[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42882-42883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1984-N-0259 (formerly 84N-0167)]


Vasodilan Injection and Tablets Containing Isoxsuprine 
Hydrochloride; Final Decision on Proposal To Withdraw Approval of New 
Drug Application; Availability of Final Decision

AGENCY: Food and Drug Administration; Health and Human Services (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), that Vasodilan containing Isoxsuprine Hydrochloride had not been 
shown to be supported by substantial evidence consisting of adequate 
and well-controlled studies to be effective for treating symptoms 
relating to senile dementia of the Alzheimer type (SDAT) and multiple 
infarct dementia and peripheral vascular disease, is the final decision 
of the Commissioner of Food and Drugs (the Commissioner).

DATES: This notice is applicable July 15, 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: Several parties to the hearing, including 
the new drug application (NDA) holder and identical, related, or 
similar (IRS) product manufacturers, filed exceptions to the ALJ's 
Initial Decision. FDA recently requested that the current owner of the 
NDA and successors-in-interest to IRS product manufacturers who 
submitted timely exceptions to the ALJ's Initial Decision affirm, 
within a specific timeframe, their interest in pursuing their appeals 
of the ALJ's Initial Decision. FDA did not receive any responses 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.

I. Background

    In 1962, 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 notice published in the Federal Register of July 11, 1972 (37 
FR 13565, available at https://www.govinfo.gov/content/pkg/FR-1972-07-11/pdf/FR-1972-07-11.pdf), after receiving reports from the National 
Academy of Sciences/National Research Council, Drug Efficacy Study 
Group, FDA stated that Vasodilan Injection and Tablets containing 
Isoxsuprine Hydrochloride lacked substantial evidence of effectiveness 
for several indications. In a notice published in the Federal Register 
of May 25, 1979 (44 FR 30443, available at https://www.govinfo.gov/content/pkg/FR-1979-05-25/pdf/FR-1979-05-25.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 
Vasodilan lacks substantial evidence of effectiveness for its labeled 
indications, and proposed to withdraw approval of the NDA and issued a 
notice of opportunity for hearing on a proposal to withdraw approval of 
Vasodilan.
    Mead Johnson, the NDA holder of Vasodilan (NDA 11-832) submitted 
data intended to support the effectiveness of Vasodilan for other 
indications, including: (1) Relief of symptoms associated with SDAT 
and/or multiple infarct dementia; (2) relief of symptoms associated 
with peripheral vascular disease of arteriosclerosis obliterans, 
thromboangiitis obliterans, and Raynaund's disease; and (3) relief of 
symptoms of uterine motility, including premature labor, dysmenorrhea, 
and threatened abortion.
    Mead Johnson and multiple IRS product manufacturers responded to 
the notice of opportunity for a hearing and submitted requests for a 
hearing. By notice published in the Federal Register on September 28, 
1984 (49 FR 38363, available at https://www.govinfo.gov/content/pkg/FR-1984-09-28/pdf/FR-1984-09-28.pdf), the Commissioner granted a hearing; 
however, the Commissioner only granted a hearing concerning the use of 
Vasodilan in treating symptoms related to: (1) SDAT or multiple infarct 
dementia and (2) peripheral vascular disease. Although Mead Johnson 
requested a hearing on the issue of Vasodilan's effectiveness in 
relieving symptoms of uterine motility, including premature labor, 
dysmenorrhea, and threatened abortion, Mead Johnson later abandoned 
this indication and consented to withdrawal of Vasodilan's approval for 
it (see id.). Following the submission of written testimony and 
documentary evidence, an ALJ, Daniel J. Davidson, conducted a hearing 
and issued his Initial Decision on August 20, 1986. The ALJ found that 
the effectiveness of Vasodilan had not been shown to be supported by 
substantial evidence and, as a result, ordered that the approval of the 
NDA be withdrawn. Mead Johnson and certain IRS product manufacturers 
timely appealed the ALJ's Initial Decision by filing exceptions with 
the Commissioner under 21 CFR 12.125.
    Separately, by notice published in the Federal Register of February 
11, 2009 (74 FR 6896), FDA withdrew approval of Vasodilan. The current 
NDA holder and successor to Mead Johnson, Apothecon, c/o Bristol-Myers 
Squibb Co. (BMS), had requested that FDA withdraw approval of the 
application because the drug product was no longer marketed; 
additionally, BMS waived its opportunity for a hearing on the 
withdrawal.
    On November 9, 2017, FDA sent letters to BMS and the successors-in-

[[Page 42883]]

interest to the IRS product manufacturers who submitted timely 
exceptions, to determine whether the companies remained interested in 
pursuing their appeals of the ALJ's Initial Decision. FDA informed the 
companies that, if they did not respond and affirm their desire to 
pursue their appeals by January 8, 2018, the Office of the Commissioner 
would conclude that the companies no longer wish to pursue the appeal 
of the ALJ's Initial Decision and will proceed as if the appeals have 
been withdrawn. The Office of the Commissioner did not receive a 
response from any of the companies 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)).
    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 Vasodilan will have the effect it purports or 
is represented to have under the conditions of use prescribed, 
recommended, or suggested in its labeling for: (1) SDAT or multiple 
infarct dementia and (2) peripheral vascular disease. 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 (see ADDRESSES).

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15248 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P


