MEMORANDUM OPINION
JAMES
E. BOASBERG UNITED STATES DISTRICT JUDGE
Those
drinking the contrast agent Vanilla SilQ before undergoing an
X-ray or other imaging procedure likely spend no time
pondering the central issue in this case: is this
barium-sulfate product a drug or is it a medical device?
Plaintiff
Genus Medical Technologies, LLC manufactures Vanilla SilQ
products - a line of contrast agents that are used to image
structures or fluids within the body. Defendant Federal Drug
Administration has authority to regulate medical products
like Genus's to assure their safety and efficacy. Under
the Federal Food, Drug, and Cosmetic Act (FDCA), the agency
can regulate products as, inter alia, drugs or
devices. The regulatory path the FDA chooses - that is,
whether it treats a product as a drug or a device -
implicates significantly different pre-market review and
post-market compliance requirements under the Act and
implementing regulations. Drugs are subject to a more
rigorous regimen, which costs its sponsor considerably more
money.
The FDA
here concluded that although the Vanilla SilQ products
appeared to qualify as devices under the FDCA, they were also
drugs and could be regulated accordingly. Plaintiff responded
with this suit, and the parties have now cross-moved for
summary judgment. Finding the agency's action to be
inconsistent with the Administrative Procedure Act and the
FDCA, the Court will grant Plaintiff's Motion for Summary
Judgment and deny the FDA's Cross-Motion.
I.
Background
To
provide context for the factual background, the Court first
sets out the statutory scheme.
A.
Statutory Framework
The
FDCA, 21 U.S.C. § 301 et seq., grants the FDA,
as the designee of the Secretary of Health and Human
Services, the authority to regulate medical products,
including “drugs” and “devices.”
Id. §§ 321(g)-(h), 393. The Act, in
relevant part, defines “drug” to include:
articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or other animals.
Id. § 321(g)(1). It defines
“device” in part, conversely, to mean:
an instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related
article, including any component, part, or accessory, which
is-- . . .
intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals, . . . and
which does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals
and which is not dependent upon being metabolized for the
achievement of its primary intended purposes.
Id. § 321(h).
Comparing
these definitions yields two conclusions that are relevant
here: first, all FDA-regulated diagnostic
“devices” meet the “drug” definition.
That is because of the overlap in the intended-use
portions of their definitions. Id. §§
321(g)(1), (h) (drugs and devices both include articles
“intended for use in the diagnosis” of disease).
Second, the critical difference between the two is that the
device definition includes two exclusionary clauses.
Specifically, a device, unlike a drug, neither achieves
“its primary intended purposes through chemical action
within or on the body of man” nor is “dependent
upon being metabolized for the achievement of its primary
intended purpose.” § 321(h); see also ECF
No. 17 (Joint Appendix (JA)) at FDA213 (FDA guidance refers
to these portions as “exclusionary clauses”).
1.
Regulatory Schemes
The
statutory distinctions between a drug and a device have
meaningful and practical consequences. For starters, the FDA
has established separate bureaucratic centers that oversee
the pre-market review and post-market regulation of drugs as
opposed to devices. The Center for Drug Evaluation and
Research (CDER) has primary jurisdiction over drugs, while
the Center for Devices and Radiological Health (CDRH) has
primary jurisdiction over medical devices. See 21
C.F.R. § 3.5; Intercenter Agreement Between the
Center for Drug Evaluation and Research and the Center for
Devices and Radiological Health, U.S. Food & Drug
Admin. (Oct. 31, 1991),
https://www.fda.gov/combination-products/classification-and-jurisdictional-information/intercenter-agreement-between-center-drug-evaluation-and-research-and-center-devices-and.
Each center has its own requirements for marketing
authorization.
To
market new prescription drugs, for example, a
sponsor - generally the manufacturer - must submit a new-drug
application demonstrating that the drug is safe and effective
for its proposed use. See 21 U.S.C. §
355(a)-(b). This process requires an extensive series of
safety and effectiveness trials before approval. Id.
§ 355(b). If the prospective drug is the “same
as” an existing drug already on the market, however,
the sponsor can obtain approval through the less onerous
abbreviated new-drug application process. Id. §
355(j). This abbreviated process requires proof that the drug
in question has the same active ingredients, effects, and
labeling as a predecessor drug that the FDA has already
approved. Id.; 21 C.F.R. § 314.94(a).
By
contrast, devices are reviewed and classified into
three categories based on the risk they pose to the public.
Class I devices are low risk - i.e., they
“present no unreasonable risk of illness or
injury” - and “are subject only to minimal
regulations by ‘general controls.'”
Medtronic, Inc. v. Lohr, 518 U.S. 470, 476-77 (1996)
(quoting 21 U.S.C. § 360c(a)(1)(A)). Class II devices
“are potentially more harmful”: “[A]lthough
they may be marketed without advance approval, manufacturers
of such devices must comply with federal performance
regulations known as ‘special controls.'”
Id. at 477 (quoting 21 U.S.C. § 360c(a)(1)(B)).
Lastly, high-risk devices are designated as Class III.
See 21 U.S.C. § 360c(a)(1)(C). To introduce a
new Class III device into the market, “the manufacturer
must provide the FDA with a ‘reasonable assurance'
that the device is both safe and effective.”
Medtronic, 518 U.S. at 477 (quoting 21 U.S.C. §
360e(d)(2)). To provide a “reasonable assurance,
” the manufacturer undergoes a pre-market approval
process, which requires “detailed information regarding
the safety and efficacy” of its device. Id.
Additionally,
significant cost differences exist in both the development
and the continued sale of drugs and devices. Plaintiff avers
that the cost of seeking clearance to market its products as
devices is estimated to be $60, 000, whereas seeking approval
to market them as drugs could be over half a million dollars
in addition to a continuing annual cost north of $186, 000.
See ECF No. 9 (Plaintiff's MSJ), Exh. 8
(Declaration of John E. Powers), ¶¶ 31-33.
2.
Requests ...