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Drug Efficacy Study Implementation (DESI)
FDA’s administrative process to consider the effectiveness of drugs that had been approved only for
safety between 1938 and 1962 is called the drug efficacy study implementation (DESI).
Congress amended the Federal Food, Drug, and Cosmetic Act in 1962 to require that new drugs be
shown effective, as well as safe, to obtain FDA approval. The amendment required FDA to evaluate
the effectiveness of the drugs the agency had approved only for safety between 1938, when Congress
enacted the FD&C Act requiring new drugs be shown safe prior to marketing, and 1962.
Evaluation Procedure
FDA contracted with the National Academy of Sciences/National Research Council (NAS/NRC) to
make an initial evaluation of the effectiveness of more than 3,400 drugs that had been approved
only for safety between 1938 and 1962. The agency reviewed and reevaluated the NAS/NRC reports
and published its initial findings in Federal Register notices.
DESI covered the drugs reviewed by NAS/NRC, as well as the even larger number of drugs that
entered the market—without FDA approval—as identical, related or similar to those covered by
safety-only FDA approvals.
Final DESI Determinations
FDA’s final DESI determination classifies a drug as either effective for one or more of its labeled
indications or lacking substantial evidence of effectiveness for one or more of its labeled indications.
Most DESI proceedings have been closed and FDA’s findings have been published in the Federal
Register.
• If FDA’s final DESI determination classifies the drug as effective for one or more of its labeled
indications, the product can be marketed for those indications, provided it is the subject of an
application approved by FDA for safety and effectiveness. Medicines with a new drug
application (NDA) approved before 1962 only for safety require an approved supplement to
the original application if found to be effective under DESI. Drugs marketed as identical,
related or similar to a DESI drug that FDA classified as effective require either an approved
NDA or abbreviated new drug application (ANDA), as appropriate, to be marketed. After FDA
approves the application, the drug’s regulatory status is the same as any other drugs approved
by FDA for safety and efficacy and is no longer considered part of DESI.
• If FDA’s final DESI determination classifies a drug as lacking substantial evidence of
effectiveness, the agency will provide notice of an opportunity for a hearing. The agency
considers these requests and either grants or denies it. If a hearing request is denied or if no
hearing is requested, FDA publishes its final determination in the Federal Register
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withdrawing FDA approval due to lacking substantial evidence of effectiveness. Drugs
classified as lacking substantial evidence of effectiveness and those identical, related or similar
to it can no longer be marketed and are subject to enforcement action as unapproved new
drugs.
The New Drugs, Reports of Information for Drug Effectiveness (https://www.govinfo.gov/content/
pkg/FR-1966-07-09/pdf/FR-1966-07-09.pdf) Federal Register notice (July 9, 1966) provides
historical information.
Recent Final Decisions (updated April 2022)
DESI
number Title Docket Final agency decision
DESI Oral Prescription Drugs Containing FDA-1975- 87 Federal Register 24311 (https://
10837 an Anticholinergic or Antispasmodic N-0336 www.federalregister.gov/documents/
in Combination with a Sedative, and (Formerly 2022/04/25/2022-08740/drugs-for-human-
Single-Entity Antispasmodic Drug 75N-0184 use-drug-efficacy-study-implementation-
Products, in Oral Dosage Form oral-prescription-drugs-containing-an)
(April 25, 2022)
DESI Potassium Aminobenzoate Oral FDA–1977– 87 Federal Register 13294 (https://
7663 Preparations N–0015 www.govinfo.gov/content/pkg/
(Formerly FR-2022-03-09/pdf/2022-04971.pdf)
77N–0187) (March 9, 2022)
DESI Iodochlorhydroxyquin and FDA-1980- 85 Federal Register 42877 (https://
10367 Hydrocortisone, Vioform HC N-0038 www.govinfo.gov/content/pkg/
(formerly FR-2020-07-15/pdf/2020-15298.pdf) (July
80N-0012) 15, 2020)
DESI Peripheral Vasodilators, Vasodilan FDA-1984- 85 Federal Register 42882 (https://
6403 (Isoxsuprine) N-0259 www.govinfo.gov/content/pkg/
(formerly FR-2020-07-13/pdf/2020-15010.pdf) (July
84N-0167) 15, 2020)
(Part of) Pentaerythritol Tetranitrate (PETN) FDA-2020- 85 Federal Register 42002 (https://
DESI N-1253 www.govinfo.gov/content/pkg/
1786 FR-2020-07-13/pdf/2020-15010.pdf) (July
(formerly
13, 2020)
FDA-1987-
N-0054;
formerly
87N-0262)
Open DESI Proceedings
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A few DESI proceedings remain open without a final decision or resolution. It is the agency’s policy
that drugs subject to an open DESI proceeding may remain on the market during the proceedings.
DESI number Title Docket
(Part of) DESI Anticholinergic/Barbiturate Combinations (Donnatal) FDA-1975-
597 N-0336
(formerly
79N-0184)
(Part of) DESI Donnatal Extentabs FDA-1975-
597 N-0337
(formerly
75N-0223)
(Part of) DESI Oral Nitroglycerin, Extended Release FDA-1977-
1786 N-0356
(formerly
75N-0240)
DESI 5378 Amphetamines FDA-1979-
N-0328
(formerly
79N-0190)
DESI 7661 Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and FDA-1998-
Syntest H.S. tablets P-0083
(formerly
76N-0377)
DESI 8076 Benzocaine, Butyl Aminobenzoate (Butamben), and Tetracaine FDA-1975-
Hydrochloride Fixed Combination Drug Product; Cetacaine N-0338
(formerly
75N-0203)
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