[Federal Register Volume 59, Number 44 (Monday, March 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5130]


[[Page Unknown]]

[Federal Register: March 7, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0006]

 

Proposed Switch of Acyclovir from Prescription to Over-the-
Counter Status; Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing regarding the proposed over-the-counter (OTC) availability of 
orally administered acyclovir. The purpose of the hearing is to solicit 
information from, and the views of, interested persons, including 
scientists, professional groups, and consumers, on the issues and 
concerns relating to the proposed OTC availability of acyclovir for the 
acute and suppressive management of recurrent genital herpes.

DATES: The public hearing will be held on Thursday, May 19, 1994, from 
8 a.m. to 3 p.m. Submit written notices of participation and comments 
by April 29, 1994. Written comments will be accepted until June 20, 
1994.

ADDRESSES: The public hearing will be held at the Parklawn Bldg., 
conference rms. D and E, 5600 Fishers Lane, Rockville, MD 20857. Submit 
written notices of participation and comments to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 
Parklawn Dr., Rockville, MD 20857. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with docket number 94N-0006. Transcripts of the hearing 
will be available for review at the Dockets Management Branch (address 
above).

 FOR FURTHER INFORMATION CONTACT: Lee L. Zwanziger, Center for Drug 
Evaluation and Research (HFD-9), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-4695.

I. Background

 SUPPLEMENTARY INFORMATION: Acyclovir is a synthetic purine nucleoside 
analogue with in vitro inhibitory activity against herpes simplex 
viruses 1 and 2 and varicella zoster virus. An oral formulation of 
acyclovir was approved in 1985 with initial indications for the 
treatment of first episode and recurrent genital herpes. Since 1985, 
FDA has also approved the oral formulation of acyclovir for the 
treatment of herpes zoster and chickenpox, and for the suppression of 
recurrent genital herpes.
     Burroughs-Wellcome has discussed publicly its intention to seek 
approval for a supplemental new drug application (NDA) to switch 
acyclovir from prescription to OTC status (e.g., at the July 1993 
International Herpesvirus Workshop). Burroughs-Wellcome has also 
discussed publicly that this application is currently under review at 
FDA (e.g., at the October 1993 Interscience Conference on Antimicrobial 
Agents and Chemotherapy).
     The proposed switch would apply only to 200-milligram capsules 
with proposed indications for the acute and suppressive management of 
recurrent genital herpes. If the supplemental NDA is approved, 
acyclovir would be the first systemically administered antimicrobial 
agent available without prescription in the United States, and it would 
also be the first OTC product for the treatment of a sexually 
transmitted disease.

II. Scope of the Hearing

     In light of the many complex scientific and public health issues 
raised by this application, FDA is soliciting broad public 
participation and comment on the potential merits and disadvantages of 
this proposed switch. The agency encourages investigators with 
information relevant to this switch, as well as other interested 
persons, to respond to this notice. Examples of issues that are of 
interest to the agency include the following: (1) The implications of 
unrestricted availability of acyclovir for the transmission and 
asymptomatic shedding of herpes simplex virus; (2) the incidence and 
clinical significance of acyclovir-resistant herpes simplex virus; (3) 
the ability of patients to self-diagnose genital herpes (i.e., without 
consultation with a physician); (4) the potential for misuse for 
unapproved OTC indications (such as for chickenpox, shingles, and other 
viral illnesses); (5) the potential for adverse effects on the fetus; 
and (6) general issues of safety (and the incidence of adverse drug 
events) during widespread, unrestricted use. In addition, FDA is 
actively seeking the views of professional and consumer groups 
regarding the implications of this application for their constituent 
populations.
     Elsewhere in this issue of the Federal Register, FDA is announcing 
a joint meeting of the Antiviral and the Nonprescription Drugs Advisory 
Committees under 21 CFR part 14. This meeting will allow FDA to receive 
comments from the advisory committee members as well as the general 
public. Those persons or groups presenting views at the public hearing 
before the Commissioner need not make a second presentation at the 
advisory committee meeting, because views presented in the earlier 
hearing will be taken into consideration in the joint advisory 
committee meeting.

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with 21 CFR part 15. The presiding 
officer will be the Commissioner of Food and Drugs or his designee. The 
presiding officer will be accompanied by a panel of Public Health 
Service employees with the relevant expertise.
     Persons who wish to participate in the part 15 hearing must file a 
written notice of participation with the Dockets Management Branch 
(address above) prior to April 29, 1994. To ensure timely handling, any 
outer envelope should be clearly marked with the docket number 94N-0006 
and the statement ``Acyclovir Hearing.'' Groups should submit two 
copies. The notice of participation should contain the person's name, 
address, telephone number, affiliation if any, brief summary of the 
presentation, and approximate amount of time requested for the 
presentation. The agency requests that interested persons and groups 
having similar interests consolidate their comments and present them 
through a single representative. FDA will allocate the time available 
for the hearing among the persons who file notices of participation as 
described above. If time permits, FDA may allow interested persons 
attending the hearing who did not submit a written notice of 
participation, in advance, to make an oral presentation at the 
conclusion of the hearing.
     After reviewing the notices of participation and accompanying 
information, FDA will schedule each appearance and notify each 
participant by telephone of the time allotted to the person and the 
approximate time the person's oral presentation is scheduled to begin. 
The hearing schedule will be available at the hearing. After the 
hearing, it will be placed on file in the Dockets Management Branch 
under the docket number 94N-0006.
    Under Sec. 15.30 the hearing is informal, and the rules of evidence 
do not apply. No participant may interrupt the presentation of another 
participant. Only the presiding officer and panel members may question 
any person during or at the conclusion of their presentation.
     Public hearings, including hearings under part 15, are subject to 
FDA's guideline (21 CFR part 10, Subpart C) concerning the policy and 
procedures for electronic media coverage of FDA's public administrative 
proceedings. Under Sec. 10.205, representatives of the electronic media 
may be permitted, subject to certain limitations, to videotape, film, 
or otherwise record FDA's public administrative proceedings, including 
presentations by participants. The hearing will be transcribed as 
stipulated in Sec. 15.30(b). Orders for copies of the transcript can be 
placed at the meeting or through the Dockets Management Branch (address 
above).
    Any handicapped persons requiring special accommodations in order 
to attend the hearing should direct those needs to the contact person 
listed above.
     To the extent that the conditions for the hearing, as described in 
this notice, conflict with any provisions set out in part 15, this 
notice acts as a waiver of those provisions as specified in 
Sec. 15.30(h).
     To permit time for all interested persons to submit data, 
information, or views on this subject, the administrative record of the 
hearing will remain open following the hearing until June 20, 1994. 
Persons who wish to provide additional materials for consideration 
should file these materials with the Dockets Management Branch (address 
above) by June 20, 1994.

    Dated: March 1, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-5130 Filed 3-2-94; 2:55 pm]
BILLING CODE 4160-01-F