80 FR 11991 - Jeffrey L. Rockmore; 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 | 11991-11994 | |
| FR Document | 2015-05045 |
[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)] [Notices] [Pages 11991-11994] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05045] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0302] Jeffrey L. Rockmore; 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. Jeffrey L. Rockmore, and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Rockmore 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. Rockmore 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. Rockmore's debarment, FDA has considered the relevant factors listed in the FD&C Act. Dr. Rockmore 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. Rockmore, 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. Rockmore'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. Rockmore then proceeded to inject approximately 26 patients, who believed they were being injected with BOTOX, with TRI-toxin as a substitute. Dr. Rockmore 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. Rockmore dated November 30, 2010, [[Page 11992]] 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. Rockmore requested a hearing on the proposal. In his request for a hearing, Dr. Rockmore acknowledges his conviction under Federal law, as alleged by FDA. By letter dated January 28, 2011, Dr. Rockmore submitted materials and arguments in support of his request. Dr. Rockmore 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. Rockmore's arguments, as well as the proposal to debar itself, and concludes that, although Dr. Rockmore 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. Rockmore 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. Rockmore 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. Rockmore 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. Rockmore'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. Rockmore is, in fact, subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act. Dr. Rockmore 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. Rockmore, 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. Rockmore 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. Rockmore'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. Rockmore 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. Rockmore'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. Rockmore's offenses and the nature and extent of management participation were unfavorable factors with respect to him. Dr. Rockmore 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. Rockmore 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. Rockmore's criminal proceedings for its findings in the proposal to debar. There is nothing definitive in the criminal records before FDA to contradict Dr. Rockmore'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. Rockmore pled guilty alleges that TPSG, as opposed to Dr. Rockmore, began ordering TRI-toxin for use in the medical practice, and there are no allegations that Dr. Rockmore took part in the ordering process. Indeed, the proposal to debar states that, as claimed [[Page 11993]] by Dr. Rockmore, another physician in the practice, William F. DeLuca, Jr., was responsible for authorizing a nurse to substitute TRI-toxin for BOTOX, not Dr. Rockmore. At Dr. Rockmore'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. Rockmore'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. Rockmore 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. Rockmore for 4 years, ORA did not rely on any findings with respect to Dr. Rockmore's intent or knowledge. Rather, citing the records of Dr. Rockmore's criminal proceedings, the proposal to debar simply rests on Dr. Rockmore'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. Rockmore's arguments for resolution at a hearing. As set forth in the proposal to debar and summarized previously, Dr. Rockmore 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. Rockmore'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. Rockmore 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. Rockmore'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. Rockmore asserts that there was no management participation, and thus, this factor is inapplicable because the underlying conviction was of an individual. However, the criminal information to which Dr. Rockmore pled guilty alleges that TPSG began ordering TRI-toxin for use in the medical practice. It is undisputed that Dr. Rockmore 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. Rockmore, 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. Rockmore 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. Rockmore 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. Rockmore, 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. Rockmore 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. Rockmore 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. Rockmore, in any capacity during his period of debarment, will be subject to civil money penalties. If Dr. Rockmore, 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. Rockmore during his period of debarment. [[Page 11994]] Any application by Dr. Rockmore for termination of debarment under section 306(d) of the FD&C Act should be identified with Docket No. FDA-2010-N-0302 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. 2015-05045 Filed 3-4-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 11991
DEPARTMENT OF HEALTH AND Place: National Institutes of Health, 6701 In determining the appropriateness and
HUMAN SERVICES Rockledge Drive, Bethesda, MD 20892 period of Dr. Rockmore’s debarment,
(Virtual Meeting). FDA has considered the relevant factors
National Institutes of Health Contact Person: Olga A. Tjurmina, Ph.D., listed in the FD&C Act. Dr. Rockmore
Scientific Review Officer, Center for
Scientific Review, National Institutes of
has failed to file with the Agency
Center For Scientific Review; Notice of information and analyses sufficient to
Closed Meetings Health, 6701 Rockledge Drive, Room 4138,
MSC 7814, Bethesda, MD 20892, (301) 451– create a basis for a hearing concerning
Pursuant to section 10(d) of the 1375, ot3d@nih.gov. this action.
Federal Advisory Committee Act, as Name of Committee: Center for Scientific DATES: The order is effective March 5,
amended (5 U.S.C. App.), notice is Review Special Emphasis Panel; PAR–13– 2015.
hereby given of the following meetings. 009: Secondary Dataset Analyses in Heart, ADDRESSES: Submit applications for
The meetings will be closed to the Lung, and Blood Diseases and Sleep
Disorders.
termination of debarment to the
public in accordance with the Division of Dockets Management (HFA–
Date: March 26, 2015.
provisions set forth in sections Time: 8:00 a.m. to 6:00 p.m. 305), Food and Drug Administration,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Agenda: To review and evaluate grant 5630 Fishers Lane, Rm. 1061, Rockville,
as amended. The grant applications and applications. MD 20852.
the discussions could disclose Place: Melrose Georgetown Hotel, 2430 FOR FURTHER INFORMATION CONTACT:
confidential trade secrets or commercial Pennsylvania Avenue NW., Washington, DC Nathan Doty, Office of Scientific
property such as patentable material, 20037. Integrity, Food and Drug
and personal information concerning Contact Person: George Vogler, Ph.D.,
Administration, 10903 New Hampshire
individuals associated with the grant Scientific Review Officer, Center for
Scientific Review, National Institutes of
Ave., Silver Spring, MD 20993, 301–
applications, the disclosure of which 796–8556.
Health, 6701 Rockledge Drive, Room 3140,
would constitute a clearly unwarranted MSC 7770, Bethesda, MD 20892, (301) 237– SUPPLEMENTARY INFORMATION:
invasion of personal privacy. 2693, voglergp@csr.nih.gov.
I. Background
Name of Committee: Center for Scientific (Catalogue of Federal Domestic Assistance
Review Special Emphasis Panel; Member Program Nos. 93.306, Comparative Medicine; On August 11, 2009, in the U.S.
Conflict: Neurobiology of Addictions. 93.333, Clinical Research, 93.306, 93.333, District Court for the Northern District
Date: March 11, 2015. 93.337, 93.393–93.396, 93.837–93.844, of New York, Dr. Rockmore, a
Time: 11:30 a.m. to 12:30 p.m. 93.846-93.878, 93.892, 93.893, National physician, pled guilty to a misdemeanor
Agenda: To review and evaluate grant Institutes of Health, HHS) under the FD&C Act, namely
applications. misbranding a drug in violation of
Place: National Institutes of Health, 6701 Dated: February 25, 2015.
Rockledge Drive, Bethesda, MD 20892 Carolyn Baum, sections 301(k), 502(i)(3) and 303(a)(1)
(Telephone Conference Call). Program Analyst. Office of Federal Advisory of the FD&C Act (21 U.S.C. 331(k),
Contact Person: Boris P. Sokolov, Ph.D., Committee Policy. 352(i)(3), 333(a)(1)) and 18 U.S.C. 2. The
Scientific Review Officer, Center for [FR Doc. 2015–05005 Filed 3–4–15; 8:45 am] basis for this conviction was conduct
Scientific Review, National Institutes of
BILLING CODE 4140–01–P
surrounding his injection of patients
Health, 6701 Rockledge Drive, Room 5217A, seeking treatment with BOTOX/BOTOX
MSC 7846, Bethesda, MD 20892, 301–408– Cosmetic (BOTOX) with a product, TRI-
9115, bsokolov@csr.nih.gov. toxin, distributed by Toxin Research
This notice is being published less than 15 DEPARTMENT OF HEALTH AND
HUMAN SERVICES International, Inc. BOTOX is a
days prior to the meeting due to the timing
limitations imposed by the review and
biological product derived from
funding cycle. Food and Drug Administration Botulinum Toxin Type A that is
Name of Committee: Center for Scientific
manufactured by Allergan, Inc., and was
[Docket No. FDA–2010–N–0302]
Review Special Emphasis Panel; Member approved by FDA for use on humans for
Conflict: Neurobiology of Psychiatric Jeffrey L. Rockmore; Denial of the treatment of facial wrinkles in 1991.
Disorders. Hearing; Final Debarment Order According to the records of the criminal
Date: March 11, 2015. proceedings, Dr. Rockmore’s colleague
Time: 12:30 p.m. to 3:00 p.m. AGENCY: Food and Drug Administration, in the same medical practice, The
Agenda: To review and evaluate grant HHS. Plastic Surgery Group (TPSG), directed
applications. a nurse to obtain 31 vials of TRI-toxin,
Place: National Institutes of Health, 6701
ACTION: Notice.
an unapproved drug product, which
Rockledge Drive, Bethesda, MD 20892
SUMMARY: The Food and Drug was represented by its distributor as
(Telephone Conference Call).
Contact Person: Boris P. Sokolov, Ph.D.,
Administration (FDA) is denying a ‘‘Botulinum Toxin Type A’’. Dr.
Scientific Review Officer, Center for request for a hearing submitted by Dr. Rockmore then proceeded to inject
Scientific Review, National Institutes of Jeffrey L. Rockmore, and is issuing an approximately 26 patients, who
Health, 6701 Rockledge Drive, Room 5217A, order under the Federal Food, Drug, and believed they were being injected with
MSC 7846, Bethesda, MD 20892, 301–408– Cosmetic Act (FD&C Act) debarring Dr. BOTOX, with TRI-toxin as a substitute.
9115, bsokolov@csr.nih.gov. Rockmore for 2 years from providing Dr. Rockmore is subject to debarment
This notice is being published less than 15 services in any capacity to a person that based on a finding, under section
days prior to the meeting due to the timing has an approved or pending drug 306(b)(2)(B)(i)(I) of the FD&C Act (21
limitations imposed by the review and
mstockstill on DSK4VPTVN1PROD with NOTICES
product application. FDA bases this U.S.C. 335a(b)(2)(B)(i)(I)): (1) That he
funding cycle.
order on a finding that Dr. Rockmore was convicted of a misdemeanor under
Name of Committee: Center for Scientific was convicted of a misdemeanor under Federal law relating to the regulation of
Review Special Emphasis Panel; Member
Conflicts and Continuous Submissions.
Federal law for conduct relating to the a drug product under the FD&C Act and
Date: March 25, 2015. regulation of a drug product under the (2) that the type of conduct underlying
Time: 9:00 a.m. to 5:00 p.m. FD&C Act and that the type of conduct the conviction undermines the process
Agenda: To review and evaluate grant underlying the conviction undermines for the regulation of drugs. By notice to
applications. the process for the regulation of drugs. Dr. Rockmore dated November 30, 2010,
VerDate Sep<11>2014 19:28 Mar 04, 2015 Jkt 235001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\FR\FM\05MRN1.SGM 05MRN1](https://thefederalregister.org/doc/80_FR_12034/page/1.svg)
![11992 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
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. Rockmore’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. Rockmore 306(b)(2)(B)(i)(I). During his criminal guilty to misbranding TRI-toxin’’ and
requested a hearing on the proposal. In proceedings, Dr. Rockmore pled guilty ‘‘participated in the [TPSG’s] unlawful
his request for a hearing, Dr. Rockmore to 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. Rockmore 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 Rockmore’s offenses and the nature and
support of his request. Dr. Rockmore an approved drug product, BOTOX. Dr. extent of management participation
acknowledges that he was convicted of Rockmore’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. Rockmore counters ORA’s
should not be debarred for reasons be substituted for an approved drug findings with respect to those two
related to the factual basis set forth in without the knowledge of the patient. considerations in section 306(c)(3) of
the proposal to debar. In particular, with As a result, Dr. Rockmore is, in fact, the FD&C Act with the following
respect to the considerations for subject to debarment under section arguments: (1) That he did not admit
determining the appropriateness and 306(b)(2)(B)(i)(I) of the FD&C Act. any criminal intent or intentional
period of debarment under section Dr. Rockmore next challenges the wrongdoing when he pled guilty to a
306(c)(3) of the FD&C Act, he argues manner in which ORA applied the misdemeanor offense under the FD&C
that there are genuine and substantial considerations under section 306(c)(3) Act; (2) that, in fact, another physician
issues of fact for resolution at a hearing, of the FD&C Act in determining the at TPSG took unilateral action in
namely factual issues bearing on appropriateness and period of his ordering the TRI-toxin and directing a
whether he participated in or even knew debarment. In the proposal to debar Dr. nurse to substitute it for BOTOX; (3)
of certain conduct that resulted in his Rockmore, ORA stated that there are that the TRI-toxin vials that they used
violation of the FD&C Act. four applicable considerations under for injecting patients with TRI-toxin
Hearings are granted only if there is section 306(c)(3) of the FD&C Act: (1) were identical to the vials he used for
a genuine and substantial issue of fact. The nature and seriousness of his BOTOX before the substitution; and (4)
Hearings will not be granted on issues offense under section 306(c)(3)(A); (2) that since the conviction for the
of policy or law, on mere allegations, the nature and extent of management underlying misdemeanor was of an
denials, or general descriptions of participation in the offense under individual, that there was no
positions and contentions, or on data section 306(c)(3)(B); (3) the nature and management participation and that,
and information insufficient to justify extent of voluntary steps taken to thus, the nature and extent of
the factual determination urged or the mitigate the impact on the public under management participation is
action requested (see 21 CFR 12.24(b)). section 306(c)(3)(C); and (4) prior inapplicable as a factor in determining
The Chief Scientist has considered Dr. convictions involving matters within appropriateness and period of
Rockmore’s arguments, as well as the the jurisdiction of FDA under section debarment. Dr. Rockmore concedes that
proposal to debar itself, and concludes 306(c)(3)(F). ORA found with respect to he pled guilty to the misdemeanor
that, although Dr. Rockmore has failed Dr. Rockmore that the first two offense because he was, in fact, guilty of
to raise a genuine and substantial issue considerations weigh in favor of offering TRI-toxin for sale to their
of fact requiring a hearing, the debarment and noted that the third and patients as BOTOX. He argues, however,
appropriate period of debarment is 2 fourth considerations would be treated that the criminal records do not
years. as favorable factors for him. In making establish any intent or knowledge on his
all of its findings under section 306(c)(3) part and that thus the conduct
II. Arguments
of the FD&C Act, ORA characterized Dr. underlying his conviction does not
In support of his hearing request, Dr. warrant debarment in light of the
Rockmore first asserts that he is not Rockmore’s conduct based on records
from his criminal proceedings. considerations in section 306(c)(3) of
subject to debarment under section the FD&C Act.
Under section 306(c)(3)(A) of the
306(b)(2)(B)(i)(I) of the FD&C Act. He As noted previously, ORA relied on
FD&C Act, in determining the
contends that he pled guilty to a the records of Dr. Rockmore’s criminal
appropriateness and period of
misdemeanor violation of the FD&C Act proceedings for its findings in the
debarment, FDA considers ‘‘the nature
(see section 303(a)(1) of the FD&C Act), proposal to debar. There is nothing
and seriousness of the offense
which is a strict liability offense, and definitive in the criminal records before
involved.’’ In the proposal to debar,
that thus there was no demonstration or FDA to contradict Dr. Rockmore’s
ORA relied on the criminal information
admission of criminal intent or assertions with respect to the nature of
to which Dr. Rockmore pled guilty to
knowledge underlying the conviction. his involvement in the misdemeanor
find that the conduct underlying his
Dr. Rockmore concludes, therefore, that offense to which he pled guilty. The
convictions:
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the conduct underlying his conviction criminal information to which Dr.
did not undermine the process for the created a risk of injury to consumers due to Rockmore pled guilty alleges that TPSG,
regulation of drugs. the use of an unapproved drug, undermined as opposed to Dr. Rockmore, began
Section 306(b)(2)(B)(i)(I) of the FD&C [FDA’s] oversight of an approved drug
ordering TRI-toxin for use in the
product by representing that [he] used the
Act specifically provides for the approved drug while actually substituting an medical practice, and there are no
debarment of individuals convicted of unapproved drug in its place, and seriously allegations that Dr. Rockmore took part
Federal misdemeanors related to the undermined the integrity of [FDA’s] in the ordering process. Indeed, the
regulation of drug products under the regulation of drug products. proposal to debar states that, as claimed
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![Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 11993
by Dr. Rockmore, another physician in Rockmore’s offense did not rest on any management participation as an
the practice, William F. DeLuca, Jr., was intent or knowledge of wrongdoing on unfavorable factor.1
responsible for authorizing a nurse to his part, nor may such intent or Consistent with the proposal to debar,
substitute TRI-toxin for BOTOX, not Dr. knowledge be inferred from the the record establishes that the medical
Rockmore. At Dr. Rockmore’s circumstances of his offense or the practice of which Dr. Rockmore was a
sentencing hearing, at which six other findings in the proposal to debar. part ultimately took voluntary steps to
codefendants, including DeLuca, were Although, as a practicing physician, Dr. mitigate the effect on the public health
also sentenced, the presiding judge also Rockmore should be expected to take from its unlawful conduct (see section
made clear that he believed DeLuca was the appropriate steps to avoid 306(c)(3)(C) of the FD&C Act).
the physician responsible for making administering an unapproved new drug Furthermore, it is undisputed that Dr.
the ‘‘mistake’’ that led to the other to patients or misrepresenting the drug Rockmore had no previous criminal
physician’s offenses. In addressing being administered, his failure to do so convictions related to matters within the
DeLuca, the court stated: over a 10-month period does not jurisdiction of FDA (see section
And we’re here because of your actions and warrant considering the nature and 306(c)(3)(F) of the FD&C Act). Therefore,
inactions. As I said, your mistakes were seriousness of his offense as an these will be treated as favorable factors.
different in kind and degree from those of unfavorable factor, relative to the range In light of the foregoing four
your colleagues. It was you who brought this of conduct that might underlie a Federal considerations, one of which weighs
drug into the practice, and it was your misdemeanor conviction. against Dr. Rockmore, debarment for 2
conduct and your failure to check out either On the other hand, because of Dr.
the company or the drug that you were
years is appropriate.
Rockmore’s position of authority within
ordering, as you should have done, your III. Findings and Order
TPSG and, thus, presumed ability to
negligence in doing that that has brought us
here today in the end. prevent the series of events that resulted Therefore, the Chief Scientist, under
in the offense underlying his section 306(b)(2)(B)(i)(I) of the FD&C
In addressing one of the other three misdemeanor conviction, the nature and Act and under authority delegated to
physicians who pled guilty under extent of management participation in him, finds that Dr. Rockmore has been
circumstances similar to Dr. the offense is an unfavorable factor, for convicted of a misdemeanor under
Rockmore’s, the court further stated: the purposes of the consideration under Federal law for conduct relating to the
‘‘There have been disputes on how in 306(c)(3)(B) of the FD&C Act. Dr. development or approval of a drug
the past over who knew what and at Rockmore asserts that there was no product or otherwise relating to the
what point in time. It is clear from the management participation, and thus, regulation of a drug product under the
facts in this case that you had no this factor is inapplicable because the FD&C Act and that the conduct
knowledge that the substance was underlying conviction was of an underlying the conviction undermines
anything other than [BOTOX] until your individual. However, the criminal the regulation of drugs. FDA has
discovery of it in November of 2004.’’ information to which Dr. Rockmore pled
In short, consistent with the proposal considered the relevant factors listed in
guilty alleges that TPSG began ordering section 306(c)(3) of the FD&C Act and
to debar Dr. Rockmore for 4 years, the TRI-toxin for use in the medical
records of his criminal proceedings determined that a debarment of 2 years
practice. It is undisputed that Dr. is appropriate.
establish that the misdemeanor Rockmore is a principal in TPSG, and
convictions for the physicians in TPSG As a result of the foregoing findings,
this is the basis for considering the Dr. Rockmore is debarred for 2 years
other than DeLuca were not based on nature and extent of management
any affirmative involvement in ordering from providing services in any capacity
participation as a factor in determining to a person with an approved or
the TRI-toxin or substituting the TRI- the appropriateness and period of
toxin for BOTOX. Furthermore, in pending drug product application under
debarment. FDA has relied on this factor section 505, 512, or 802 of the FD&C Act
proposing to debar Dr. Rockmore for 4 in other debarment cases where the
years, ORA did not rely on any findings (21 U.S.C. 355, 360b, or 382), or under
underlying conviction was of an section 351 of the Public Health Service
with respect to Dr. Rockmore’s intent or individual (see 78 FR 68455 (November
knowledge. Rather, citing the records of Act (42 U.S.C. 262), effective (see
14, 2013); 77 FR 27236 (May 9, 2012)). DATES) (see 21 U.S.C. 335a(c)(1)(B) and
Dr. Rockmore’s criminal proceedings, The limited scope of his direct actions
the proposal to debar simply rests on Dr. (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
in committing the underlying
Rockmore’s position of authority within Any person with an approved, or
misdemeanor offense does not mitigate
TPSG and his conduct in misbranding pending, drug product application, who
the extent of his management
TRI-toxin by administering it to patients participation, as established during his knowingly uses the services of Dr.
who believed they were receiving criminal proceedings and as set out in Rockmore, in any capacity during his
BOTOX. As a result, under § 12.24(b), the proposal to debar. It is true that period of debarment, will be subject to
there is no genuine and substantial issue nothing in the criminal proceedings or civil money penalties. If Dr. Rockmore,
of fact raised by Dr. Rockmore’s the proposal to debar reflects any during his period of debarment,
arguments for resolution at a hearing. involvement by him in the decision to provides services in any capacity to a
As set forth in the proposal to debar order the TRI-toxin and substitute it for person with an approved or pending
and summarized previously, Dr. BOTOX, and the proposal to debar drug product application he will be
Rockmore pled guilty to a misdemeanor specifically finds that another physician subject to civil money penalties. In
under the FD&C Act for his role in authorized a nurse to place that order. addition, FDA will not accept or review
any abbreviated new drug applications
mstockstill on DSK4VPTVN1PROD with NOTICES
offering a drug under the name of However, Dr. Rockmore, as a principal
another. Based on the undisputed of TPSG, was responsible for failing to submitted by or with the assistance of
record before the Agency, the ensure that there were controls and Dr. Rockmore during his period of
consideration in section 306(c)(3)(A) of procedures in place to prevent other debarment.
the FD&C Act with respect to the nature physicians or a nurse from ordering 1 See United States v. Park, 421 U.S. 658, 673–
and seriousness of the offense involved unapproved drugs for administration to 74 (1975) (holding that a high-level manager within
is a favorable factor. As reflected in the patients. His own admitted inaction on a business entity bears a responsibility to prevent
records of the criminal proceedings, Dr. that front warrants treating his and correct violations of the FD&C Act).
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![11994 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
Any application by Dr. Rockmore for Estimation—Health Risks from Scientific Review, National Institutes of
termination of debarment under section Environmental Exposures; 93.142, NIEHS Health, 6701 Rockledge Drive, Room 5128,
306(d) of the FD&C Act should be Hazardous Waste Worker Health and Safety MSC 7840, Bethesda, MD 20892, 301–435–
Training; 93.143, NIEHS Superfund 1191, ipws@mail.nih.gov.
identified with Docket No. FDA–2010–
Hazardous Substances—Basic Research and Name of Committee: Center for Scientific
N–0302 and sent to the Division of Education; 93.894, Resources and Manpower Review Special Emphasis Panel; RFA ES–14–
Dockets Management (see ADDRESSES). Development in the Environmental Health 010: Centers of Excellence on Environmental
All such submissions are to be filed in Sciences; 93.113, Biological Response to Health Disparities Research.
four copies. The public availability of Environmental Health Hazards; 93.114, Date: March 30–April 1, 2015.
information in these submissions is Applied Toxicological Research and Testing, Time: 8:00 a.m. to 5:00 p.m.
governed by 21 CFR 10.20(j). Publicly National Institutes of Health, HHS) Agenda: To review and evaluate grant
available submissions may be seen in applications.
Dated: February 25, 2015.
the Division of Dockets Management Place: Ritz Carlton Hotel, 1150 22nd Street
Carolyn Baum, NW., Washington, DC 20037.
between 9 a.m. and 4 p.m., Monday Program Analyst, Office of Federal Advisory Contact Person: Wenchi Liang, Ph.D.,
through Friday. Persons with access to Committee Policy. Scientific Review Officer, Center for
the Internet may obtain documents in [FR Doc. 2015–05004 Filed 3–4–15; 8:45 am] Scientific Review, National Institutes of
the Docket at http:// Health, 6701 Rockledge Drive, Room 3150,
BILLING CODE 4140–01P
www.regulations.gov. MSC 7770, Bethesda, MD 20892, 301–435–
0681, liangw3@csr.nih.gov.
Dated: February 24, 2015.
Name of Committee: Center for Scientific
Stephen Ostroff, DEPARTMENT OF HEALTH AND Review Special Emphasis Panel; Program
Director, Office of the Chief Scientist. HUMAN SERVICES Project: ‘‘Cloud based Data Sharing and
[FR Doc. 2015–05045 Filed 3–4–15; 8:45 am] Analysis with Privacy Protection’’.
National Institutes of Health Date: March 30, 2015.
BILLING CODE 4164–01–P
Time: 1:00 p.m. to 4:00 p.m.
Center for Scientific Review; Notice of Agenda: To review and evaluate grant
Closed Meetings applications.
DEPARTMENT OF HEALTH AND Place: National Institutes of Health, 6701
HUMAN SERVICES Pursuant to section 10(d) of the Rockledge Drive, Bethesda, MD 20892,
Federal Advisory Committee Act, as (Virtual Meeting).
National Institutes of Health amended (5 U.S.C. App.), notice is Contact Person: Raymond Jacobson, Ph.D.,
hereby given of the following meetings. Scientific Review Officer, Center for
National Institute of Environmental The meetings will be closed to the Scientific Review, National Institutes of
Health Sciences; Notice of Closed public in accordance with the Health, 6701 Rockledge Drive, Room 5858,
Meeting provisions set forth in sections MSC 7849, Bethesda, MD 20892, 301–996–
7702, jacobsonrh@csr.nih.gov.
Pursuant to section 10(d) of the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and Name of Committee: Center for Scientific
Federal Advisory Committee Act, as Review Special Emphasis Panel; TW–14–003:
amended (5 U.S.C. App.), notice is the discussions could disclose Limited Competition: Research Training for
hereby given of the following meeting. confidential trade secrets or commercial Career Development of Junior Faculty in
The meeting will be closed to the property such as patentable material, Medical Education Partnership Initiative
public in accordance with the and personal information concerning (MEPI) Institutions.
provisions set forth in sections individuals associated with the grant Date: March 31, 2015.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications, the disclosure of which Time: 8:00 a.m. to 6:00 p.m.
would constitute a clearly unwarranted Agenda: To review and evaluate grant
as amended. The grant applications and applications.
the discussions could disclose invasion of personal privacy.
Place: Renaissance Mayflower Hotel, 1127
confidential trade secrets or commercial Name of Committee: Center for Scientific Connecticut Avenue NW., Washington, DC
property such as patentable material, Review Special Emphasis Panel; PAR–14– 20036.
and personal information concerning 317 and 318: Role of the Microbiome in HIV Contact Person: Hilary D. Sigmon, Ph.D.,
individuals associated with the grant Vaccine Responses. Scientific Review Officer, Center for
applications, the disclosure of which Date: March 18, 2015. Scientific Review, National Institutes of
would constitute a clearly unwarranted Time: 10:00 a.m. to 5:00 p.m. Health, 6701 Rockledge Drive, Room 5216,
Agenda: To review and evaluate grant MSC 7852, Bethesda, MD 20892, (301) 594–
invasion of personal privacy. applications. 6377, sigmonh@csr.nih.gov.
Name of Committee: National Institute of Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific
Environmental Health Sciences Special Rockledge Drive, Bethesda, MD 20892. Review Special Emphasis Panel; AIDS and
Emphasis Panel, International Collaborations Contact Person: Mary Clare Walker, Ph.D., AIDS Related Applications.
in Environmental Health. Scientific Review Officer, Center for Date: March 31, 2015.
Date: March 24–25, 2015. Scientific Review, National Institutes of Time: 8:00 a.m. to 6:00 p.m.
Time: 8:00 a.m. to 5:00 p.m. Health, 6701 Rockledge Drive, Room 5208, Agenda: To review and evaluate grant
Agenda: To review and evaluate grant MSC 7852, Bethesda, MD 20892, (301) 435– applications and/or proposals.
applications. 1165, walkermc@csr.nih.gov. Place: Hyatt Regency Bethesda, One
Place: NIEHS/National Institutes of Health, Name of Committee: Center for Scientific Bethesda Metro Center, 7400 Wisconsin
Keystone Building, 530 Davis Drive, Research Review Special Emphasis Panel; Special R01 Avenue, Bethesda, MD 20814.
Triangle Park, NC 27709, (Virtual Meeting). Review. Contact Person: Jingsheng Tuo, Ph.D.,
Contact Person: Sally Eckert-Tilotta, Ph.D., Date: March 25, 2015. Scientific Review Officer, Center for
mstockstill on DSK4VPTVN1PROD with NOTICES
Scientific Review Officer, National Institute Time: 3:00 p.m. to 5:00 p.m. Scientific Review, National Institutes of
of Environmental Health Sciences, Office of Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 5207,
Program Operations, Scientific Review applications. Bethesda, MD 20892, 301–451–8754, tuoj@
Branch, P.O. Box 12233, Research Triangle Place: National Institutes of Health, 6701 nei.nih.gov.
Park, NC 27709, (919) 541–1446, eckertt1@ Rockledge Drive, Bethesda, MD 20892, Name of Committee: Center for Scientific
niehs.nih.gov. (Telephone Conference Call). Review Special Emphasis Panel; PAR–14–
(Catalogue of Federal Domestic Assistance Contact Person: Wallace Ip, Ph.D., 280: Pilot Centers for Precision Disease
Program Nos. 93.115, Biometry and Risk Scientific Review Officer, Center for Modeling.
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Document Created: 2015-12-18 12:09:14
Document Modified: 2015-12-18 12:09:14
| 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 | |
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| 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 11991 |
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