Source: http://www.scribd.com/doc/87061440/Beaty-v-FDA-3-27-12-DCT-Memo
Timestamp: 2014-09-19 10:38:19
Document Index: 639909357

Matched Legal Cases: ['§ 331', '§ 352', '§ 353', '§ 355', '§ 314', '§ 801', '§321', '§ 360']

P. 1Beaty v FDA 3-27-12 DCT MemoBeaty v FDA 3-27-12 DCT MemoRatings: (0)|Views: 2,094
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M.D., in )
MEMO~M
(March2..1-, 2012) [#12 and #13]Plaintiffs, a group
death row inmates currently incarcerated in Arizona,California, and Tennessee, bring this action against the Food and Drug Administration("FDA"), the United States Department
Health and Human Services ("HHS"),Kathleen Sebelius in her official capacity as Secretary
ofHHS
"(Secretary"), and
Case 1:11-cv-00289-RJL Document 23 Filed 03/27/12 Page 1 of 23
Margaret A. Hamburg, M.D. in her official capacity as Commissioner
Food and Drugs("Commissioner") (collectively, "defendants"), alleging violations
the AdministrativeProcedure Act ("APA"), 5 U.S.C.
Specifically, plaintiffs allege thatdefendants violated provisions
("FDCA"
orthe "Act"),
by improperly allowing shipments
a misbrandedand unapproved new drug to enter the United States for use in state lethal injectionprotocols, which will be used during plaintiffs' executions. Before the Court areplaintiffs' Motion for Summary Judgment and Declaratory
on Counts I and III[Dkt. # 12] and defendants' Motion to Dismiss and/or for Summary Judgment [Dkt. #13].After careful consideration
the relevant law, the pleadings, and the entire recordherein, plaintiffs' motion is
and defendants' motion is DENIED.
has the authority to regulate the production and distribution
drugs inthe United States to promote public health and safety.
Pis.' Statement
UndisputedMaterial Facts in Supp.
("Pis.' SUMF"), Mar. 21. 2011,
I 2]. Under the FDCA, it is unlawful to introduce "misbranded" drugs into interstatecommerce. 2 I U.S.C. § 331(a). A drug
deemed misbranded if: (1) it was"manufactured, prepared, propagated, compounded, or processed in an establishment"not registered with the FDA,
352(0),
(2) it is not properly listed with theFDA,
§§ 352(0), 360U);
(3) its packaging does not display the symbol
§ 353(b)(4)(A).
is also unlawful to introduce a
drug"-a
drug that has not
Case 1:11-cv-00289-RJL Document 23 Filed 03/27/12 Page 2 of 23
been previously reviewed and approved by the FDA,
321(p)-into
§ 355(a). A
drug" must have an effective application that has beenapproved by the FDA.
application for a new drug must provide the
information sufficient to determine whether
used for its proposeduses, the drug is safe and effective, (2) the benefits
the drug outweigh any risks, and(3) the production and regulation methods
place can "ensure the [drug's] identity,strength, quality, and purity."
C.F.R. § 314.50 (2008); Mem. in SUpp.
PIs.'Mot. for Summ. J. ("PIs.' Mot. Mem."), Mar.
at 5 [Dkt.
12].The
has separate provisions concerning the distribution
domestic andforeign drugs.
381(a), (e). With respect to imports, as originallyenacted, the
the authority to inspect samples
imported drugs, butit did not impose an affirmative obligation on the FDA to do so.
No. 75-717,§ 801, 52 Stat. 1040, 1058 (1938) ("The Secretary
the Treasury shall deliver to theSecretary
upon his request,
food, drugs, devices, andcosmetics which are being imported or offered for import into the United States.")(emphasis added). In 1962, however, Congress amended the
in response to callsfor increased domestic and foreign drug regulation. PIs.' Mot. Mem. at
Pursuant tothe 1962 Amendments, Congress required any foreign establishment that manufactures,prepares, propagates, compounds, or processes a drug to be imported into the UnitedStates to both "immediately register" with the Secretary
ofHHS,
U.S.C. §§321(a)(2)(d), 360(i)(I)(A), and provide the Secretary with a list
all its imported drugsand devices,
§§ 360(i)(2), 360U). Also under the amended Act, the Secretary
Case 1:11-cv-00289-RJL Document 23 Filed 03/27/12 Page 3 of 23