been previously reviewed and approved by the FDA,
§ 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.
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
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