar states that, as claimed wrongdoing on his part, nor may such
Consistent with the proposal to debar,
by Dr. Noonan, another physician in the intent or knowledge be inferred from the
the record establishes that the medical
practice, William F. DeLuca, Jr., was circumstances of his offense or the
findings in the proposal to debar. practice of which Dr. Noonan was a part
responsible for authorizing a nurse to ultimately took voluntary steps to
substitute TRI-toxin for BOTOX, not Dr. Although, as a practicing physician, Dr.
Noonan should be expected to take the mitigate the effect on the public health
Noonan. At Dr. Noonan’s sentencing from its unlawful conduct (see section
hearing, at which six other appropriate steps to avoid administering
an unapproved new drug to patients or 306(c)(3)(C) of the FD&C Act).
codefendants, including DeLuca, were Furthermore, it is undisputed that Dr.
also sentenced, the presiding judge also misrepresenting the drug being
administered, his failure to do so over Noonan had no previous criminal
made clear that he believed DeLuca was convictions related to matters within the
the physician responsible for making a 10-month period does not warrant
considering the nature and seriousness jurisdiction of FDA (see section
the ‘‘mistake’’ that led to the other 306(c)(3)(F) of the FD&C Act). Therefore,
physician’s offenses. In addressing of his offense as an unfavorable factor,
relative to the range of conduct that these will be treated as favorable factors.
DeLuca, the court stated: In light of the foregoing four
might underlie a Federal misdemeanor
And we’re here because of your actions and conviction. considerations, one of which weighs
inactions. As I said, your mistakes were against Dr. Noonan, debarment for 2
On the other hand, because of Dr.
different in kind and degree from those of years is appropriate.
your colleagues. It was you who brought this Noonan’s position of authority within
drug into the practice, and it was your TPSG and, thus, presumed ability to III. Findings and Order
conduct and your failure to check out either prevent the series of events that resulted
the company or the drug that you were in the offense underlying his Therefore, the Chief Scientist, under
ordering, as you should have done, your misdemeanor conviction, the nature and section 306(b)(2)(B)(i)(I) of the FD&C
negligence in doing that that has brought us extent of management participation in Act and under authority delegated to
here today in the end. him, finds that Dr. Noonan has been
mstockstill on DSK4VPTVN1PROD with NOTICES
the offense is an unfavorable factor, for
In addressing Dr. Noonan, the court the purposes of the consideration under convicted of a misdemeanor under
further stated: ‘‘There have been 306(c)(3)(B) of the FD&C Act. Dr. Federal law for conduct relating to the
disputes on how in the past over who Noonan asserts that there was no development or approval of a drug
knew what and at what point in time. management participation, and that, 1 See United States v. Park, 421 U.S. 658, 673–
It is clear from the facts in this case that thus, this factor is inapplicable because 74 (1975) (holding that a high-level manager within
you had no knowledge that the the underlying conviction was of an a business entity bears a responsibility to prevent
substance was anything other than individual. However, the criminal and correct violations of the FD&C Act).
VerDate Sep<11>2014 19:28 Mar 04, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\05MRN1.SGM 05MRN1](https://thefederalregister.org/doc/80_FR_12050/page/3.svg)
![12010 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
product or otherwise relating to the DEPARTMENT OF HEALTH AND MD 20993–0002, 240–402–6019, email:
regulation of a drug product under the HUMAN SERVICES COApublicworkshop@fda.hhs.gov.
FD&C Act and that the conduct Registration: Registration is free for
underlying the conviction undermines Food and Drug Administration the public workshop. Interested parties
the regulation of drugs. FDA has [Docket No. FDA–2015–N–0001] are encouraged to register early because
considered the relevant factors listed in space is limited to 150 attendees.
section 306(c)(3) of the FD&C Act and Clinical Outcomes Assessment Workshop space will be filled in order
determined that a debarment of 2 years Development and Implementation: of receipt of registration. Those accepted
is appropriate. Opportunities and Challenges; Public in to the workshop will receive
Workshop confirmation. Registration will close
As a result of the foregoing findings, after the workshop is filled. Registration
Dr. Noonan is debarred for 2 years from AGENCY: Food and Drug Administration, at the site is not guaranteed but may be
providing services in any capacity to a HHS. possible on a space available basis on
person with an approved or pending ACTION: Notice of public workshop. the day of the public workshop
drug product application under section beginning at 7:30 a.m. If registration is
505, 512, or 802 of the FD&C Act (21 The Food and Drug Administration
filled, attendance to the workshop will
U.S.C. 355, 360b, or 382), or under (FDA) is announcing a public workshop
be available only through the Webcast.
entitled ‘‘Clinical Outcomes Assessment
section 351 of the Public Health Service To register, visit http://www.fda.gov/
Development and Implementation:
Act (42 U.S.C. 262), effective (see Drugs/NewsEvents/ucm431040.htm. For
Opportunities and Challenges.’’ The
DATES) (see 21 U.S.C. 335a(c)(1)(B) and those without Internet access, please
purpose of the public workshop is to
(c)(2)(A)(iii) and 21 U.S.C. 321(dd)). call Michelle Campbell (See Contact
provide updates on accomplishments,
Any person with an approved, or Person) to register.
challenges, and ongoing efforts in the
pending, drug product application, who If you need special accommodations
use of clinical outcome assessments
knowingly uses the services of Dr. due to a disability, please contact
(COAs), and plan for the future of COA
Noonan, in any capacity during his Michelle Campbell (See Contact Person)
development and utilization in drug
period of debarment, will be subject to at least 7 days in advance.
development programs, including how
civil money penalties. If Dr. Noonan, to incorporate the patient voice in drug SUPPLEMENTARY INFORMATION: The
during his period of debarment, development using well-defined and Center for Drug Evaluation and Research
provides services in any capacity to a reliable patient-centered outcome (CDER) reviews COAs, including
person with an approved or pending measures. The public workshop will patient-reported outcome measures,
drug product application he will be also discuss standards for COA use and clinician-reported outcome measures,
subject to civil money penalties. In collaborative processes for COA and observer-reported outcome
addition, FDA will not accept or review development and dissemination. measures, when submitted with an
any abbreviated new drug applications Date and Time: The public workshop investigational new drug application, a
submitted by or with the assistance of will be held on April 1, 2015, from 8:30 new drug application, or a biologics
Dr. Noonan during his period of a.m. to 5 p.m. Participants are licensing application. CDER also
encouraged to arrive early to ensure reviews a COA when submitted for
debarment.
time for parking and routine security qualification as a drug development
Any application by Dr. Noonan for checks before the workshop. tool. Qualification of a COA is a
termination of debarment under section Location: The public workshop will regulatory determination that the COA
306(d) of the FD&C Act should be be held at the FDA White Oak Campus, is well-suited for a specific context of
identified with Docket No. FDA–2010– 10903 New Hampshire Ave., Building use in drug development. Following a
N–0300 and sent to the Division of 31 Conference Center, The Great Room public announcement of the
Dockets Management (see ADDRESSES). (Rm. 1503), Silver Spring, MD 20993– qualification decision by FDA, the COA
All such submissions are to be filed in 0002. Entrance for the public workshop will be publicly available for use in any
four copies. The public availability of participants (non-FDA employees) is appropriate drug development program.
information in these submissions is through Building 1 where routine This workshop will focus on current
governed by 21 CFR 10.20(j). Publicly security check procedures will be challenges and opportunities in COA
available submissions may be seen in performed. For parking and security development and use, including
the Division of Dockets Management information, please refer to http:// establishing appropriate standards for
between 9 a.m. and 4 p.m., Monday www.fda.gov/AboutFDA/ use; current efforts to encourage
through Friday. Persons with access to WorkingatFDA/BuildingsandFacilities/ inclusion of well-defined and reliable
the Internet may obtain documents in WhiteOakCampusInformation/ patient-centered outcome measures in
the Docket at http:// ucm241740.htm. Attendees are drug development; use of collaborative
www.regulations.gov/. responsible for their own efforts in developing and utilizing COAs
accommodations. through various partnerships; and future
Dated: February 24, 2015. The public workshop will also be efforts to address challenges and gaps of
Stephen Ostroff, available to be viewed online via COA development and use for patient-
Director, Office of the Chief Scientist. Webcast at https:// centered drug development and medical
[FR Doc. 2015–05042 Filed 3–4–15; 8:45 am] collaboration.fda.gov/ product labeling.
mstockstill on DSK4VPTVN1PROD with NOTICES
COApublicworkshop2015. Persons For more information on this public
BILLING CODE 4164–01–P
interested in participating by Webcast workshop, visit http://www.fda.gov/
must register online by March 27, 2015. Drugs/NewsEvents/ucm431040.htm.
Contact Person: Michelle Campbell, The Agency encourages patient
Center for Drug Evaluation and advocates, health care providers,
Research, Food and Drug researchers, regulators, individuals from
Administration, 10903 New Hampshire academia, industry, and other interested
Ave., Bldg. 22, Rm. 6471, Silver Spring, persons to attend this public workshop.
VerDate Sep<11>2014 19:28 Mar 04, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\05MRN1.SGM 05MRN1](https://thefederalregister.org/doc/80_FR_12050/page/4.svg)
Document Created: 2015-12-18 12:08:52
Document Modified: 2015-12-18 12:08:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The order is effective March 5, 2015. | |
| Contact | Nathan Doty, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8556. | |
| FR Citation | 80 FR 12007 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR