Opposition to Defense Motions re Due Process, Vagueness, "Van Liew", and
The defendant, XXXX X. XXXXX, has moved to strike or dismiss
portions of the Indictment, and for a bill of particulars. For the
reasons set forth in the following memorandum of law, the United
opposes those motions.|
The Indictment charges XXXX with conspiracy, obstruction of
administrative proceedings, and distributing adulterated drugs.
times relevant to the Indictment, XXXXX was vice-president for
assurance at the Prettybig Drug Company, and was responsible for
reports to the Food and Drug Administration ("FDA") concerning the
failure of marketed drug products to meet legally-required
specifications [NOTE: names changed from original]. XXXX also was
responsible for stopping the shipment of a drug, and initiating a
(if appropriate), when the drug failed to meet stability
See Indictment at 3. The Indictment charges that XXXXX
from FDA certain stability failures involving the prescription
Euthroid, Proloid, Parsidol, and Dilantin,[FN1] and that he caused
distribution in interstate commerce of adulterated Dilantin.
FN1. Euthroid and Proloid are thyroid medications,
is used to treat parkinsonism, and Dilantin is an anti-seizure
See Indictment ¶¶ 6-8.
A.Statutory And Regulatory Context
The Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C.
301 et seq., requires drug manufacturers to obtain approval
FDA prior to marketing prescription drugs. See 21 U.S.C.
355. Before granting a drug approval, scientists at FDA's
in Rockville, Maryland, undertake an extensive review of the drug's
formula and manufacturing processes, and of scientific evidence
establishing that the drug is safe and effective for use in the
recommended in its labeling. A manufacturer's "new drug
("NDA"), once approved by FDA, functions like a license, describing
particularly the manner in which the drug must be manufactured, and
specifications the drug must meet in order to be sold.
In addition, a precondition for FDA approval of any drug is
that the drug will be manufactured in conformity with "good
manufacturing practice" ("GMP"). Conformity with GMP is also a
requirement of the FDCA. The FDCA deems a drug to be
if . . . the methods used in, or the facilities or
used for, its manufacture, processing, packing, or holding do not
conform to or are not operated or administered in conformity with
current good manufacturing practice to assure that such drug meets
requirements of [the FDCA] as to safety and has the identity and
strength, and meets the quality and purity characteristics, which
purports or is represented to possess.
21 U.S.C. § 351(a)(2)(B). FDA has described certain
GMP in regulations set forth at 21 C.F.R. part 211.
FN2. The FDCA prohibits the interstate distribution of
adulterated drugs. 21 U.S.C. § 331(a).
An important aspect both of NDA approval and of GMP is drug
stability testing. See 21 C.F.R. §§ 211.137 and
As part of an NDA approval, FDA sets stability specifications
the ranges of acceptable potencies and/or dissolution
that a drug must meet at set time-intervals following production.
manufacturers conduct stability tests according to those
to ensure that a drug maintains its potency and dissolution
throughout its expiration period. For example, the NDA for Dilantin
mg requires that the product's dissolution characteristics be
6, 9, 12, 18, 24, and 36 months after manufacturing, to support a
three-year expiration period for the drug. The prescribed test
dissolving the drug in water, and measuring the rate of dissolution
assessing the amount of dissolution at 30 minutes, 60 minutes, and
FDA's role in ensuring drug safety and efficacy does not end
the agency has established specifications in an NDA. Pursuant to
statutory mandate, see 21 U.S.C. § 355(e) and (k), the
continuously monitors the drugs it has approved, to ensure that
safe and effective, and that they are not adulterated or
conducts this monitoring principally by reviewing required reports
manufacturers, see 21 C.F.R. § 314.81(b)(1) and (2), and
inspecting manufacturers' facilities. See 21 U.S.C. §
B. The Indictment
Count One of the Indictment ("the Conspiracy Count) charges
with conspiracy, under 18 U.S.C. § 371. As alleged, the
had three objects:
1. to violate Title 21, United States Code, Sections
331(a) and 333(a)(2), by introducing adulterated drugs into
commerce, with the intent to defraud and mislead;[FN3]
2. to violate Title 18, United States Code, Section
corruptly endeavoring to influence, obstruct, and impede the due
proper administration of the law under which a pending proceeding
being had before the Food and Drug Administration;
3. to defraud the United States, by using craft,
deceit, and dishonest means to impede, impair, obstruct, and defeat
lawful government functions of the FDA in its administration of the
Act and related regulations.
FN3. It is further alleged as a "manner and means of
conspiracy" that XXXXX and his co-conspirators, "knowing that
prescription drugs (including, but not limited to, Euthroid,
Parsidol, and Dilantin) had stability problems, caused Prettybig
continue to market those drugs and make profits without alerting
Counts Two through Four ("the Dilantin Counts") charge that
with the intent to defraud and mislead, caused the interstate
distribution of adulterated Dilantin, in violation of 21 U.S.C.
331(a). Count Five ("the Obstruction Count") alleges that XXXXX
obstructed FDA proceedings relating to three Dilantin drug
violation of 18 U.S.C. § 1505.
II. Counts One Through Four Of The Indictment Are
XXXXX contends that Counts One through Four of the
Conspiracy Count and the three Dilantin Counts--violate the
Due Process, and Double Jeopardy Clauses of the Fifth Amendment,
Notice Clause of the Sixth Amendment, and Rule 7(c) of the Federal
of Criminal Procedure. As demonstrated below, Counts One through
fully comply with all legal requirements relevant to the
In determining the legal sufficiency of an indictment, courts
guided by the following basic principles:
(1) the indictment must contain a statement of the
"essential facts constituting the offense charged," (2) it must
allegations of each element of the offense charged, so that the
defendant is given fair notice of the charge that he must defend,
(3) its allegations must be sufficiently distinctive so that an
acquittal or conviction on such charges can be pleaded to bar a
prosecution for the same offense.
United States v. Smith, 44 F.3d 1259, 1263 (4th Cir.)
Fed. R. Crim P. 7(c)(1)), cert. denied, 115 S. Ct. 1970
These criteria reflect the the several constitutional guarantees
XXXXX contends are violated in this case. See United
Darby, 37 F.3d 1059, 1063 (4th Cir. 1994), cert. denied,
S. Ct. 1826 (1995); United States v. Daniels, 973 F.2d 272,
(4th Cir. 1992), cert. denied, 506 U.S. 1086 (1993).
A. The Dilantin Counts Are Sufficient
The Dilantin Counts (Counts Two through Four) allege that
violated 21 U.S.C. § 331(a) by causing the shipment in
commerce of Dilantin that was adulterated because it was not
manufactured in conformity with GMP. The three counts are identical
all respects except for the dates of shipment.
"The allegations of an offense are generally sufficient if
in the words of the statute itself." Smith, 44 F.3d at 1264.
is the situation here: the language of the Dilantin Counts tracks
language of the relevant statutory and regulatory provisions that
describe the offenses--viz. 21 U.S.C. §§ 331(a),
333(a)(2), and 351(a)(2)(B); 21 C.F.R. § 211.100. Moreover,
count specifically describes the drug involved, the lot number of
drug, the date of shipment, the place to which the drug was
the manner in which the drug was adulterated. This is sufficient to
provide notice to XXXXX of the nature of the charges against him.
See, e.g., United States v. Bel-Mar Laboratories,
Inc., 284 F. Supp. 875, 884 (E.D.N.Y. 1968).
XXXXX complains that the Dilantin Counts "in no way apprise
of the conduct or omissions--by himself or anyone else--that
Lot #68400L of Dilantin criminally 'adulterated.'"[FN4] Def. Memo
4-5. The Dilantin Counts contain not only sufficient detail to
XXXXX of the theory of adulteration, but in fact provide more
than is legally required.
FNX. XXXXX's challenge to the sufficiency of the
Counts focuses exclusively on the adequacy of the allegation
adulteration. XXXXX also implies, however, that the mens rea of the
offenses is inadequately described. See Def. Memo at 3
that mental state of "intent to defraud and mislead" is "not
explained"). This suggestion is without merit. It has been clearly
that an indictment charging offenses under the FDCA need not allege
facts establishing the defendant's "intent to defraud and mislead."
See United States v. Arlen, 947 F.2d 139, 144-45 (5th
1991), cert. denied, 503 U.S. 939 (1992).
The theory of adulteration is clearly stated:
[the] drugs were adulterated within the meaning of the
Act, 21 U.S.C. § 351(a)(2)(B), in that the methods used in,
the facilities and controls used for, their manufacture,
packing, and holding did not conform to and were not operated and
administered in conformity with GMP, because the production
processes used to manufacture the drugs were inadequately designed
assure that the drugs met the requirements of the FD&C Act as to
and had the identity, strength, quality, and purity characteristics
which they purported to and were represented to possess.[FN5]
FN5. The language in the first underscored section
methods . . . with GMP,") tracks exactly the language of the FDCA's
requirement, 21 U.S.C. § 351(a)(2)(B). The second underscored
section ("the production . . . to possess.") tracks closely the
of an FDA GMP regulation, 21 C.F.R. § 211.100(a). Contrary to
XXXXX's assertion, Def. Memo at 12 n.8, the omission of a citation
this regulation is not ground for dismissal of the Dilantin
Counts. Fed. R. Crim. P. 7(c)(3).
Pursuant to this allegation, the government will prove at trial
Dilantin lot in question was adulterated because the process used
manufacture the drug was inadequate to assure that the drug would
its stability dissolution specifications.
XXXXX's contention that he cannot understand the nature of
charge sufficiently to prepare his defense is pure sophistry.
XXXXX acknowledges his clear understanding of the charge in a later
section of his memorandum, when he contends that the FDCA's GMP
requirement is unconstitutional as applied to this case. In that
context, he argues that "it was impossible in this case to predict
. . .
whether the particular process in question was 'inadequately'
'to assure' a particular result." Def. Memo at 30. This statement,
concisely describes the Indictment's stated theory of adulteration,
belies XXXXX's feigned confusion concerning the adulteration
XXXXX's complaint that "hopeless ambiguities" in the
will force him to "guess which of the 'methods' or 'facilities' or
'controls' were the source of the 'adulteration,'" Def. Memo at
also is without merit. The specific reason why the
processes for Dilantin 30 mg were inadequate to assure that the
would meet its stability specifications is not an "essential fact"
the government must prove to establish that the Dilantin was
adulterated; indeed, the government would be unable to make such
for even Prettybig Drug cannot answer the question. The government
prove, simply, that the processes Prettybig Drug used during times
relevant to the Indictment were inadequate. The Indictment
clearly apprises XXXXX of that allegation.
The sufficiency of the Dilantin Counts is further demonstrated
comparison with analogous indictments that have been upheld in
cases. Two particularly helpful examples can be found in United
States v. Smith, supra, and United States v.
F. Supp. 389, 394-96 (D. Md. 1991). Structurally, the charges in
cases--money laundering in Smith, false statements in
Lang--are very similar to the Dilantin Counts. The Dilantin
Counts allege interstate commerce involving drugs which
adulterated; that is, a core transaction (innocent by
that is made criminal because of the nature of the item
transacted. Similarly, the money laundering charges in
alleged a monetary transaction involving proceeds of a
fraud; and the false statement charges in Lang alleged
submission to a government agency of a document
Smith and Lang hold that an indictment charging
offenses of these sorts is sufficient if it provides details about
core transaction of the offense, but need not describe details of
nature of the item transacted. For example, the money laundering
in Smith stated no details of the wire fraud offense which
rendered the "monetary transaction" criminal. The Fourth Circuit
nonetheless held that the charge was sufficient:
The core of money laundering, which distinguishes
such offense from another, is the laundering transaction itself.
the requirement that the funds be illegally derived is not the
distinguishing aspect and therefore does not lie at the core of the
offense, details about the nature of the unlawful activity
the character of the proceeds need not be alleged.
Smith, 44 F.3d at 1265.
Lang reached a like result. In that case, the defendant
contended that an indictment charging submission of a false
the Securities and Exchange Commission was insufficient because it
not specify which parts of the documents were false, and why they
false. Judge Nickerson ruled that the charge was sufficient. "It is
submission of the false document which constitutes the separate
While some identification is required, it is not necessary that the
indictment itself go into evidentiary matters." Lang, 766 F.
Supp. at 396 (quoting United States v. Bernstein, 533 F.2d
786 (2d Cir.), cert. denied, 429 U.S. 998 (1976)).
As already noted, the "adulteration" allegation serves the
function for the Dilantin Counts as the wire fraud allegation
the money laundering charge in Smith, and allegation of
served for the false statements charge in Lang. Thus, as in
Smith and Lang, details concerning this component of
charge need not be pleaded. "Because the requirement that
[drugs] be [adulterated] is not the distinguishing aspect and
does not lie at the core of the offense, details about the
[adulteration] need not be alleged."[FN6] Smith, 44 F.3d at
Because they do describe the theory of adulteration, the Dilantin
are not merely sufficient, but they actually provide more
than legally is required.
FN6. In fact, as already explained, the Dilantin Counts
describe the theory of adulteration very specifically. Thus, the
Dilantin Counts actually provide greater specificity than
Van Liew v. United States, 321 F.2d 664 (5th Cir.
upon which XXXXX heavily relies, does not require a different
demonstrated below, Van Liew is distinguishable, both
and legally, from the instant case.
The defendants in Van Liew were charged by indictment
causing the "economic" adulteration and misbranding of orange juice
diluting the juice with water, sugar, and other ingredients.
at 667 and n.1. The Fifth Circuit held that the indictment violated
Fifth Amendment's Indictment Clause because it inadequately
the legal theories of adulteration and misbranding upon which the
jury had based the charges.
The indictment in Van Liew alleged that the orange
adulterated and misbranded "within the meaning of" certain
provisions of the FDCA (none of which is at issue in this case),
not explain further how those statutory provisions were violated.
view of the Fifth Circuit, this resulted in allegations of "a
unknown actions." Id. at 670. Whatever the merits of the
Circuit's ruling, it has no application to the Dilantin Counts. As
explained above, the Dilantin Counts specifically (and more than
adequately, under Fourth Circuit precedent) describe how the
was adulterated. The Dilantin Counts do not merely allege that the
Dilantin was adulterated "within the meaning of" the FDCA. Rather,
explain with particularity that the drug was adulterated because it
not manufactured in conformity with GMP, and further
nature of the non-conformity with GMP, tracking the language of the
applicable GMP regulation. Thus, Van Liew is wholly
Van Liew also is legally distinguishable, in that it
to conflict with precedent in the Fourth Circuit (and, indeed, has
received unfavorably by other courts, including within the Fifth
itself). Part of the reason XXXXX no doubt finds the Van
opinion appealing is its unusual emphasis on the Fifth Amendment's
Indictment Clause. Without question, indictment by a grand jury is
important constitutional guaranty. However, the government is
any other decision that has analytically isolated this guaranty in
manner the Fifth Circuit did in Van Liew.[FN7] Rather, as
Fourth Circuit has made clear, courts "ensure that a defendant is
afforded his constitutional guarantees under the [Indictment Clause
the] Fifth Amendment" by applying the three-part test quoted
from Smith. United States v. Darby, supra, 37
FN7. In United States v. Staggs, 881 F.2d 1527,
1533-34 & n.8 (10th Cir. 1989) (en banc), cert. denied, 493
1020 (1990), the court expressly rejected an analysis similar to
set forth in Van Liew.
The uniqueness of Van Liew, and its antagonism to
Circuit law, are evidenced by how Van Liew has fared in
statements cases similar to Lang. Whereas Lang holds
a false statements charge does not require specification of
particulars concerning falsity, Van Liew suggests that it
require such specification. Thus, for example, in United States
Winchester, 407 F. Supp. 261, 276 (D. Del. 1975), the court
that Van Liew supported a holding--inconsistent with
Lang--that an indictment must "spell out the specific
underlying the false statement charges."
Other courts, reaching results consistent with Lang,
expressly declined to follow Van Liew. In United States
Clark, 546 F.2d 1130 (5th Cir. 1977), for example, the Fifth
reached a result consistent with Lang, and all but overruled
Van Liew by interpreting the case as focusing on double
considerations, rather than on the grand jury guaranty.[FN8]
id. at 1134-35. Similarly, in United States v.
535 F.2d 556 (10th Cir.), cert. denied, 429 U.S. 820 (1976),
court reached a result consistent with Lang notwithstanding
acknowledgement that Van Liew would support an opposite
Id. at 564.
FN8. In other opinions, the Fifth Circuit has been
dismissive with respect to arguments based on Van Liew.
See, e.g., United States v. Graves, 669 F.2d
968 n.3 (5th Cir. 1982).
Van Liew thus clearly should have no impact on this
assessment of the validity of the Dilantin Counts. Van Liew
not only factually distinguishable from the instant case, but it
reflects a legal analysis (discredited in its own and other
that is irreconcilable with the law in the Fourth Circuit.
For the reasons stated above, the government therefore
that the Court deny XXXXX's motion to dismiss the Dilantin
B.The Conspiracy Count Is Sufficient
XXXXX next challenges that portion of the Conspiracy Count
charges him with conspiring "to violate Title 21, United States
Sections 331(a) and 333(a)(2), by introducing adulterated drugs
interstate commerce, with the intent to defraud and mislead."
at 4. XXXXX contends this allegation is insufficient because it
specify a theory of adulteration. Like XXXXX's challenge to the
Counts, this challenge also lacks merit.
If XXXXX is uncertain about the adulteration alleged in the
Conspiracy Count, that is only because he refuses to undertake a
reading of the Indictment. XXXXX overlooks entirely the allegation
it was "part of this conspiracy that the members of the conspiracy,
knowing that prescription drugs (including, but not limited to,
Euthroid, Proloid, Parsidol, and Dilantin) had stability problems,
caused Prettybig Drug to continue to market those drugs and make
without alerting FDA or consumers." Indictment at 5. It is clear
this allegation that XXXXX is charged with conspiring to ship drugs
were adulterated because they had stability problems.
Furthermore, as XXXXX recognizes, the only three overt acts of
Conspiracy Count that describe drug shipments refer to the same
drug shipments that are the basis for the Dilantin Counts. There
no doubt, then, that the Conspiracy Count charges XXXXX with
to commit the same offenses as are alleged in the Dilantin Counts.
Although XXXXX obviously understands this, he refuses to accept it,
insisting that the Conspiracy Count must stand alone. Def. Memo at
n.14. That is not the law in this Circuit, however. Rather, it has
expressly held that the allegations of related substantive counts
are relevant in determining the meaning and sufficiency of
conspiracy charge.[FN9] See United States v. Brown,
Supp. 322, 326 n.9 (E.D. Va. 1992) (citing United States v.
Duncan, 598 F.2d 839, 849 & n.5 (4th Cir.), cert.
U.S. 871 (1979)).
FN9. United States v. Hooker, 841 F.2d 1225 (4th
1988) (en banc), cited by XXXXX, holds only that a missing
element cannot be read from one count into a another (in the
absence of express incorporation). See id. at 1231.
Hooker does not prohibit reference to other counts to assist
understanding a charge (such as this one) which states all
elements. See United States v. Brown, 784 F. Supp.
324 n.6 (E.D. Va. 1992); see also United States v.
598 F.2d 839, 849 n.5 (4th Cir.), cert. denied, 444 U.S. 871
(1979) (allowing reference to other counts, noting "[w]e are not in
case, however, confronted with the complete omission of an
element of the offense, but at most a non-specific statement of an
element clearly identified"). Other circuits similarly allow that,
purposes of determining the sufficiency of one count in an
reference may be made to other counts. See, e.g.,
United States v. Morris, 18 F.3d 562, 568 (8th Cir. 1994);
United States v. Staggs, 881 F.2d 1527, 1531 (10th Cir.
banc), cert. denied, 493 U.S. 1020 (1990).
Like his challenge to the Dilantin Counts, XXXXX's complaint
the Conspiracy Count is overly technical, and inconsistent with the
applied in this Circuit.
It is well settled that in an indictment for
to commit an offense--in which the conspiracy is the gist of the
crime--it is not necessary to allege with technical precision all
elements essential to the commission of the offense which is the
of the conspiracy, . . . or to state such object with the detail
would be required in an indictment for committing the substantive
Wong Tai v. United States, 273 U.S. 77, 81 (1927) (citations
omitted); see also Belvin v. United States, 12 F.2d
550 (4th Cir.), cert. denied, 273 U.S. 706 (1926); United
States v. Brown, supra, 784 F. Supp. at 324. As noted
the Fourth Circuit's decision in Smith suggests that little,
any, detail concerning adulteration is necessary to state a
offense under 21 U.S.C. § 331(a). Under the more lenient
requirements applicable to object offenses of conspiracies,
the Conspiracy Count clearly is more than sufficient.
III.The FDCA's GMP Requirement Is Not
Vague As Applied
Complaining that the FDCA's GMP requirement is "too illusive
concept" upon which to rest criminal liability, Def. Memo at 10,
contends that the GMP requirement is vague as applied in this case.
Id. at 24-31. This challenge, too, has no merit.
XXXXX's claim that the GMP requirement is vague as applied
examined in the light of the facts of the case at hand." United
States v. McAusland, 979 F.2d 970, 975 (4th Cir. 1992) (quoting
United States v. Mazurie, 419 U.S. 544, 550 (1975)),
denied, 507 U.S. 1003 (1993). Here, the government will present
evidence that XXXXX was familiar with the GMP requirement from his
experience as a drug quality assurance officer at Prettybig Drug.
itself, this militates against any unfairness in holding XXXXX
responsible for shipping drugs that violated GMP. See
States v. Bel-Mar Laboratories, Inc., 284 F. Supp. 875, 883
(E.D.N.Y. 1968) (upholding GMP requirement against vagueness
and noting that the concept of GMP "is not strange to those in the
to whom [it] is directed").
Even more compellingly, the government's evidence will show
XXXXX was specifically aware that Dilantin 30 mg violated GMP, and
thus adulterated, in the manner alleged in the Indictment. Through
testimony and documentary evidence, the government will prove that
knew the Dilantin formulation was inadequate to produce a product
would consistently meet its stability specifications.[FN10] For
in a memorandum dated September 13, 1990, XXXXX wrote that "a
reformulation" of Dilantin 30 mg "is urgently needed" because of
risk of out-of-spec stability test results." Noting Prettybig
desire to continue marketing the product, XXXXX requested that
scientists work "to achieve a more consistent manufacturing
as soon as possible." Similarly, in a memorandum dated March 27,
XXXXX stated that reformulation was necessary "in order to meet
dissolution standards." [Copies of the two documents discussed
attached to this Memorandum.]
FN10. Stability specifications, which consist of
quantitative ranges, are the opposite of vague standards.
These statements are compelling proof that XXXXX knew the
formulation was inadequate to meet the product's specifications,
is precisely what the Indictment's adulteration theory alleges.
more, XXXXX knew that the inadequacies in the Dilantin formulation
created concern for the safety and efficacy of the drug, and thus
violated regulatory standards. In the March 27 memorandum, XXXXX
"Continuing with the status quo is not a viable option for a number
reasons, not the least of which is the potential for Class I recall
actions for any violation involving antiepileptics." As XXXXX
understood, FDA categorizes a recall as "Class I" when "there is a
reasonable probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences or death."
C.F.R. § 7.3(m)(1). Thus, XXXXX's acknowledgement of the risk
Dilantin would be the subject of a Class I recall evidences his
recognition that the inadequacies in the drug's formulation
GMP requirement that a drug's production processes must be adequate
assure the drug will meet its specifications.
XXXXX's vagueness challenge cannot survive this proof.
to vagueness under the Due Process Clause rest on the lack of
and hence may be overcome in any specific case where reasonable
would know that their conduct is at risk." Maynard v.
486 U.S. 356, 361 (1988); see also Boyce Motor Lines,
United States, 342 U.S. 337, 340 (1952) ("Nor is it unfair to
require that one who deliberately goes perilously close to an area
proscribed conduct shall take the risk that he may cross the
Here, before any of the Dilantin shipments referenced in the
Counts had occurred, XXXXX knew that the product violated
requirements and might therefore be the subject of a recall. This
conclusively refutes XXXXX's claim that the regulatory requirements
vague as applied to him.[FN11] See McAusland, 979
975-76; United States v. Ellen, 961 F.2d 462, 466-67 (4th
cert. denied, 506 U.S. 875 (1992).
FN11. The scienter the government will prove to convict
XXXXX of the Dilantin Counts--an intent to defraud or mislead--also
mitigates any vagueness in the GMP requirement. See
States v. Strauss, 999 F.2d 692, 698 (2d Cir. 1993); see
United States v. Hiland, 909 F.2d 1114, 1127 (8th Cir. 1990)
(scienter of FDCA offense protects defendant from being convicted
violating rules he didn't understand).
As XXXXX reluctantly acknowledges, Def. Memo at 30 n.22, a
consistent line of cases has upheld the GMP requirement against
of unconstitutional vagueness. See United States v.
Jamieson-McKames Pharmaceuticals, Inc., 651 F.2d 532, 545 n.24
Cir. 1981), cert. denied, 455 U.S. 1016 (1982); United
v. Article of Drug . . . "White Quadrisect", 484 F.2d 748 (7th
1973); United States v. The Kendall Company, 324 F. Supp.
629 (D. Mass. 1971); United States v. Bel-Mar Laboratories,
supra, 284 F. Supp. at 880-84. XXXXX offers no effective
challenge to these holdings. Rather, he simply ignores them,
in favor of a constitutional standard of definiteness that is much
stricter than settled doctrine permits.
The Constitution does not require perfect specificity in
statutes, but only a reasonable degree of certainty in light of the
[M]ost statutes must deal with untold and
variations in factual situations, and the practical necessities of
discharging the business of government inevitably limit the
with which legislators can spell out prohibitions. Consequently, no
than a reasonable degree of certainty can be demanded.
Boyce Motor Lines, Inc. v. United States, supra, 342
at 340. In the regulatory context, extra leeway is allowed because
the expectation that regulated entities will consult relevant
legislation in advance of action, and because such entities often
the opportunity to seek administrative clarification on important
statutory or regulatory issues. Village of Hoffman Estates v.
Flipside, Hoffman Estates, 455 U.S. 489, 498 (1982). This
interpretative flexibility is especially appropriate in the context
[T]he fact that the general public is unable
to protect itself in the purchase of food and drugs imposes a high
degree of responsibility on those who profit from their manufacture
sale and affects their obligations under regulatory legislation.
United States v. Marcen Laboratories, Inc., 416 F. Supp.
(S.D.N.Y.) (upholding FDCA definition of "new drug" against
challenge), aff'd, 556 F.2d 562 (2d Cir. 1976).
In Bel-Mar Laboratories, the court undertook a detailed
analysis of the constitutionality of the FDCA's GMP requirement.
Comparing the GMP statute with other FDCA provisions that have
vagueness attacks, the court found the GMP requirement "at least as
definite. . . ." 284 F. Supp. at 882. Moreover, the court noted:
The requisite conditions are not demanded in the
but rather are expressly related to the achievement of a specified
goal--the assurance that drugs will be safe and reliable. The fact
the standard may vary in degree does not render it
Id. at 882-83 (citations omitted). Bel-Mar is
and compelling precedent, which has been followed by several
See, e.g., United States v. Jamieson-McKames
Pharmaceuticals, Inc., supra, 651 F.2d at 545 n.24;
States v. The Kendall Company, supra, 324 F. Supp. at
far as government counsel is aware, moreover, no information or
indictment charging violations of GMP has ever been dismissed on
of unconstitutional vagueness.
For the foregoing reasons, XXXXX's vagueness attack against
Dilantin Counts and the portion of the Conspiracy Count which
the GMP requirement should be rejected.
IV.The Conspiracy Count Properly Alleges Both A
To Defraud And A Conspiracy To Commit Offenses
NOTE: The balance of this memorandum can be found in the Civil
Manual at 171Civil Resource Manual at
[updated June 1998]
[cited in USAM 4-8.240;
Civil Resource Manual 171]