[Federal Register: July 13, 2001 (Volume 66, Number 135)]
[Notices]
[Page 36794-36795]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jy01-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0314]
Guidance for Industry on Levothyroxine Sodium Products--
Enforcement of August 14, 2001, Compliance Date and Submission of New
Applications; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Levothyroxine Sodium
Products--Enforcement of August 14, 2001, Compliance Date and
Submission of New Applications.'' This guidance discusses how FDA plans
to exercise its enforcement discretion after August 14, 2001, with
regard to levothyroxine sodium products that are marketed without
approved applications. This guidance also answers certain frequently
asked questions concerning the submission of applications for
levothyroxine sodium products. It replaces the previously issued
guidance entitled ``Levothyroxine Sodium, Questions and Answers''
(February 2001).
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the guidance to the Dockets Management Branch (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: David T. Read, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Levothyroxine Sodium Products--Enforcement of August 14,
2001 Compliance Date and Submission of New Applications.'' This
guidance discusses how FDA plans to exercise its enforcement discretion
after August 14, 2001, with regard to levothyroxine sodium products
that are marketed without approved applications. This guidance also
answers certain frequently asked questions concerning the submission of
applications for levothyroxine sodium products and replaces the
previously issued guidance entitled ``Levothyroxine Sodium, Questions
and Answers'' (February 2001) (see 66 FR 13935, March 8, 2001).
In the Federal Register of August 14, 1997 (62 FR 43535), FDA
announced that orally administered levothyroxine sodium drug products
are new drugs. The notice stated that by August 14, 2000, manufacturers
who wish to continue to market these products must obtain approved
applications as required by section 505 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 355) and 21 CFR part 314. The notice
stated that after August 14, 2000, any orally administered drug product
containing levothyroxine sodium that is introduced or delivered for
introduction into interstate commerce without an approved application
will be subject to regulatory action, unless found by FDA to be not
subject to the new drug requirements of the act under a citizen
petition submitted for that product. FDA issued a second Federal
Register notice on April 26, 2000 (65 FR 24488), extending the deadline
for obtaining approved applications until August 14, 2001.
The agency permitted orally administered levothyroxine sodium
products to remain on the market during this period of time without
approved new drug applications to give manufacturers time to conduct
the required studies, prepare applications, and have them approved. FDA
stated in the 1997 Federal Register notice that levothyroxine sodium
products are used to treat hypothyroidism, and no alternative drug is
relied on by the medical community as an adequate substitute.
As of June 2001, two orally administered levothyroxine sodium
products have been approved by FDA. These approved products have been
evaluated by FDA and found to be safe and effective for their intended
uses. FDA has not evaluated the safety and effectiveness of unapproved
marketed products, but it has determined that no currently marketed
unapproved orally-administered levothyroxine sodium product is
generally recognized as safe and effective (see 62 FR 43535 at 43538,
August 14, 1997).
Notwithstanding the fact that there are now two approved
applications for orally administered levothyroxine sodium, FDA has
determined that it will take time for the millions of patients taking
unapproved products to switch to approved products, and for
manufacturers of approved products to scale up their production and to
introduce this increased production into the distribution chain. To
provide time for manufacturers of approved products to scale up their
production and for patients and health care providers to make a
reasonable transition from unapproved to approved products, FDA has
decided to continue to exercise its enforcement discretion by
establishing a gradual phase-out of unapproved products. The phase-out
plan and a number of frequently asked questions are addressed in this
guidance.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000).
The guidance is being implemented immediately without prior public
comment because there are public health reasons for the immediate
implementation of the guidance document. The guidance pertains to the
agency's exercise of enforcement discretion and it is being issued to
facilitate planning by patients, health care providers, manufacturers,
and distributors who need information about the agency's plans to
transition patients from unapproved to approved levothyroxine sodium
products after August 14, 2001. The guidance represents the agency's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Comments
Interested persons may, at any time, submit written or electronic
comments
[[Page 36795]]
on the guidance to the Dockets Management Branch (address above). Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. The guidance and
received comments are available for public examination in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either
http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/
dockets/default.htm.
Dated: July 9, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-17538 Filed 7-12-01; 8:45 am]
BILLING CODE 4160-01-S