80 FR 11995 - Douglas M. Hargrave; 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 | 11995-11998 | |
| FR Document | 2015-05046 |
[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)] [Notices] [Pages 11995-11998] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05046] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0299] Douglas M. Hargrave; 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. Douglas M. Hargrave (Dr. Hargrave), and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr. Hargrave 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. Hargrave 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. Hargrave's debarment, FDA has considered the relevant factors listed in the FD&C Act. Dr. Hargrave 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 of New York, Dr. Hargrave, 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. Hargrave'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. Hargrave then proceeded to inject approximately 25 patients, who believed they were being injected with BOTOX, with TRI-toxin as a substitute. Dr. Hargrave 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 [[Page 11996]] 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. Hargrave 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. Hargrave requested a hearing on the proposal. In his request for a hearing, Dr. Hargrave acknowledges his conviction under Federal law, as alleged by FDA. By letter dated January 28, 2011, Dr. Hargrave submitted materials and arguments in support of his request. Dr. Hargrave 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. Hargrave's arguments, as well as the proposal to debar itself, and concludes that, although Dr. Hargrave 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. Hargrave 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) of the FD&C Act), which is a strict liability offense, and that thus there was no demonstration or admission of criminal intent or knowledge underlying the conviction. Dr. Hargrave 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. Hargrave 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. Hargrave'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. Hargrave is, in fact, subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act. Dr. Hargrave 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. Hargrave, 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. Hargrave 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) FD&C Act, ORA characterized Dr. Hargrave'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. Hargrave 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. Hargrave'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 Dr. Hargrave's offenses and the nature and extent of management participation were unfavorable factors with respect to him. Dr. Hargrave 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 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. Hargrave 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. Hargrave's criminal proceedings for its findings in the proposal to debar. There is nothing definitive in the criminal records before FDA to contradict Dr. Hargrave'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. [[Page 11997]] Hargrave pled guilty alleges that TPSG, as opposed to Dr. Hargrave, began ordering TRI-toxin for use in the medical practice, and there are no allegations that Dr. Hargrave took part in the ordering process. Indeed, the proposal to debar states that, as claimed by Dr. Hargrave, another physician in the practice, William F. DeLuca, Jr., was responsible for authorizing a nurse to substitute TRI-toxin for BOTOX, not Dr. Hargrave. At Dr. Hargrave'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 one of the other three physicians who pled guilty under circumstances similar to Dr. Hargrave's, 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. Hargrave 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. Hargrave for 4 years, ORA did not rely on any findings with respect to Dr. Hargrave's intent or knowledge. Rather, citing the records of Dr. Hargrave's criminal proceedings, the proposal to debar simply rests on Dr. Hargrave'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. Hargrave's arguments for resolution at a hearing. As set forth in the proposal to debar and summarized previously, Dr. Hargrave 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. Hargrave'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. Hargrave 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 t10-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. Hargrave'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. Hargrave 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. Hargrave pled guilty alleges that TPSG began ordering TRI-toxin for use in the medical practice. It is undisputed that Dr. Hargrave 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 27236-01 (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. Hargrave, 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. Hargrave 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. Hargrave 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. Hargrave, 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. Hargrave has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug 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. Hargrave 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. Hargrave, in any capacity during his period of debarment, will be subject to civil money penalties. If Dr. Hargrave, during his period of debarment, provides services in any capacity to a [[Page 11998]] 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. Hargrave during his period of debarment. Any application by Dr. Hargrave for termination of debarment under section 306(d) of the FD&C Act should be identified with Docket No. FDA-2010-N-0299 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. 2015-05046 Filed 3-4-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 11995
Date: March 31, 2015. of Health, Center for Scientific Review, 6701 approved or pending drug product
Time: 8:00 a.m. to 9:00 p.m. Rockledge Drive, Rm 5205, MSC 7846, application. FDA bases this order on a
Agenda: To review and evaluate Bethesda, MD 20892, (301) 435–1021, finding that Dr. Hargrave was convicted
cooperative agreement applications. rovescaa@mail.nih.gov. of a misdemeanor under Federal law for
Place: Residence Inn Washington DC, 1199 Name of Committee: Center for Scientific
Vermont Avenue NW., Washington, DC conduct relating to the regulation of a
Review Special Emphasis Panel; ‘‘Program drug product under the FD&C Act and
20005. Project: BTRC Center Review’’.
Contact Person: Kenneth Ryan, Ph.D., that the type of conduct underlying the
Date: March 31–April 2, 2015.
Scientific Review Officer, Center for Time: 6:00 p.m. to 5:00 p.m. conviction undermines the process for
Scientific Review, National Institutes of Agenda: To review and evaluate grant the regulation of drugs. In determining
Health, 6701 Rockledge Drive, Room 3218, applications. the appropriateness and period of Dr.
MSC 7717, Bethesda, MD 20892, 301–435– Place: Bethesda Marriott Suites, 6711 Hargrave’s debarment, FDA has
0229, kenneth.ryan@nih.hhs.gov. Democracy Boulevard, Bethesda, MD 20817. considered the relevant factors listed in
Name of Committee: Center for Scientific Contact Person: Craig Giroux, Ph.D., the FD&C Act. Dr. Hargrave has failed to
Review Special Emphasis Panel; Member Scientific Review Officer, BST IRG, Center file with the Agency information and
Conflict: Pregnancy/Neonatology Research. for Scientific Review, National Institutes of analyses sufficient to create a basis for
Date: March 31, 2015. Health, 6701 Rockledge Drive, Room 5150,
Time: 9:00 a.m. to 5:00 p.m.
a hearing concerning this action.
Bethesda, MD 20892, 301–435–2204,
Agenda: To review and evaluate grant girouxcn@csr.nih.gov. DATES: The order is effective March 5,
applications. Name of Committee: Center for Scientific
2015.
Place: National Institutes of Health, 6701 Review Special Emphasis Panel; RFA–RM– ADDRESSES: Submit applications for
Rockledge Drive, Bethesda, MD 20892, 14–015: Facile Methods and Technologies for termination of debarment to the
(Virtual Meeting). Synthesis of Biomedically Relevant
Contact Person: Gary Hunnicutt, Ph.D.,
Division of Dockets Management (HFA–
Carbohydrates. 305), Food and Drug Administration,
Scientific Review Officer, Center for Date: March 31, 2015.
Scientific Review, National Institutes of 5630 Fishers Lane, Rm. 1061, Rockville,
Time: 12:00 p.m. to 6:00 p.m.
Health, 6701 Rockledge Drive, Room 6164, MD 20852.
Agenda: To review and evaluate grant
MSC 7892, Bethesda, MD 20892, 301–435– applications. FOR FURTHER INFORMATION CONTACT:
0229, gary.hunnicutt@nih.gov. Place: National Institutes of Health, 6701 Nathan Doty, Office of Scientific
Name of Committee: Center for Scientific Rockledge Drive, Bethesda, MD 20892. Integrity, Food and Drug
Review Special Emphasis Panel; Small Contact Person: Kathryn M. Koeller, Ph.D., Administration, 10903 New Hampshire
Business: Innovative Molecular Analysis Scientific Review Officer, Center for Ave., Silver Spring, MD 20993, 301–
Technology. Scientific Review, National Institutes of 796–8556.
Date: March 31, 2015. Health, 6701 Rockledge Drive, Room 4166,
Time: 1:00 p.m. to 5:00 p.m. SUPPLEMENTARY INFORMATION:
MSC 7806, Bethesda, MD 20892, 301–435–
Agenda: To review and evaluate grant 2681, koellerk@csr.nih.gov. I. Background
applications. (Catalogue of Federal Domestic Assistance
Place: National Institutes of Health, 6701 On August 11, 2009, in the U.S.
Program Nos. 93.306, Comparative Medicine;
Rockledge Drive, Bethesda, MD 20892, 93.333, Clinical Research, 93.306, 93.333,
District Court for the Northern District
(Telephone Conference Call). 93.337, 93.393–93.396, 93.837–93.844, of New York, Dr. Hargrave, a physician,
Contact Person: Zhang-Zhi Hu, MD, 93.846–93.878, 93.892, 93.893, National pled guilty to a misdemeanor under the
Scientific Review Officer, Center for Institutes of Health, HHS) FD&C Act, namely misbranding a drug
Scientific Review, National Institutes of in violation of sections 301(k), 502(i)(3)
Health, 6701 Rockledge Drive, Room 6186, Dated: February 27, 2015.
and 303(a)(1) of the FD&C Act (21 U.S.C.
MSC 7804, Bethesda, MD 20892, (301) 594– Anna Snouffer,
2414, huzhuang@csr.nih.gov.
331(k), 352(i)(3), 333(a)(1)) and 18
Deputy Director, Office of Federal Advisory U.S.C. 2. The basis for this conviction
Name of Committee: Center for Scientific Committee Policy.
Review Special Emphasis Panel; Member
was conduct surrounding his injection
[FR Doc. 2015–05008 Filed 3–4–15; 8:45 am]
Conflict: Cancer Therapeutics. of patients seeking treatment with
BILLING CODE 4140–01–P BOTOX/BOTOX Cosmetic (BOTOX)
Date: March 31, 2015.
Time: 1:00 p.m. to 4:00 p.m. with a product, TRI-toxin, distributed
Agenda: To review and evaluate grant by Toxin Research International, Inc.
applications. DEPARTMENT OF HEALTH AND BOTOX is a biological product derived
Place: National Institutes of Health, 6701 HUMAN SERVICES from Botulinum Toxin Type A that is
Rockledge Drive, Bethesda, MD 20892, manufactured by Allergan, Inc., and was
(Telephone Conference Call). Food and Drug Administration
approved by FDA for use on humans for
Contact Person: Careen K. Tang-Toth, [Docket No. FDA–2010–N–0299]
Ph.D., Scientific Review Officer, Center for
the treatment of facial wrinkles in 1991.
Scientific Review, National Institutes of According to the records of the criminal
Douglas M. Hargrave; Denial of proceedings, Dr. Hargrave’s colleague in
Health, 6701 Rockledge Drive, Room 6214, Hearing; Final Debarment Order
MSC 7804, Bethesda, MD 20892, (301) 435– the same medical practice, The Plastic
3504, tothct@csr.nih.gov. AGENCY: Food and Drug Administration, Surgery Group (TPSG), directed a nurse
Name of Committee: Center for Scientific HHS. to obtain 31 vials of TRI-toxin, an
Review Special Emphasis Panel; Member ACTION: Notice. unapproved drug product, which was
Conflict: Organelles’ Dysfunction in represented by its distributor as
Neurodegerative Disorders. SUMMARY: The Food and Drug ‘‘Botulinum Toxin Type A.’’ Dr.
Date: March 31, 2015.
mstockstill on DSK4VPTVN1PROD with NOTICES
Administration (FDA) is denying a Hargrave then proceeded to inject
Time: 4:00 p.m. to 6:00 p.m. request for a hearing submitted by Dr. approximately 25 patients, who
Agenda: To review and evaluate grant
Douglas M. Hargrave (Dr. Hargrave), and believed they were being injected with
applications.
Place: National Institutes of Health, 6701 is issuing an order under the Federal BOTOX, with TRI-toxin as a substitute.
Rockledge Drive, Bethesda, MD 20892, Food, Drug, and Cosmetic Act (the Dr. Hargrave is subject to debarment
(Telephone Conference Call). FD&C Act) debarring Dr. Hargrave for 2 based on a finding, under section
Contact Person: Alessandra C. Rovescalli, years from providing services in any 306(b)(2)(B)(i)(I) of the FD&C Act (21
Scientific Review Officer, National Institutes capacity to a person that has an U.S.C. 335a(b)(2)(B)(i)(I)): (1) That he
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![11996 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
was convicted of a misdemeanor under did not undermine the process for the created a risk of injury to consumers due to
Federal law relating to the regulation of regulation of drugs. the use of an unapproved drug, undermined
a drug product under the FD&C Act and [FDA’s] oversight of an approved drug
Section 306(b)(2)(B)(i)(I) of the FD&C
product by representing that [he] used the
(2) that the type of conduct underlying Act specifically provides for the approved drug while actually substituting an
the conviction undermines the process debarment of individuals convicted of unapproved drug in its place, and seriously
for the regulation of drugs. By notice to Federal misdemeanors related to the undermined the integrity of [FDA’s]
Dr. Hargrave dated November 30, 2010, regulation of drug products under the regulation of drug products.
FDA’s Office of Regulatory Affairs FD&C Act. Given that misdemeanor Under section 306(c)(3)(B) of the FD&C
(ORA) proposed to debar him for 4 years violations of the FD&C Act themselves Act, ORA also considered the ‘‘nature
from providing services in any capacity are strict liability offenses, it stands to and extent of [Dr. Hargrave’s]
to a person having an approved or reason that criminal intent is not a management participation in the
pending drug product application. critical component to debar an offense’’ and specifically found that he
In a letter dated December 30, 2010, individual under section was a corporate principal who ‘‘pleaded
through counsel, Dr. Hargrave requested 306(b)(2)(B)(i)(I). During his criminal guilty to misbranding TRI-toxin’’ and
a hearing on the proposal. In his request proceedings, Dr. Hargrave pled guilty to ‘‘participated in the [TPSG’s] unlawful
for a hearing, Dr. Hargrave misbranding and causing the conduct of administering [an]
acknowledges his conviction under misbranding of a drug in violation of unapproved drug on multiple occasions
Federal law, as alleged by FDA. By letter sections 301(k), 502(i)(3) and 303(a)(1) to patients.’’ ORA concluded, therefore,
dated January 28, 2011, Dr. Hargrave of the FD&C Act by offering an that the nature and seriousness of Dr.
submitted materials and arguments in unapproved drug, TRI-toxin, for sale as Hargrave’s offenses and the nature and
support of his request. Dr. Hargrave an approved drug product, BOTOX. Dr. extent of management participation
acknowledges that he was convicted of Hargrave’s conduct undermined the were unfavorable factors with respect to
a Federal misdemeanor, as found in the process for the regulation of drugs in him.
proposal to debar, but argues that he that it permitted an unapproved drug to Dr. Hargrave counters ORA’s findings
should not be debarred for reasons be substituted for an approved drug with respect to those two considerations
related to the factual basis set forth in without the knowledge of the patient. in section 306(c)(3) of the FD&C Act
the proposal to debar. In particular, with As a result, Dr. Hargrave is, in fact, with the following arguments: (1) That
respect to the considerations for subject to debarment under section he did not admit any criminal intent or
determining the appropriateness and 306(b)(2)(B)(i)(I) of the FD&C Act. intentional wrongdoing when he pled
period of debarment under section Dr. Hargrave next challenges the guilty to a misdemeanor offense under
306(c)(3) of the FD&C Act, he argues manner in which ORA applied the the FD&C Act; (2) that, in fact, another
that there are genuine and substantial considerations under section 306(c)(3) physician at TPSG took unilateral action
issues of fact for resolution at a hearing, of the FD&C Act in determining the in ordering the TRI-toxin and directing
namely factual issues bearing on appropriateness and period of his a nurse to substitute it for BOTOX; (3)
whether he participated in or even knew debarment. In the proposal to debar Dr. that the TRI-toxin vials that they used
of certain conduct that resulted in his Hargrave, ORA stated that there are four for injecting patients with TRI-toxin
violation of the FD&C Act. applicable considerations under section were identical to the vials he used for
Hearings are granted only if there is 306(c)(3) of the FD&C Act: (1) The BOTOX before the substitution; and (4)
a genuine and substantial issue of fact. nature and seriousness of his offense that since the conviction for the
Hearings will not be granted on issues under section 306(c)(3)(A); (2) the underlying misdemeanor was of an
of policy or law, on mere allegations, nature and extent of management individual, that there was no
denials, or general descriptions of participation in the offense under management participation and that,
positions and contentions, or on data section 306(c)(3)(B); (3) the nature and thus, the nature and extent of
and information insufficient to justify extent of voluntary steps taken to management participation is
the factual determination urged or the mitigate the impact on the public under inapplicable as a factor in determining
action requested (see 21 CFR 12.24(b)). section 306(c)(3)(C); and (4) prior appropriateness and period of
The Chief Scientist has considered Dr. convictions involving matters within debarment. Dr. Hargrave concedes that
Hargrave’s arguments, as well as the the jurisdiction of FDA under section he pled guilty to the misdemeanor
proposal to debar itself, and concludes 306(c)(3)(F). ORA found with respect to offense because he was, in fact, guilty of
that, although Dr. Hargrave has failed to Dr. Hargrave that the first two offering TRI-toxin for sale to their
raise a genuine and substantial issue of considerations weigh in favor of patients as BOTOX. He argues, however,
fact requiring a hearing, the appropriate debarment and noted that the third and that the criminal records do not
period of debarment is 2 years. fourth considerations would be treated establish any intent or knowledge on his
as favorable factors for him. In making part and that thus the conduct
II. Arguments all of its findings under section 306(c)(3) underlying his conviction does not
In support of his hearing request, Dr. FD&C Act, ORA characterized Dr. warrant debarment in light of the
Hargrave first asserts that he is not Hargrave’s conduct based on records considerations in section 306(c)(3) of
subject to debarment under section from his criminal proceedings. the FD&C Act.
306(b)(2)(B)(i)(I) of the FD&C Act. He Under section 306(c)(3)(A) of the As noted previously, ORA relied on
contends that he pled guilty to a FD&C Act, in determining the the records of Dr. Hargrave’s criminal
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misdemeanor violation of the FD&C Act appropriateness and period of proceedings for its findings in the
(see section 303(a)(1) of the FD&C Act), debarment, FDA considers ‘‘the nature proposal to debar. There is nothing
which is a strict liability offense, and and seriousness of the offense definitive in the criminal records before
that thus there was no demonstration or involved.’’ In the proposal to debar, FDA to contradict Dr. Hargrave’s
admission of criminal intent or ORA relied on the criminal information assertions with respect to the nature of
knowledge underlying the conviction. to which Dr. Hargrave pled guilty to his involvement in the misdemeanor
Dr. Hargrave concludes, therefore, that find that the conduct underlying his offense to which he pled guilty. The
the conduct underlying his conviction convictions: criminal information to which Dr.
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![Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 11997
Hargrave pled guilty alleges that TPSG, another. Based on the undisputed However, Dr. Hargrave, as a principal of
as opposed to Dr. Hargrave, began record before the Agency, the TPSG, was responsible for failing to
ordering TRI-toxin for use in the consideration in section 306(c)(3)(A) of ensure that there were controls and
medical practice, and there are no the FD&C Act with respect to the nature procedures in place to prevent other
allegations that Dr. Hargrave took part in and seriousness of the offense involved physicians or a nurse from ordering
the ordering process. Indeed, the is a favorable factor. As reflected in the unapproved drugs for administration to
proposal to debar states that, as claimed records of the criminal proceedings, Dr. patients. His own admitted inaction on
by Dr. Hargrave, another physician in Hargrave’s offense did not rest on any that front warrants treating his
the practice, William F. DeLuca, Jr., was intent or knowledge of wrongdoing on management participation as an
responsible for authorizing a nurse to his part, nor may such intent or unfavorable factor.1
substitute TRI-toxin for BOTOX, not Dr. knowledge be inferred from the Consistent with the proposal to debar,
Hargrave. At Dr. Hargrave’s sentencing circumstances of his offense or the the record establishes that the medical
hearing, at which six other findings in the proposal to debar. practice of which Dr. Hargrave was a
codefendants, including DeLuca, were Although, as a practicing physician, Dr. part ultimately took voluntary steps to
also sentenced, the presiding judge also Hargrave should be expected to take the mitigate the effect on the public health
made clear that he believed DeLuca was appropriate steps to avoid administering from its unlawful conduct (see section
the physician responsible for making an unapproved new drug to patients or 306(c)(3)(C) of the FD&C Act).
the ‘‘mistake’’ that led to the other misrepresenting the drug being Furthermore, it is undisputed that Dr.
physician’s offenses. In addressing administered, his failure to do so over Hargrave had no previous criminal
DeLuca, the court stated: a t10-month period does not warrant convictions related to matters within the
And we’re here because of your actions considering the nature and seriousness jurisdiction of FDA (see section
and inactions. As I said, your mistakes were of his offense as an unfavorable factor, 306(c)(3)(F) of the FD&C Act). Therefore,
different in kind and degree from those of relative to the range of conduct that these will be treated as favorable factors.
your colleagues. It was you who brought this might underlie a Federal misdemeanor In light of the foregoing four
drug into the practice, and it was your conviction. considerations, one of which weighs
conduct and your failure to check out either On the other hand, because of Dr.
the company or the drug that you were against Dr. Hargrave, debarment for 2
Hargrave’s position of authority within years is appropriate.
ordering, as you should have done, your
TPSG and, thus, presumed ability to
negligence in doing that that has brought us III. Findings and Order
here today in the end. prevent the series of events that resulted
in the offense underlying his Therefore, the Chief Scientist, under
In addressing one of the other three misdemeanor conviction, the nature and
physicians who pled guilty under section 306(b)(2)(B)(i)(I) of the FD&C
extent of management participation in Act and under authority delegated to
circumstances similar to Dr. Hargrave’s, the offense is an unfavorable factor, for
the court further stated: ‘‘There have him, finds that Dr. Hargrave has been
the purposes of the consideration under convicted of a misdemeanor under
been disputes on how in the past over 306(c)(3)(B) of the FD&C Act. Dr.
who knew what and at what point in Federal law for conduct relating to the
Hargrave asserts that there was no development or approval of a drug
time. It is clear from the facts in this management participation, and that,
case that you had no knowledge that the product or otherwise relating to the
thus, this factor is inapplicable because regulation of a drug product under the
substance was anything other than the underlying conviction was of an
[BOTOX] until your discovery of it in FD&C Act and that the conduct
individual. However, the criminal underlying the conviction undermines
November of 2004.’’ information to which Dr. Hargrave pled the regulation of drugs. FDA has
In short, consistent with the proposal guilty alleges that TPSG began ordering
to debar Dr. Hargrave for 4 years, the considered the relevant factors listed in
TRI-toxin for use in the medical section 306(c)(3) of the FD&C Act and
records of his criminal proceedings practice. It is undisputed that Dr.
establish that the misdemeanor determined that a debarment of 2 years
Hargrave is a principal in TPSG, and is appropriate.
convictions for the physicians in TPSG this is the basis for considering the
other than DeLuca were not based on As a result of the foregoing findings,
nature and extent of management Dr. Hargrave is debarred for 2 years from
any affirmative involvement in ordering participation as a factor in determining
the TRI-toxin or substituting the TRI- providing services in any capacity to a
the appropriateness and period of
toxin for BOTOX. Furthermore, in person with an approved or pending
debarment. FDA has relied on this factor
proposing to debar Dr. Hargrave for 4 drug product application under section
in other debarment cases where the
years, ORA did not rely on any findings 505, 512, or 802 of the FD&C Act (21
underlying conviction was of an
with respect to Dr. Hargrave’s intent or U.S.C. 355, 360b, or 382), or under
individual (see 78 FR 68455 (November
knowledge. Rather, citing the records of section 351 of the Public Health Service
14, 2013), 77 FR 27236–01 (May 9,
Dr. Hargrave’s criminal proceedings, the Act (42 U.S.C. 262), effective (see
2012)).
DATES), (see 21 U.S.C. 335a(c)(1)(B) and
proposal to debar simply rests on Dr. The limited scope of his direct actions
Hargrave’s position of authority within in committing the underlying (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
TPSG and his conduct in misbranding misdemeanor offense does not mitigate Any person with an approved, or
TRI-toxin by administering it to patients the extent of his management pending, drug product application, who
who believed they were receiving participation, as established during his knowingly uses the services of Dr.
BOTOX. As a result, under § 12.24(b), criminal proceedings and as set out in Hargrave, in any capacity during his
period of debarment, will be subject to
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there is no genuine and substantial issue the proposal to debar. It is true that
of fact raised by Dr. Hargrave’s nothing in the criminal proceedings or civil money penalties. If Dr. Hargrave,
arguments for resolution at a hearing. the proposal to debar reflects any during his period of debarment,
As set forth in the proposal to debar involvement by him in the decision to provides services in any capacity to a
and summarized previously, Dr. order the TRI-toxin and substitute it for 1 See United States v. Park, 421 U.S. 658, 673–
Hargrave pled guilty to a misdemeanor BOTOX, and the proposal to debar 74 (1975) (holding that a high-level manager within
under the FD&C Act for his role in specifically finds that another physician a business entity bears a responsibility to prevent
offering a drug under the name of authorized a nurse to place that order. and correct violations of the FD&C Act).
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![11998 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
person with an approved or pending considers your comment on this draft This guidance addresses the
drug product application he will be guidance before it begins work on the background considerations for
subject to civil money penalties. In final version of the guidance, submit determining the role of imaging in a
addition, FDA will not accept or review either electronic or written comments clinical trial as well as the major
any abbreviated new drug applications on the draft guidance by May 4, 2015. considerations in the development of an
submitted by or with the assistance of ADDRESSES: Submit written requests for
imaging charter that describes the trial’s
Dr. Hargrave during his period of single copies of the draft guidance to the imaging methods. The guidance
debarment. Division of Drug Information, Center for specifically addresses the technical
Any application by Dr. Hargrave for Drug Evaluation and Research, Food components of a charter’s description of
termination of debarment under section and Drug Administration, 10001 New the image acquisition, image
306(d) of the FD&C Act should be Hampshire Ave., Hillandale Bldg., 4th interpretation, and image data
identified with Docket No. FDA–2010– development methods.
Floor, Silver Spring, MD 20993–0002, or
N–0299 and sent to the Division of This draft guidance revises the draft
the Office of Communication, Outreach
Dockets Management (see ADDRESSES). guidance entitled ‘‘Standards for
and Development, Center for Biologics Clinical Trial Imaging Endpoints’’
All such submissions are to be filed in Evaluation and Research (CBER), Food
four copies. The public availability of issued on August 19, 2011 (76 FR
and Drug Administration, 10903 New 51993). Comments we received on the
information in these submissions is Hampshire Ave., Bldg. 71, Rm. 3128,
governed by 21 CFR 10.20(j). Publicly draft guidance have been considered
Silver Spring, MD 20993–0002. Send and the guidance has been revised as
available submissions may be seen in one self-addressed adhesive label to
the Division of Dockets Management follows: (1) It has been made clear that
assist that office in processing your the guidance pertains to imaging in
between 9 a.m. and 4 p.m., Monday requests. See the SUPPLEMENTARY
through Friday. Persons with access to clinical trials intended to support
INFORMATION section for electronic approval of drugs and biological
the Internet may obtain documents in access to the draft guidance document.
the Docket at http:// products and focuses upon standards
Submit electronic comments on the that FDA regards as important when
www.regulations.gov/.
draft guidance to http:// imaging is used to assess a trial’s
Dated: February 24, 2015. www.regulations.gov. Submit written primary endpoint; (2) it has been made
Stephen Ostroff, comments to the Division of Dockets clear that the imaging charter can be
Director, Office of the Chief Scientist. Management (HFA–305), Food and Drug either a single document or an ensemble
[FR Doc. 2015–05046 Filed 3–4–15; 8:45 am] Administration, 5630 Fishers Lane, Rm. of documents, depending on multiple
BILLING CODE 4164–01–P 1061, Rockville, MD 20852. factors; (3) it is emphasized that imaging
FOR FURTHER INFORMATION CONTACT: risks are best described in the clinical
Louis Marzella, Center for Drug protocol and should be addressed in
DEPARTMENT OF HEALTH AND Evaluation and Research, Food and consent documents instead of including
HUMAN SERVICES Drug Administration, 10903 New this information in the imaging charter;
Hampshire Ave., Bldg. 22, Rm. 5406, (4) it has been emphasized that this
Food and Drug Administration guidance does not address whether
Silver Spring, MD 20993–0002, 301–
[Docket No. FDA–2011–D–0586] 796–1414; or Stephen Ripley, Center for imaging outcomes are clinically
Biologics Evaluation and Research, meaningful and are acceptable for drug
Clinical Trial Imaging Endpoint Food and Drug Administration, 10903 approval evidence; (5) it has been noted
Process Standards; Draft Guidance for New Hampshire Ave., Bldg. 71, Rm. that image acquisition phantoms may or
Industry; Availability 7301, Silver Spring, MD 20993–0002, may not be necessary, depending on the
240–402–7911. nature of the imaging in a clinical trial;
AGENCY: Food and Drug Administration, (6) it has been modified to emphasize
HHS. SUPPLEMENTARY INFORMATION: the need for the clinical protocol (not
ACTION: Notice. I. Background the charter) to describe how incidental
findings will be handled; (7) it has been
SUMMARY: The Food and Drug FDA is announcing the availability of noted that the charter should identify
Administration (FDA) is announcing the a draft guidance for industry entitled any use of investigational equipment
availability of a draft guidance for ‘‘Clinical Trial Imaging Endpoint (for international trials, the guidance
industry entitled ‘‘Clinical Trial Imaging Process Standards.’’ The purpose of this encourages use of equipment that is
Endpoint Process Standards.’’ This guidance is to assist sponsors in lawfully marketed in the area); and (8)
guidance assists sponsors in optimizing optimizing the quality of imaging data a section has been added that describes
the quality of imaging data obtained in obtained in clinical trials intended to the importance of having the clinical
clinical trials intended to support support approval of drugs and biological trial sponsor ensure the fidelity of all
approval of drugs and biological products. It focuses on imaging charter components with the clinical
products. This guidance focuses on acquisition, display, archiving, and protocol.
imaging acquisition, display, archiving, interpretation standards that FDA This draft guidance is being issued
and interpretation process standards regards as important when imaging is consistent with FDA’s good guidance
that FDA regards as important when used to assess the trial’s primary practices regulation (21 CFR 10.115).
imaging is used to assess a trial’s endpoint or a component of that The draft guidance, when finalized, will
primary endpoint or a component of
mstockstill on DSK4VPTVN1PROD with NOTICES
endpoint. The guidance describes the represent the Agency’s current thinking
that endpoint. This draft guidance minimum standards a sponsor should on the major considerations for
revises the draft guidance entitled use to help ensure that clinical trial standardization of imaging primary
‘‘Standards for Clinical Trial Imaging imaging data are obtained in a manner endpoints in clinical trials of drugs and
Endpoints’’ issued on August 19, 2011. that complies with a trial’s protocol, biological products. It does not create or
DATES: Although you can comment on maintains imaging data quality, and confer any rights for or on any person
any guidance at any time (see 21 CFR provides a verifiable record of the and does not operate to bind FDA or the
10.115(g)(5)), to ensure that the Agency imaging process. public. An alternative approach may be
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Document Created: 2015-12-18 12:09:26
Document Modified: 2015-12-18 12:09:26
| 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 11995 |
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