82 FR 53507 - Mepergan Fortis Capsules; Final Decision on Proposal To Refuse Approval of Supplemental New Drug Application; Availability of Final Decision
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 220 (November 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 220 (November 16, 2017)
| Page Range | 53507-53508 | |
| FR Document | 2017-24806 |
[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)] [Notices] [Pages 53507-53508] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24806] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 Accordingly, FDA now deems those exceptions as withdrawn.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
![Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 53507
default.htm, or https:// insert the docket number, found in in the Federal Register of December 31,
www.regulations.gov. brackets in the heading of this 1984 (49 FR 50788), the Office of the
Dated: November 13, 2017. document, into the ‘‘Search’’ box and Commissioner granted the hearing
Anna K. Abram,
follow the prompts and/or go to the request. Following the submission of
Dockets Management Staff, 5630 Fishers written testimony and documentary
Deputy Commissioner for Policy, Planning,
Lane, Rm. 1061, Rockville, MD 20852 evidence, an ALJ, Daniel J. Davidson,
Legislation, and Analysis.
between 9 a.m. and 4 p.m., Monday conducted a hearing from January 14 to
[FR Doc. 2017–24831 Filed 11–15–17; 8:45 am]
through Friday. Publicly available 17, 1986. He issued his Initial Decision
BILLING CODE 4164–01–P
submissions may be seen in the docket. on December 4, 1987. The ALJ found
FOR FURTHER INFORMATION CONTACT: that: (1) The effectiveness of MFC had
Rachael Vieder Linowes, Office of not been proven by substantial evidence
DEPARTMENT OF HEALTH AND
Scientific Integrity, Food and Drug of adequate and well-controlled clinical
HUMAN SERVICES trials, (2) the requirements of the
Administration, 10903 New Hampshire
Food and Drug Administration Ave., Bldg. 1, Rm. 4206, Silver Spring, combination drug policy had not been
MD 20993, 240–402–5931. met, and (3) MFC is a new drug under
[Docket No. FDA–1981–N–0245 (Formerly 21 U.S.C. 321(p). Wyeth timely
81N–0080)] SUPPLEMENTARY INFORMATION:
appealed the ALJ’s Initial Decision by
I. Background filing exceptions with the Commissioner
Mepergan Fortis Capsules; Final under 21 CFR 12.125.
Decision on Proposal To Refuse In 1962, the Federal Food, Drug, and
On August 23, 2017, FDA sent a letter
Approval of Supplemental New Drug Cosmetic Act (the FD&C Act) was
to West-Ward Pharmaceuticals
Application; Availability of Final amended by the Drug Amendments Act
Corporation (West-Ward), successor to
Decision of 1962, and these amendments
Wyeth, to determine whether West-
provided that new drugs could no
AGENCY: Food and Drug Administration; Ward remained interested in pursuing
longer be approved unless both safety its appeal of the ALJ’s Initial Decision.
HHS. and efficacy had been established for FDA informed the company that if it did
ACTION: Notice. them. As amended, the FD&C Act also not respond and affirm its desire to
required FDA to evaluate drugs pursue its appeal by September 21,
SUMMARY: The Food and Drug approved as safe between 1938 and
Administration (FDA or the Agency) is 2017, the Office of the Commissioner
1962 to determine whether such drugs would conclude that West-Ward no
announcing that the Initial Decision of were effective and to withdraw approval
the Administrative Law Judge (ALJ), to longer wishes to pursue the appeal of
for any new drug application (NDA) the ALJ’s Initial Decision and will
refuse approval of the supplemental where there was not substantial
new drug application (sNDA) for proceed as if the appeal has been
evidence of the drug’s effectiveness. The withdrawn. The Office of the
Mepergan Fortis Capsules (MFC) person contesting the withdrawal of the
(meperidine HCl, promethazine HCl), is Commissioner did not receive a
approval had the burden of coming response from West-Ward by the given
the final decision of the Commissioner forward with evidence of effectiveness
by operation of law. In the Initial date; therefore, the Commissioner now
for the drug. FDA’s review of these pre- deems the exceptions withdrawn.
Decision, the ALJ found that MFC had 1962 drugs is known as the Drug
not been shown to be supported by Efficacy Study Implementation (DESI) II. Conclusion and Order
substantial evidence consisting of program. Given that the exceptions have been
adequate and well-controlled studies to In a document published in the deemed withdrawn, this proceeding is
be effective for sedation and analgesia in Federal Register of April 20, 1972 (37 now in the same procedural posture as
patients with concurrent moderate pain FR 7827), after evaluating reports if no exceptions had ever been filed.
and apprehension, such as received from the National Academy of When parties do not file exceptions to
postoperative and post-trauma patients Sciences/National Research Council, the ALJ’s Initial Decision, and the
with those symptoms; that the drug did Drug Efficacy Study Group, and other Commissioner does not file a notice of
not satisfy the combination drug policy; available evidence, FDA classified MFC review, the ALJ’s Initial Decision
and that it is a ‘‘new drug.’’ The sNDA as ‘‘possibly effective’’ for moderate to becomes the final decision of the
applicant filed exceptions to the ALJ’s moderately severe pain. This document Commissioner (see 21 CFR 12.120(e)).
Initial Decision. FDA recently requested also stated that no NDA had been FDA will publish a notice in the Federal
that the current owner of the sNDA approved or deemed approved for MFC Register when an initial decision
application affirm its desire to pursue and that additional evidence needed to becomes the final decision of the
the appeal of the ALJ’s Initial Decision; be submitted to FDA to establish MFC’s Commissioner without appeal to or
however, the applicant did not affirm its effectiveness. Thereafter, Wyeth, a review by the Commissioner (see 21
desire to pursue the appeal within the division of American Home Products CFR 12.120(f)).
specified timeframe. Accordingly, FDA (Wyeth), submitted a supplement to its Therefore, the ALJ’s Initial Decision is
now deems those exceptions as approved NDA 11–730 (Mepergan the final decision of the Commissioner
withdrawn. Consequently, the Injection) for MFC (NDA 11–730, S– effective November 16, 2017. Pursuant
proceeding is in the same procedural 003). In a document published in the to the findings in the ALJ’s Initial
position as if no exceptions to the ALJ’s
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register of September 18, 1981 Decision, under section 505(d) of the
Initial Decision had been filed; (46 FR 46404), the Director of the FD&C Act (21 U.S.C. 355(d)) and under
therefore, the ALJ’s Initial Decision has Bureau of Drugs (now the Center for the authority delegated by the Secretary
become the final decision of the Drug Evaluation and Research) of Health and Human Services, the
Commissioner by operation of law. proposed to refuse approval of the Commissioner finds that there is a lack
DATES: This final decision is effective sNDA and offered Wyeth the of substantial evidence that MFC will
November 16, 2017. opportunity for a hearing. have the effect it purports or is
ADDRESSES: For access to the docket, go Wyeth submitted its request for a represented to have under the
to https://www.regulations.gov and hearing and, by a document published conditions of use prescribed,
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![53508 Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices
recommended, or suggested in its Committees/AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers
labeling for sedation and analgesia in ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852.
patients with concurrent moderate pain FDA is establishing a docket for • For written/paper comments
and apprehension, such as public comment on this meeting. The submitted to the Dockets Management
postoperative and post-trauma patients docket number is FDA–2017–N–6292. Staff, FDA will post your comment, as
with those symptoms. The The docket will close on January 9, well as any attachments, except for
Commissioner further finds that MFC 2018. Submit either electronic or information submitted, marked and
does not meet the combination drug written comments on this public identified, as confidential, if submitted
policy in 21 CFR 300.50 and that it is meeting by January 9, 2018. Please note as detailed in ‘‘Instructions.’’
a ‘‘new drug’’ within the meaning of 21 that late, untimely filed comments will Instructions: All submissions received
U.S.C. 321(p). Therefore, approval of the not be considered. Electronic comments must include the Docket No. FDA–
sNDA for MFC is denied. Distribution of must be submitted on or before January 2017–N–6292 for ‘‘Bone, Reproductive
products subject to the ALJ’s Initial 9, 2018. The https://www.regulations. and Urologic Drugs Advisory
Decision in interstate commerce without gov electronic filing system will accept Committee; Notice of Meeting;
an approved application is prohibited comments until midnight Eastern Time Establishment of a Public Docket;
and subject to regulatory action (see, at the end of January 9, 2018. Comments Request for Comments.’’ Received
e.g., sections 505(a) and 301(d) (21 received by mail/hand delivery/courier comments, those filed in a timely
U.S.C. 331(d)) of the FD&C Act). (for written/paper submissions) will be manner (see ADDRESSES), will be placed
The full text of the ALJ’s Initial considered timely if they are in the docket and, except for those
Decision may be seen in the Dockets postmarked or the delivery service submitted as ‘‘Confidential
Management Staff and in this docket acceptance receipt is on or before that Submissions,’’ publicly viewable at
(see ADDRESSES). date. https://www.regulations.gov or at the
Dockets Management Staff between 9
Dated: November 7, 2017. Comments received on or before
a.m. and 4 p.m., Monday through
Denise Hinton, December 22, 2017, will be provided to
Friday.
Acting Chief Scientist. the committee. Comments received after • Confidential Submissions—To
that date will be taken into submit a comment with confidential
[FR Doc. 2017–24806 Filed 11–15–17; 8:45 am]
consideration by the Agency. information that you do not wish to be
BILLING CODE 4164–01–P
You may submit comments as made publicly available, submit your
follows: comments only as a written/paper
DEPARTMENT OF HEALTH AND Electronic Submissions submission. You should submit two
HUMAN SERVICES copies total. One copy will include the
Submit electronic comments in the information you claim to be confidential
Food and Drug Administration following way: with a heading or cover note that states
• Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
[Docket No. FDA–2017–N–6292]
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
Bone, Reproductive and Urologic instructions for submitting comments. Agency will review this copy, including
Drugs Advisory Committee; Notice of Comments submitted electronically, the claimed confidential information, in
Meeting; Establishment of a Public including attachments, to https://www. its consideration of comments. The
Docket; Request for Comments regulations.gov will be posted to the second copy, which will have the
docket unchanged. Because your claimed confidential information
AGENCY: Food and Drug Administration, comment will be made public, you are redacted/blacked out, will be available
HHS. solely responsible for ensuring that your for public viewing and posted on
ACTION: Notice; establishment of a comment does not include any https://www.regulations.gov. Submit
public docket; request for comments. confidential information that you or a both copies to the Dockets Management
third party may not wish to be posted, Staff. If you do not wish your name and
SUMMARY: The Food and Drug such as medical information, your or contact information to be made publicly
Administration (FDA or Agency) anyone else’s Social Security number, or available, you can provide this
announces a forthcoming public confidential business information, such information on the cover sheet and not
advisory committee meeting of the as a manufacturing process. Please note in the body of your comments and you
Bone, Reproductive and Urologic Drugs that if you include your name, contact must identify this information as
Advisory Committee. The general information, or other information that ‘‘confidential.’’ Any information marked
function of the committee is to provide identifies you in the body of your as ‘‘confidential’’ will not be disclosed
advice and recommendations to the comments, that information will be except in accordance with 21 CFR 10.20
Agency on FDA’s regulatory issues. The posted on https://www.regulations.gov. and other applicable disclosure law. For
meeting will be open to the public. FDA • If you want to submit a comment more information about FDA’s posting
is establishing a docket for public with confidential information that you of comments to public dockets, see 80
comment on this document. do not wish to be made available to the FR 56469, September 18, 2015, or access
DATES: The meeting will be held on public, submit the comment as a the information at: https://www.gpo.gov/
January 10, 2018, from 8 a.m. to 5 p.m. written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ADDRESSES: College Park Marriott Hotel manner detailed (see ‘‘Written/Paper 23389.pdf.
and Conference Center, Chesapeake Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Ballroom, 3501 University Blvd. East, read background documents or the
Written/Paper Submissions
Hyattsville, MD 20783. The conference electronic and written/paper comments
center’s telephone number is 301–985– Submit written/paper submissions as received, go to https://www.regulations.
7300. Answers to commonly asked follows: gov and insert the docket number, found
questions about FDA Advisory • Mail/Hand delivery/Courier (for in brackets in the heading of this
Committee meetings may be accessed at: written/paper submissions): Dockets document, into the ‘‘Search’’ box and
https://www.fda.gov/Advisory Management Staff (HFA–305), Food and follow the prompts and/or go to the
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Document Created: 2017-11-16 03:53:29
Document Modified: 2017-11-16 03:53:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | This final decision is effective November 16, 2017. | |
| 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. | |
| FR Citation | 82 FR 53507 |
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