[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42877-42879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15298]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1980-N-0038 (formerly 80N-0012)]
Vioform-Hydrocortisone Cream, Ointment, and Lotion Containing
Iodochlorhydroxyquin and Hydrocortisone; Final Decision on Proposal To
Withdraw Approval of New Drug Applications; Opportunity To Affirm
Outstanding Appeal
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 withdraw approval of the new drug application (NDA) for
Vioform-Hydrocortisone Cream, Ointment, and Lotion containing
Iodochlorhydroxyquin and Hydrocortisone (Vioform), is the final
decision of the Commissioner by operation of law. Several parties to
the hearing, including the NDA holder and identical, related, or
similar (IRS) product manufacturers, and a non-party participant timely
filed exceptions to the ALJ's Initial Decision. FDA recently requested
that the current owner of the NDA application, the IRS product
manufacturers, and the non-party participant that had timely filed
exceptions, or their successors-in-interest, affirm within a specific
timeframe their interest in pursuing their appeals of the ALJ's Initial
Decision. The NDA holder responded within the timeframe and withdrew
its appeal. No other appellants that received actual notice of the
Agency's request responded within the timeframe. Accordingly, FDA now
deems any exceptions filed by appellants that received notice of the
Agency's request to be withdrawn. FDA is, however, offering an
opportunity to other IRS product manufacturers, or successors-in-
interest, that submitted exceptions to the ALJ's Initial Decision and
did not receive notice of FDA's request, to affirm their desire to
pursue the appeal. The ALJ's Initial Decision is the final decision of
the Commissioner by operation of law; however, if FDA receives a valid
request to affirm the appeal, as described in this notice, we will
withdraw this notice.
DATES: This notice is applicable July 15, 2020. Any affirmation of
interest in pursuing an appeal should be submitted to the docket by
August 14, 2020.
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:
[[Page 42878]]
I. Background
The Federal Food, Drug, and Cosmetic Act (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 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 program.
In a document published in the Federal Register of June 20, 1972
(37 FR 12171, available at https://www.govinfo.gov/content/pkg/FR-1972-06-20/pdf/FR-1972-06-20.pdf), after receiving reports from the National
Academy of Sciences/National Research Council, Drug Efficacy Study
Group, and other available evidence, FDA classified Vioform as
``possibly effective'' for its labeled indications relating to use in
various dermatoses or as anti-infective agents. Thereafter, Ciba
Pharmaceutical Co., the NDA holder of Vioform (NDA 10-412) submitted
data intended to support the effectiveness of Vioform. In a document
published in the Federal Register of September 25, 1981 (46 FR 47408,
available at https://www.govinfo.gov/content/pkg/FR-1981-09-25/pdf/FR-1981-09-25.pdf), the Director of the Bureau of Drugs (now the Center
for Drug Evaluation and Research), after reviewing all the data
previously submitted, concluded that Vioform lacks substantial evidence
of effectiveness for its labeled indications and that the submitted
data do not demonstrate that each component of Vioform makes a
significant contribution to the claimed effects of the drug. Further,
the Director issued a notice of opportunity for hearing on a proposal
to withdraw approval of Vioform.
Ciba-Geigy Corporation (Ciba-Geigy) (formerly Ciba Pharmaceutical
Co.) and multiple IRS product manufacturers responded to the notice of
opportunity for hearing and submitted requests for hearing. By notice
published in the Federal Register of August 21, 1984 (49 FR 33173,
available at https://www.govinfo.gov/content/pkg/FR-1984-08-21/pdf/FR-1984-08-21.pdf), the Commissioner granted a hearing. Following the
submission of written testimony and documentary evidence, an ALJ,
Daniel J. Davidson, conducted a hearing, which concluded on December 4,
1985. He issued his Initial Decision on February 5, 1988. The ALJ
found: (1) That the effectiveness of Vioform had not been established
by substantial evidence of adequate and well-controlled studies, (2)
that the requirements of the combination drug policy had not been met,
and (3) that Vioform is a new drug under 21 U.S.C. 321(p). Ciba-Geigy,
the IRS product manufacturers, and one non-party participant timely
appealed the ALJ's Initial Decision by filing exceptions with the
Commissioner under Sec. 12.125 (21 CFR 12.125).
FDA recently sent letters to persons that submitted timely
exceptions or that FDA identified as successors-in-interest to parties
that submitted timely exceptions. The letters requested that the
persons that filed exceptions to the ALJ's Initial Decision, or their
successors-in-interest, affirm their intent to pursue their appeals and
informed them that, if they did not respond and affirm their desire to
pursue their appeal by a specified date, the Office of the Commissioner
would conclude that they no longer wish to pursue the appeal of the
ALJ's Initial Decision and would proceed as if the appeal has been
withdrawn. The Office of the Commissioner received a response from
Novartis, the current NDA holder and successor-in-interest to Ciba-
Geigy. In its letter, Novartis states that it does not wish to pursue
the appeal of the ALJ's Initial Decision. The letter also references a
previous request to withdraw the approval of the NDA for Vioform and
states that Novartis expects ``the NDA withdrawal in due course.''
The Office of the Commissioner also received a letter from Mr.
Edward John Allera (Mr. Allera) on behalf of an unidentified client on
October 23, 2017. In that letter, Mr. Allera stated that he represented
a client that was in the process of acquiring an interest in an IRS
product for which the original manufacturer filed timely exceptions.
Mr. Allera stated that he would like to affirm his client's intent to
pursue the other manufacturer's appeal of the ALJ's Initial Decision.
By letter dated December 21, 2017, Mr. Allera reaffirmed his client's
wish to pursue the appeal after acquiring an interest in the IRS
product. Mr. Allera's October 2017 letter made clear that, as of the
date specified to respond, his client neither had appealed the ALJ's
Initial Decision in this proceeding by timely filing exceptions nor
was, at that time, a successor-in-interest to a party that filed
exceptions. Only parties that submitted timely exceptions or were
actual successors-in-interest to parties that submitted timely
exceptions could affirm an interest in pursuing the appeal. See Sec.
12.125(a). Given that Mr. Allera's client met neither criterion, Mr.
Allera's client had no existing qualifying interest in pursuing the
appeal to affirm.
The Office of the Commissioner did not receive a response from any
IRS product manufacturers, or their successors-in-interest, that filed
timely exceptions to the ALJ's Initial Decision and that received
notice of the Agency's request to affirm their interest in pursuing
their appeals of the ALJ's Initial Decision. The deadlines for
responding to the Agency's requests have now passed. Therefore, the
Commissioner now deems the exceptions filed by appellants that received
notice of the Agency's requests to be withdrawn.
Despite FDA's efforts, based upon the responses to the recent
letters, FDA cannot eliminate the possibility that there might be
parties or successors-in-interest that filed timely exceptions but did
not receive FDA's letter. FDA is thus providing an opportunity for any
such person to affirm its interest in pursuing its appeal. The Agency
will only deem effective affirmations from persons that did not receive
a letter from FDA and that can establish: (1) That the person is a
party or a successor-in-interest to a party that submitted timely
exceptions and (2) that the person was a party or a successor-in-
interest during the time designated for it to respond to FDA's recent
letters. Any affirmation of interest in pursuing an appeal should be
submitted to the docket by (see DATES). The submission should include
documentation verifying that the person is a party or successor-in-
interest to a party that submitted timely exceptions and a statement
that the person wishes to pursue the appeal of the ALJ's Initial
Decision. FDA will withdraw this notice if we receive a timely
affirmation of interest and confirm that the person meets the requisite
criteria.
II. Conclusion and Order
Given that the exceptions have all been withdrawn or 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 Sec. 12.120(e) (21 CFR 12.120(e))). FDA will
publish a notice in the Federal Register when an initial decision
[[Page 42879]]
becomes the final decision of the Commissioner without appeal to or
review by the Commissioner (see Sec. 12.120(f)). Therefore, the ALJ's
Initial Decision is the final decision of the Commissioner effective 90
days after publication of this notice.
Pursuant to the findings in the ALJ's Initial Decision, under
section 505(e) of the FD&C Act (21 U.S.C. 355(e)), there is a lack of
substantial evidence that Vioform will have the effect it purports or
is represented to have under the conditions of use prescribed,
recommended, or suggested in its labeling for the treatment of primary
fungal infections or secondarily infected dermatoses. Further, Vioform
does not meet the combination drug policy in 21 CFR 300.50 and is a
``new drug'' within the meaning of 21 U.S.C. 321(p). Therefore,
approval of the NDA for Vioform is withdrawn October 13, 2020.
Distribution of products subject to the 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) of the FD&C
Act (21 U.S.C. 355(a) and 331(d)).
The full text of the ALJ's Initial Decision may be seen at Dockets
Management Staff (Ref. 1).
III. Reference
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov.
1. Initial Decision, Docket No. 80N-0012, ``Proposal to Withdraw
Approval of the New Drug Application for Vioform-Hydrocortisone
Cream, Ointment and Lotion Containing Iodochlorhydroxyquin and
Hydrocortisone under the Drug Efficacy Study Implementation
Program.''
Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15298 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P