GAO Access to Trade Secret Information

GAO Access to Trade Secret Information

Section 301(j) of the Food, Drug, and Cosmetic Act of 1938 prohibits the Food and Drug Adm inis­
tration from providing the General Accounting Office with access to trade secret information sub­
mitted by drug manufacturers to the FDA.
September 13, 1988
M e m o r a n d u m O p in io n f o r t h e A c t in g G e n e r a l C o u n s e l
D e p a r t m e n t o f H e a l t h a n d H u m a n S e r v ic e s

This memorandum responds to your August 18, 1988, request for our opinion
as to whether the Food and Drug Administration (“FDA”) may provide the Gen­
eral Accounting Office (“GAO”) with access to trade secret information sub­
mitted by drug manufacturers pursuant to the Food, Drug, and Cosmetic Act of
1938 (“FDCA”), 21 U.S.C. §§ 301-393. For the reasons discussed below, we
concur with the conclusion of your office1 that section 30 l(j) of the FDCA, 21
U.S.C. § 33l(j), prohibits the FDA from providing the GAO with such access.
Section 301 (j) prohibits the FDA from
revealing, other than to the Secretary [of Health and Human Ser­
vices (HHS)] or officers or employees of [HHS], or to the courts
when relevant in any judicial proceeding under [the FDCA], any
information acquired under [specified sections of the FDCA] con­
cerning any method or process which as a trade secret is entitled
to protection.
Section 301 (j) is clear on its face. It expressly provides that trade secret infor­
mation may not be disclosed outside HHS with one exception: such information
may be disclosed to a court in a judicial proceeding under the FDCA. Since the
GAO is obviously not a court or part of HHS, under section 301 (j) it is prohib­
ited from gaining access to trade secret information.
Attorney General Griffin Bell previously interpreted section 301 (j) to preclude
the FDA from furnishing to a congressional committee trade secret information.
43 Op. Att’y Gen. No. 21, at 1-2 (Sept. 8,1978) (relying “on the unqualified lan­
guage of § 301 (j), the consistent and longstanding interpretation to this effect by
1 Letter for John O McGinnis, Deputy Assistant Attorney General, Office of Legal Counsel, from Robert P
Charrow, Deputy General Counsel, Department of Health and Human Services (Aug. 30, 1988).

181
[HHS], and prior congressional approval of that interpretation through the rejec­
tion of an amendment to create an express exemption permitting disclosures to
Congress”). The only question raised by your request, therefore, is whether the
GAO is precluded from access to trade secret information to the same extent as
congressional committees.
We have no hesitation in concluding, on the basis of the 1978 Attorney Gen­
eral Opinion, that section 301(j) should be interpreted to preclude the GAO from
access to trade secret information covered by that section. Although whether to
provide access to a congressional committee was the specific question presented,
the Attorney General Opinion discussed the application of section 301 (j) with re­
spect to Congress as a whole. The opinion noted that “[o]n its face, this section
imposes an absolute bar to disclosure of trade secret information outside [HHS],”
with the one exception of a judicial proceeding; the opinion declined to find “any
exception for disclosure to the Congress... to be implied.” Id. at 2. The Supreme
Court has held that the GAO is part of the legislative branch and is “subservient
to Congress.” Bowsher v. Synar, 478 U.S. 714, 727-32 (1986). It therefore fol­
lows that if there is no “exception for disclosure to the Congress,” as the Attor­
ney General Opinion concluded, then there is also no exception in section 301 (j)
for disclosure to the GAO.
You also raised in your request the question of whether 31 U.S.C. § 716(a) au­
thorizes the GAO to gain access to the trade secret information covered by sec­
tion 301(j). Section 716(a) provides that:
Each agency shall give the Comptroller General information the
Comptroller General requires about the duties, powers, activities,
organization, and financial transactions of the agency. The Comp­
troller General may inspect an agency record to get the informa­
tion. This subsection does not apply to expenditures made under
section 3524 or 3526(e) of this title.

Your office suggested, but after consideration dismissed, the argument that sec­
tion 716(a) supersedes section 301(j).
Under established rules of statutory construction concerning statutes that may
arguably conflict, however, section 301(j) controls in this situation. It is a cardi­
nal axiom of statutory construction that “[w]here there is no clear [congressional]
intention otherwise, a specific statute will not be controlled or nullified by a gen­
eral one, regardless of the priority of enactment.” Morton v. Mancari, 417 U.S.
535, 550-51 (1974); see also Busic v. United States, 446 U.S. 398, 406 (1980)
(“[A] more specific statute will be given precedence over a more general one, re­
gardless of their temporal sequence.”). Since section 30l(j) is a specific statute
directly addressing one executive branch agency’s handling of trade secret in­
formation, while section 716(a) is a general statute addressed to all kinds of in­
formation in possession of the executive branch, section 301(j) controls in the

182
absence of congressional intent to the contrary. We have reviewed the legislative
history of section 716(a) and have found no evidence of any such intent.2
Conclusion
For the foregoing reasons, we concur with your conclusion that section 301 (j)
of the FDCA prohibits the FDA from providing the GAO with access to trade se­
cret information submitted by drug manufacturers pursuant to the FDCA.
D o u g l a s W . K m ie c
Acting Assistant Attorney General
Office of Legal Counsel

2 The judicial enforcement provisions contained in other subsections of 31 U.S.C. § 716 do not provide any ba­
sis for concluding that section 716(a) supersedes section 301 (j). These other subsections set out a procedure by
which the GAO may seek judicial enforcement of its right to executive branch information under section 716(a).
See 31 U.S.C. § 7 16(b),(d) They also provide that certain types of information may be exempted from judicial en­
forcement. See 31 U.S.C. § 716(d). It might be argued on the basis of these other subsections that trade secret in­
formation must be provided to the GAO because it is not the kind of information that may be exempted from judi­
cial enforcement. This argument has no merit. It ignores the fundamental distinction between a nght and a judicial
remedy to enforce the right: these other subsections simply address a method of enforcing GAO's right to infor­
mation under section 716(a), they do not define in any way the nght itself. The question of the applicability of
GAO’s nght to information under section 716(a) is separate from, and does not depend on, any questions that may
arise under other subsections of 31 U.S.C. § 716 concerning judicial enforcement of that right.

183