[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Notices]
[Pages 53507-53508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24806]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1981-N-0245 (Formerly 81N-0080)]


Mepergan Fortis Capsules; Final Decision on Proposal To Refuse 
Approval of Supplemental New Drug Application; Availability of Final 
Decision

AGENCY: Food and Drug Administration; HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing that the Initial Decision of the Administrative Law Judge 
(ALJ), to refuse approval of the supplemental new drug application 
(sNDA) for Mepergan Fortis Capsules (MFC) (meperidine HCl, promethazine 
HCl), is the final decision of the Commissioner by operation of law. In 
the Initial Decision, the ALJ found that MFC had not been shown to be 
supported by substantial evidence consisting of adequate and well-
controlled studies to be effective for sedation and analgesia in 
patients with concurrent moderate pain and apprehension, such as 
postoperative and post-trauma patients with those symptoms; that the 
drug did not satisfy the combination drug policy; and that it is a 
``new drug.'' The sNDA applicant filed exceptions to the ALJ's Initial 
Decision. FDA recently requested that the current owner of the sNDA 
application affirm its desire to pursue the appeal of the ALJ's Initial 
Decision; however, the applicant did not affirm its desire to pursue 
the appeal within the specified timeframe. Accordingly, FDA now deems 
those exceptions as withdrawn. Consequently, the proceeding is in the 
same procedural position as if no exceptions to the ALJ's Initial 
Decision had been filed; therefore, the ALJ's Initial Decision has 
become the final decision of the Commissioner by operation of law.

DATES: This final decision is effective November 16, 2017.

ADDRESSES: For access to the docket, go to https://www.regulations.gov 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday. Publicly 
available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of 
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.

SUPPLEMENTARY INFORMATION:

I. Background

    In 1962, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
was amended by the Drug Amendments Act of 1962, and these amendments 
provided that new drugs could no longer be approved unless both safety 
and efficacy had been established for them. As amended, the FD&C Act 
also required FDA to evaluate drugs approved as safe between 1938 and 
1962 to determine whether such drugs were effective and to withdraw 
approval for any new drug application (NDA) where there was not 
substantial evidence of the drug's effectiveness. The person contesting 
the withdrawal of the approval had the burden of coming forward with 
evidence of effectiveness for the drug. FDA's review of these pre-1962 
drugs is known as the Drug Efficacy Study Implementation (DESI) 
program.
    In a document published in the Federal Register of April 20, 1972 
(37 FR 7827), after evaluating reports received from the National 
Academy of Sciences/National Research Council, Drug Efficacy Study 
Group, and other available evidence, FDA classified MFC as ``possibly 
effective'' for moderate to moderately severe pain. This document also 
stated that no NDA had been approved or deemed approved for MFC and 
that additional evidence needed to be submitted to FDA to establish 
MFC's effectiveness. Thereafter, Wyeth, a division of American Home 
Products (Wyeth), submitted a supplement to its approved NDA 11-730 
(Mepergan Injection) for MFC (NDA 11-730, S-003). In a document 
published in the Federal Register of September 18, 1981 (46 FR 46404), 
the Director of the Bureau of Drugs (now the Center for Drug Evaluation 
and Research) proposed to refuse approval of the sNDA and offered Wyeth 
the opportunity for a hearing.
    Wyeth submitted its request for a hearing and, by a document 
published in the Federal Register of December 31, 1984 (49 FR 50788), 
the Office of the Commissioner granted the hearing request. Following 
the submission of written testimony and documentary evidence, an ALJ, 
Daniel J. Davidson, conducted a hearing from January 14 to 17, 1986. He 
issued his Initial Decision on December 4, 1987. The ALJ found that: 
(1) The effectiveness of MFC had not been proven by substantial 
evidence of adequate and well-controlled clinical trials, (2) the 
requirements of the combination drug policy had not been met, and (3) 
MFC is a new drug under 21 U.S.C. 321(p). Wyeth timely appealed the 
ALJ's Initial Decision by filing exceptions with the Commissioner under 
21 CFR 12.125.
    On August 23, 2017, FDA sent a letter to West-Ward Pharmaceuticals 
Corporation (West-Ward), successor to Wyeth, to determine whether West-
Ward remained interested in pursuing its appeal of the ALJ's Initial 
Decision. FDA informed the company that if it did not respond and 
affirm its desire to pursue its appeal by September 21, 2017, the 
Office of the Commissioner would conclude that West-Ward no longer 
wishes to pursue the appeal of the ALJ's Initial Decision and will 
proceed as if the appeal has been withdrawn. The Office of the 
Commissioner did not receive a response from West-Ward by the given 
date; therefore, the Commissioner now deems the exceptions withdrawn.

II. Conclusion and Order

    Given that the exceptions have been deemed withdrawn, this 
proceeding is now in the same procedural posture as if no exceptions 
had ever been filed. When parties do not file exceptions to the ALJ's 
Initial Decision, and the Commissioner does not file a notice of 
review, the ALJ's Initial Decision becomes the final decision of the 
Commissioner (see 21 CFR 12.120(e)). FDA will publish a notice in the 
Federal Register when an initial decision becomes the final decision of 
the Commissioner without appeal to or review by the Commissioner (see 
21 CFR 12.120(f)).
    Therefore, the ALJ's Initial Decision is the final decision of the 
Commissioner effective November 16, 2017. Pursuant to the findings in 
the ALJ's Initial Decision, under section 505(d) of the FD&C Act (21 
U.S.C. 355(d)) and under the authority delegated by the Secretary of 
Health and Human Services, the Commissioner finds that there is a lack 
of substantial evidence that MFC will have the effect it purports or is 
represented to have under the conditions of use prescribed,

[[Page 53508]]

recommended, or suggested in its labeling for sedation and analgesia in 
patients with concurrent moderate pain and apprehension, such as 
postoperative and post-trauma patients with those symptoms. The 
Commissioner further finds that MFC does not meet the combination drug 
policy in 21 CFR 300.50 and that it is a ``new drug'' within the 
meaning of 21 U.S.C. 321(p). Therefore, approval of the sNDA for MFC is 
denied. Distribution of products subject to the ALJ's Initial Decision 
in interstate commerce without an approved application is prohibited 
and subject to regulatory action (see, e.g., sections 505(a) and 301(d) 
(21 U.S.C. 331(d)) of the FD&C Act).
    The full text of the ALJ's Initial Decision may be seen in the 
Dockets Management Staff and in this docket (see ADDRESSES).

    Dated: November 7, 2017.
Denise Hinton,
Acting Chief Scientist.
[FR Doc. 2017-24806 Filed 11-15-17; 8:45 am]
 BILLING CODE 4164-01-P


