Notice: Guidance for Industry on Medication Guides--Adding a Toll-Free 
Number for Reporting Adverse Events; Availability

Federal Register: June 8, 2009 (Volume 74, Number 108)         
                  Page 27152-27153

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Medication Guides--
Adding a Toll-Free Number for Reporting Adverse Events.'' Beginning 
July 1, 2009, manufacturers of prescription drug products approved 
under the Federal Food, Drug, and Cosmetic Act (the act) that are 
required to have a Medication Guide must add a verbatim statement to 
their Medication Guides containing FDA's toll-free number for reporting 
side effects. These manufacturers are also required to report to FDA 
that they have complied with this requirement. This guidance explains 
what statement to add to Medication Guides, where to add it, and how to 
notify the agency that such a statement has been added.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. Submit written comments on the draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  Nancy Clark, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-5400, 
Nancy.Clark@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Medication Guides--Adding a Toll-Free Number for Reporting 
Adverse Events.'' On September 27, 2007, the President signed into law 
the Food and Drug Administration Amendments Act (FDAAA) (Public Law 
110-85). Among other things, FDAAA reauthorized the Best 
Pharmaceuticals for Children Act (BPCA) (Public Law 107-109). When 
enacted in 2001, the BPCA directed FDA to issue a final rule requiring 
the labeling of each human drug product for which an application is 
approved under section 505 of the act (21 U.S.C. 355) to include: (1) A 
toll-free number maintained by FDA for the purpose of receiving reports 
of adverse events regarding drugs and (2) a statement that the number 
is to be used for reporting purposes only, not to receive medical 
advice. The BPCA stated that the final rule must reach the broadest 
consumer audience and minimize the cost to the pharmacy profession. As 
required, FDA issued a proposed rule entitled ``Toll-Free Number for 
Reporting Adverse Events on Labeling for Human Drug Products'' (69 FR 
21778, April 22, 2004), which would require, among other things, that a 
side effects statement be included in FDA-approved Medication Guides 
for drug products approved under section 505 of the act.
    FDA received 22 comments on this proposed rule and was in the 
process of analyzing the comments and conducting research on consumer 
comprehension of the side effects statement when FDAAA was enacted. 
Section 502(f) of FDAAA stated that ``the proposed rule * * * entitled 
`Toll-Free Number for Reporting Adverse Events on Labeling for Human 
Drug Products' * * * shall take effect on January 1, 2008,'' unless FDA 
issues a final rule before that date. FDA did not issue a final rule by 
January 1, 2008, so

[[Page 27153]]

as mandated by FDAAA, the provisions of the proposed rule went into 
effect on that date.
    FDAAA mandated one change to the proposed rule. Section 502(f)(2) 
of FDAAA stated that the toll-free number proposed rule shall not apply 
to over-the-counter (OTC) drugs marketed with an application approved 
under section 505 of the act (application OTC drug products) if these 
application OTC drug products meet certain labeling requirements. 
Because the agency's rulemaking process was ongoing on January 1, 2008, 
an interim final rule was issued on January 3, 2008 (73 FR 402) that 
codified the provisions of the proposed rule as modified by FDAAA. The 
interim final rule stated that FDA anticipated that affected entities 
would need time to update labeling and systems to comply with the new 
requirements and that FDA intended to exercise its enforcement 
discretion and not take action to enforce the toll-free number 
requirements in the interim final rule until January 1, 2009. The 
interim final rule also stated that the agency planned to complete 
research begun on the proposed labeling statements and would issue a 
final rule taking into account the results of that research. In the 
Federal Register of October 28, 2008 (73 FR 63886), FDA issued a final 
rule with an effective date of November 28, 2008, and a compliance date 
of July 1, 2009. The agency is publishing this guidance to assist 
manufacturers in complying with the final rule.
    This level 1 guidance is being issued for immediate implementation 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). FDA has determined that prior public participation is not 
feasible or appropriate because the side effects statement is required 
by Congress and the compliance deadline for its inclusion in Medication 
Guides is July 1, 2009 (21 CFR 10.115(g)(2)). If comments are received 
on this level 1 guidance, FDA will review the comments and revise the 
guidance if appropriate. The guidance represents the agency's current 
thinking on adding a toll-free number to Medication Guides and 
reporting this to the agency. 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. The Paperwork Reduction Act of 1995

    The required side effects statement is not subject to the Office of 
Management and Budget (OMB) review under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501-3520) because it is ``originally supplied by the 
Federal Government to the recipient for the purpose of disclosure to 
the public'' and is not considered a collection of information under 
the PRA (5 CFR 1320.3(c)(2)). The guidance on notifying FDA in the 
drug's annual report that the side effects statement has been added to 
the drug's Medication Guide is covered by previously approved 
collections of information found in FDA regulations. The collections of 
information in 21 CFR 314.70(d) (changes to an approved application to 
be described in an annual report) and 314.81(b)(2)(iii)(c) (a summary 
of labeling changes that have been made since the last annual report) 
have been approved under OMB control number 0910-0001 for human drugs.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: June 1, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13273 Filed 6-5-09; 8:45 am]

BILLING CODE 4160-01-S