[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
