Inspections, Compliance, Enforcement, and Criminal Investigations

12/21/1994

[Federal Register: November 29, 1994]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 92N-0457]

Arnold S. Mendell; Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Mr. Arnold S. Mendell, 500 Peconic St., Ronkonkoma, NY 11779, 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 Mr. Mendell was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. Mr. Mendell has failed to file with FDA information and analyses sufficient to create a basis for a hearing concerning this action

EFFECTIVE DATE: December 21, 1994

ADDRESSES: Application for termination of debarment to the Dockets

Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Tamar S. Nordenberg, Center for Drug Evaluation and Research (HFD-366), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION:

  1. Background

    Mr. Arnold Mendell, the former director of quality assurance of Bolar Pharmaceutical Co. (Bolar), pled guilty and was sentenced on December 13, 1991, for 2 counts of a 15-count indictment for Federal felony offenses under 21 U.S.C. 331(a) and 333(a)(2) and 18 U.S.C. 1505, for the introduction of adulterated drugs into interstate commerce with the intent to defraud, and for the obstruction of an FDA inspection of Bolar by producing false batch production and dissolution records for a Bolar product.

    In a certified letter received by Mr. Mendell on January 29, 1993, the Deputy Commissioner for Operations offered Mr. Mendell an opportunity for a hearing on the agency's proposal to issue an order under section 306(a) of the act debarring him from providing services in any capacity to a person that has an approved or pending drug product application. FDA based the proposal to debar Mr. Mendell on its finding that he was convicted of a felony under Federal law for conduct relating to the regulation of a drug product.

    The certified letter also informed Mr. Mendell that his request for a hearing could not rest upon mere allegations or denials, but it must present specific facts showing that there was a genuine and substantial issue of fact requiring a hearing. The letter also notified Mr. Mendell that if it conclusively appeared from the face of the information and factual analyses in his request for a hearing that there was no genuine and substantial issue of fact which precluded the order of debarment, FDA would enter summary judgment against him and deny his request for a hearing.

    In a letter dated February 25, 1993, Mr. Mendell requested a hearing, and in a letter dated March 15, 1993, Mr. Mendell submitted arguments and information in support of his hearing request. In his request for a hearing, Mr. Mendell did not dispute that he was convicted of felonies under Federal law as alleged by FDA. He argued, however, that the agency's proposal to debar him is unconstitutional because a retroactive application of the statute would violate the U.S. Constitution's prohibition against bills of attainder and ex post facto laws. He argued, also, that the debarment statute is overbroad and so denies him his due process.

    The Deputy Commissioner has considered Mr. Mendell's arguments and concludes that they are unpersuasive and fail to raise a genuine and substantial issue of fact requiring a hearing. The constitutional arguments that Mr. Mendell offers do not create a basis for a hearing because hearings are not granted on matters of policy or law, but only on genuine and substantial issues of fact (see 21 CFR 12.24(b)(1)). The arguments are, in any event, unconvincing, for the reasons discussed below.

  2. Mr. Mendell's Arguments in Support of a Hearing

    Mr. Mendell first argues that the ex post facto clause of the U.S. Constitution prohibits application of section 306(a)(2) of the act to him because this section was not in effect at the time of Mr. Mendell's criminal conduct. With the enactment of the Generic Drug Enforcement Act (GDEA) on May 13, 1992, Congress amended the Federal Food, Drug, and Cosmetic Act to include section 306(a)(2), and Mr. Mendell was convicted on December 13, 1991.

    An ex post facto law is one that reaches back to punish acts that occurred before enactment of the law or that adds a new punishment to one that was in effect when the crime was committed. (Ex Parte Garland, 4 Wall. 333, 377, 18 L. Ed. 366 (1866); Collins v. Youngblood, 110 S.Ct. 2715 (1990).)

    Mr. Mendell's claim that application of the mandatory debarment provisions of the act is prohibited by the ex post facto clause is unpersuasive. Because the intent behind debarment under section 306(a)(2) of the act is remedial rather than punitive, this section does not violate the ex post facto clause.

    The congressional intent with respect to actions under section 306(a)(2) of the act is clearly remedial. Congress created the GDEA in response to findings of fraud and corruption in the generic drug industry. Both the language of the GDEA itself and its legislative history reveal that the purpose of the debarment provisions set forth in the GDEA is ``to restore and ensure the integrity of the ANDA approval process and to protect the public health.'' (See section 1, Pub. L. 102-282, The Generic Drug Enforcement Act of 1992.) This is a remedial rather than a punitive goal. (See Manocchio v. Kusserow, 961 F.2d 1539, 1542 (11th Cir. 1992) (exclusion of physician from participation in medicare programs because of criminal conviction is remedial, not punitive).) Supporting the remedial character of debarment is a statement by Senator Hatch in the Congressional Record of April 10, 1992, at S 5616, ``* * * [t]he legislation * * * provides a much-needed remedy for the blatant fraud and corruption uncovered in the generic drug industry * * * during the last 3 years.''

    The Supreme Court has long held that statutes that deny future privileges to convicted offenders because of their previous criminal activities in order to ensure against corruption in specified areas do not impose penalties for past conduct and, therefore, do not violate the ex post facto law prohibitions. (See, e.g., Hawker v. New York, 170 U.S. 189, 190 (1898) (physician barred from practicing medicine for a prior felony conviction); DeVeau v. Braisted, 373 U.S. 154 (1960) (convicted felon's exclusion from employment as officer of waterfront union is not a violation of the ex post facto clause).)

    In DeVeau, the court upheld a law that prohibited a convicted felon's employment as an officer in a waterfront union. The purpose of the law was to remedy the past corruption and to ensure against future corruption in the waterfront unions. The Court in DeVeau, 363 U.S. at 160, stated:

    The question in each case where unpleasant consequences are brought to bear upon an individual for prior conduct, is whether the legislative aim was to punish that individual for past activity, or whether the restriction of the individual comes about as a relevant incident to a regulation of a present situation, such as the proper qualifications for a profession * * *.

    As in DeVeau, the legislative purpose of the relevant statute is to ensure that fraud and corruption are eliminated from the drug industry. The restrictions placed on individuals convicted of a felony under Federal law are not intended as punishment but are ``incident to a regulation of a present situation'' (DeVeau, 363 U.S. at 160) and necessary in order to remedy the past fraud and corruption in the industry.

    Mr. Mendell's bill of attainder argument is also unconvincing. A bill of attainder is a legislative act that inflicts punishment on named individuals or easily ascertainable members of a group without a judicial trial (United States v. Lovett, 328 U.S. 303 (1946)). As discussed previously, the legislative intent of the debarment statute is remedial, not punitive. Furthermore, the act is not specifically directed at Mr. Mendell individually, nor is it directed at easily ascertainable members of a group within the meaning of Lovett (supra).

    Mr. Mendell next argues that the law on which FDA bases its proposed debarment is unconstitutional because it is overly broad, stating that there is no rational connection between the GDEA and the accomplishment of a legitimate governmental goal. In fact, the debarment provisions at issue are narrowly drawn to accomplish the legitimate governmental purposes of ensuring the integrity of the drug regulatory process and protecting the public health (see Turner v. Safley, 482 U.S. 78, 89 (1987) (regulations valid if reasonably related to legitimate governmental interests)).

    In the interest of protecting the public welfare, section 306(c)(1)(B) of the act prohibits a debarred individual from ``providing services in any capacity to a person that has an approved or pending drug product application * * *.'' This language, which Mr. Mendell asserts is overly broad, is necessarily not more restrictive. An attempt to determine the particular positions which are closed to debarred persons would cause serious administrative difficulties, including the problems of (1) ascertaining the exact nature of the employee's relationship with the employer and of (2) determining what constitutes a sufficient nexus with the regulatory scheme under all circumstances. (See the House Committee on Agriculture's H. Rept. No. 1546, 87th Cong., 2d sess. 8 (1962), U.S. Code Cong. & Admin. News 1962, p. 2749, for Congress' explanation of similar expansive language in debarment provision of the Perishable Agricultural Commodities Act (PACA), discussed further below.)

    The United States Court of Appeals for the District of Columbia Circuit has recently upheld a comparable provision of PACA (7 U.S.C. sections 499a-499s), which bars certain persons implicated in wrongdoing under PACA from being employed by any person licensed under PACA, even in positions unrelated to that act's regulatory scheme. The court stated that the ``investigatory difficulty * * * confirms the reasonableness of Congress' amendment barring any employment for the proscribed period.'' (Siegel v. Lyng, 851 F.2d 412, 416 (D.C. Cir. 1988) (emphasis in original).)

    Mr. Mendell does not dispute the fact that he was convicted as alleged by FDA in its proposal to debar him, and he has raised no genuine and substantial issue of fact regarding this conviction. His legal arguments do not create a basis for a hearing and, in any event, are unpersuasive. Accordingly, the Interim Deputy Commissioner for Operations denies Mr. Mendell's request for a hearing.

  3. Findings and Order

    Therefore, the Interim Deputy Commissioner for Operations, under section 306(a) of the act, and under authority delegated to her (21 CFR 5.20), finds that Mr. Mendell has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product (21 U.S.C. 335a(a)(2)(B)).

    As a result of the foregoing findings, Mr. Arnold S. Mendell is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under section 505, 507, 512, or 802 of the act (21 U.S.C. 355, 357, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective December 21, 1994, (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(ee)).

    Any person with an approved or pending drug product application who knowingly uses the services of Mr. Mendell in any capacity, during his period of debarment, will be subject to civil money penalties. If Mr. Mendell, 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 application submitted by or with the assistance of Mr. Mendell during his period of debarment.

    Any application by Mr. Mendell for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 92N- 0457 and sent to the Dockets Management Branch (address above). 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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Dated: December 5, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-31250 Filed 12-20-94; 8:45 am]

BILLING CODE 4160-01-F

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