
[Federal Register: November 26, 2008 (Volume 73, Number 229)]
[Notices]               
[Page 72055-72058]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no08-82]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0162]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Prescription Drug 
Product Labeling: Medication Guide Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the

[[Page 72056]]

Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by 
December 26, 2008.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0393. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance:

Prescription Drug Product Labeling: Medication Guide Requirements (OMB 
Control Number 0910-0393--Extension)

    FDA regulations require the distribution of patient labeling, 
called Medication Guides, for certain prescription human drug and 
biological products used primarily on an outpatient basis that pose a 
serious and significant public health concern requiring distribution of 
FDA-approved patient medication information. These Medication Guides 
inform patients about the most important information they should know 
about these products in order to use them safely and effectively. 
Included is information such as the drug's approved uses, 
contraindications, adverse drug reactions, and cautions for specific 
populations, with a focus on why the particular product requires a 
Medication Guide. These regulations are intended to improve the public 
health by providing information necessary for patients to use certain 
medication safely and effectively.
    The regulations contain the following reporting requirements that 
are subject to the PRA. The estimates for the burden hours imposed by 
the following regulations are listed in the table 1 of this document:
     21 CFR 208.20--Applicants must submit draft Medication 
Guides for FDA approval according to the prescribed content and format.
     21 CFR 208.24(e)--Each authorized dispenser of a 
prescription drug product for which a Medication Guide is required, 
when dispensing the product to a patient or to a patient's agent, must 
provide a Medication Guide directly to each patient unless an exemption 
applies under Sec.  208.26 (21 CFR 208.26).
     21 CFR 208.26(a)--Requests may be submitted for exemption 
or deferral from particular Medication Guide content or format 
requirements.
     21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)--Application 
holders must submit changes to Medication Guides to FDA for prior 
approval as supplements to their applications.
    In the Federal Register of March 18, 2008 (73 FR 14471), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. We received the following comments:
    (Comment 1) The comments said that FDA's estimate of the hourly 
burden for pharmacists to comply with the Medication Guide requirements 
is inaccurate, and that pharmacists spend significantly more time 
determining whether a Medication Guide is required, tracking 
appropriate Medication Guides from manufacturers or distributors, 
explaining to the patient what the Medication Guide is, in addition to 
patient counseling. The comments noted that FDA's estimate that a 
pharmacist spends 0.0014 hours (5 seconds) to distribute each 
Medication Guide remains unchanged since the December 1, 1998, final 
rule entitled ``Prescription Drug Product Labeling; Medication Guide 
Requirements,'' even though the Medication Guide program has continued 
to expand (63 FR 66378). The comments said that FDA's estimates are 
inadequate and fail to consider the operational realities pharmacists 
now face in complying with the program. The comments said that pharmacy 
personnel spend tens of thousands of hours obtaining and distributing 
Medication Guides for each new prescription and all refills for 
Medication Guide medications.
    Response: FDA agrees with the comments. However, the comments did 
not suggest an alternative burden estimate for Medication Guide 
distribution by pharmacists. We are increasing the burden estimate for 
Sec.  208.24(e) to 3 minutes for each Medication Guide distributed by 
pharmacists. If the commenters believe that this estimate is 
insufficient, we request comments on why an alternative estimate would 
be more accurate. We are also increasing to 25 the number of Medication 
Guides that FDA receives per year under Sec.  208.20.
    (Comment 2) The comments also said that there are distributor costs 
to comply with the Medication Guide requirements, and table 1 in the 
March 18, 2008, Federal Register notice omitted Sec.  208.24(c), which 
provides that ``Each distributor or packer that receives Medication 
Guides * * * shall provide those Medication Guides * * * to each 
authorized dispenser to whom it ships a container of drug product.'' 
The comments said that the burden to distributors and packers to 
distribute Medication Guides--the process of tracking, sorting, 
matching, and shipping multiple versions of Medication Guides for 
multiple products--should be included in the analysis.
    Response: FDA agrees with the comments and is willing to include a 
burden estimate for Sec.  208.24(c). We are requesting comments on 
specific estimates for this requirement.
    (Comment 3) The remaining issues raised by the comments in response 
to the March 18, 2008, Federal Register notice are generally the same 
as the issues raised during FDA's public hearing on the use of 
Medication Guides to distribute drug risk information to patients 
(announced in the Federal Register of April 9, 2007 (72 FR 17559)) and 
the same as the comments submitted to that docket. (One commenter also 
referenced comments previously submitted to FDA in the ``June 2006 
White Paper on Patient Safety Implications on Implementation of the 
Current FDA-Mandated Medication Guide Program''). On July 2, 2007, FDA 
posted a ``Summary of Public Hearing on FDA's Use of Medication Guides 
to Distribute Drug Risk Information to Patients'' at http://
www.fda.gov/cder/meeting/SummaryPublicHearingMedicationGuides.htm. The 
issues raised in conjunction with the public hearing, as well as the 
comments summarized below, are still under consideration at FDA, and we 
have not yet decided what actions we will take in response to 
suggestions to modify the Medication Guide program.
    The following is a summary of the comments received on the March 
18, 2008, notice; these comments do not pertain to the specific burden 
estimates, but were taken into consideration by FDA.
    (Comment 4) The comments said that despite stating in the 
Medication Guide final rule that FDA will use Medication Guides 
sparingly, the agency continues to add new Medication Guides for drugs 
in a manner inconsistent with its

[[Page 72057]]

original intent. The comments said that FDA intended Medication Guides 
to be used only when a drug posed very serious or significant side 
effects, and that it anticipated the program to be limited to a small 
number of products, and not more than 5 to 10 products per year. The 
comments said that by 2004, about 20 products required Medication 
Guides, and that starting in 2005, FDA began requiring Medication 
Guides for entire medication classes, which have grown to include 
antidepressants, nonsteroidal anti-inflammatory drugs, and attention 
deficit hyperactivity disorder and sleep disorder drugs. The comments 
said that today almost 300 million prescriptions per year for over 
10,000 separate drug products are subject to the Medication Guide 
requirement, and pharmacists are dispensing Medication Guides for 
substantially more drugs than originally estimated. The comments said 
that this has created significant burdens for pharmacists.
    (Comment 5) The comments said that there is no evidence that a 
Medication Guide is a good vehicle for risk communication, and FDA has 
not provided evidence that the program is valuable to patients or 
improves the safe and effective use of prescription drugs. The comments 
said that given the amount of information patients are likely to 
receive with their prescriptions, they face a tremendous challenge in 
actually reading each piece of information. As a result, the comments 
said, many patients are likely to not read any material provided to 
them. Those patients that desire to gain additional information about 
their therapy but are unable to read each document are placed in a 
position of having to decide which document distributed to them is more 
important than the other. The comments said that FDA should first 
evaluate whether patients actually read the Medication Guides 
distributed to them, and then assess whether the information contained 
in a Medication Guide is easily understood by patients. The comments 
said that many patients are likely to find the information difficult to 
understand or confusing, and that many patients, especially older and 
disabled patients, have cognitive impairments that may pose tremendous 
challenges in understanding information contained in a Medication 
Guide. The comments also asked whether the information contained in the 
Medication Guide is already available to patients. For example, the 
comments said that pharmacists provide counseling on the safe and 
effective use of medication to their patients at the time of 
dispensing, and are able to translate highly complex information about 
a drug's characteristics, use parameters, side-effects and abuse 
potential. The comments said this counseling by pharmacists, coupled 
with other information already distributed to patients, such as 
consumer medication information and the patient package insert or the 
patient information sheet, raises questions about the need for the 
Medication Guide program. The comments also said that FDA has not made 
sufficient data available to the public to support the position that 
the Medication Guide program is important to communicate risk, and FDA 
should release all data from its surveys and studies for review and 
comment by health care provider groups. The comments said that this 
data will help generate a more accurate estimate of the burden imposed 
on the public as a result of the Medication Guide program.
    (Comment 6) The comments said that pharmacists face difficulties in 
obtaining Medication Guides. The comments said that some Medication 
Guides are included with the product itself in the package insert, some 
are provided in tear-off sheets, and some are available electronically. 
The comments said that the lack of a standardized delivery model 
complicates efforts to operationally streamline dispenser and 
distribution systems for duplicating and providing Medication Guides. 
In addition, pharmacists at times need to call a toll-free number to 
order hard copies of the Medication Guides for distribution. The 
comments said that FDA should establish standards for manufacturer 
distribution of medication guides and establish a single toll-free 
number or Internet site for pharmacies to use to obtain Medication 
Guides.
    (Comment 7) The comments said that FDA should waive certain 
Medication Guide formatting requirements to permit pharmacies to print 
Medication Guides through existing pharmacy computer systems. The 
comments said that permitting pharmacies to print Medication Guides 
would enhance their distribution and will free pharmacists' time to use 
for patient counseling and care. The comments also said FDA should 
permit pharmacies to e-mail Medication Guides to their patients.
    (Comment 8) The comments said that a single, uniform Medication 
Guide should be used for all brand and generic versions of the same 
drug, or for drugs within the same therapeutic class, with similar risk 
warnings, and that each brand and generic manufacturer of the same drug 
or the same class of drug should not have to produce its own Medication 
Guide. The comments said that for medications that have unique and rare 
side effects that are not shared with the other drugs in the same 
class, FDA should consider having a class Medication Guide that 
specifically lists per paragraph each drug in the class while 
highlighting risk information that is unique to certain medications 
within that class.
    (Comment 9) The comments said that Medication Guides should only be 
required the first time a prescription is filled, and thereafter only 
when requested by a patient for that prescription's refill.
    (Comment 10) The comments said to eliminate duplication and enhance 
the usefulness of patient information, a single, manufacturer-produced, 
patient-oriented FDA-approved Medication Information Document should be 
developed for each drug that currently requires a Medication Guide. 
This single document could combine consumer medication information and 
Medication Guide information. The comments said they are willing to 
work with FDA and other interested stakeholders in designing and 
implementing such a program. Alternatively, the comments said that FDA 
should standardize the information that must be included in the 
Medication Guide and require a consistent format, look, and feel to 
Medication Guide information.
    (Comment 11) The comments said that physicians and other providers 
should give the Medication Guide directly to the patient at the time 
the prescription is written. The comments said the physician is in the 
best position to discuss not only the possible risks associated with 
the medication but to also discuss alternative therapies if necessary. 
The comments also said that FDA should consider ways that prescribers 
could be better informed about medications that require Medication 
Guides.
    (Comment 12) The comments said that the Medication Guide 
requirements were imposed on distribution and dispensing entities that 
were neither prepared nor operationally structured (for example, lack 
of space, staff, and equipment) to prepare and provide for their 
dissemination.
    Based on the comments in ``Comment (1)'' of this document, FDA has 
revised the estimated annual reporting burden as follows:

[[Page 72058]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
208.20                            25                  1                 25                320              8,000
----------------------------------------------------------------------------------------------------------------
208.24(e)                     59,000              5,000        295,000,000               0.05         14,750,000
----------------------------------------------------------------------------------------------------------------
208.26(a)                          1                  1                  1                  4                  4
----------------------------------------------------------------------------------------------------------------
314.70 (b)(3)(ii)                  5                  1                  5                 72                360
 and 601.12(f)
----------------------------------------------------------------------------------------------------------------
Total                                                                                                 14,758,364
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: November 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28064 Filed 11-25-08; 8:45 am]

BILLING CODE 4160-01-S
