OMB Justification Memo

FDA DOCUMENTATION FOR THE GENERIC CLEARANCE
ON DATA TO SUPPORT DRUG PRODUCT COMMUNICATIONS
(0910-0695)
TITLE OF INFORMATION COLLECTION: Educating Groups Influencing Generic
Drug Use (interviews)
DESCRIPTION OF THIS SPECIFIC COLLECTION
1. Statement of Need:
The Food and Drug Administration (FDA), Center for Drug Evaluation and
Research (CDER), Office of Generic Drugs (OGD) is seeking OMB approval
under the generic clearance 0910-0695 to conduct key informant interviews (KII)
for the project “Educating Groups Influencing Generic Drug Use.”
Based on the supporting statement for generic clearance 0910-0695,1 the purpose
of information collection under this generic clearance is “to provide tools to
assess the need for communications on specific topics and to assist in the
development and modification of communication messages to promote public
health and compliance with regulations.” The specific collection described in this
memo aims to determine the informational needs of a variety of groups
influencing generic drug use in order to develop communications addressing gaps
in knowledge regarding generic drugs and promoting generic drug use. Exhibit 1
illustrates the full set of research phases for this project; please note that this
information collection request concerns only Phase 2.

Exhibit 1. Overview of Research Phases
Phase 1:
Systematic
review and
secondary
data
analyses to
determine
nature and
extent of
the
influence
key groups
have on
generic
drug use

Phase 3:
Development and
pilot testing
of
educational
material to
address
informational
needs
regarding
generic
drugs

Phase 2:
Key
informant
interviews
to
determine
informational
needs
regarding
generic
drugs

1
http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201509-0910-002

1

Phase 4:
Revision
of
educational
materials

Congress passed the Generic Drug User Fee Amendments (GDUFA, Title III of
the Food and Drug Administration Safety and Innovation Act (Public Law 112144)) in July 2012. Under GDUFA, FDA obtains industry and public input to
create regulatory science initiatives regarding research on generic drugs that
advance public health.2 Once marketed, certain generic drugs are often not
preferred over brand drugs3 even though generic drugs generally cost less than
brand drugs.4 Research to characterize the key influencers of generic drug use
(particularly for drug classes with low generic drug use), including their
knowledge base and perceptions toward generic drugs, is needed to effectively
design and deliver communications about generic drugs to the key groups
influencing consumer acceptance and use of generic drugs. To address this
regulatory science need regarding generic drugs, the FDA entered into a
cooperative agreement with investigators at Auburn University (Auburn) and
IMPAQ International (IMPAQ) (Grant Number 1U01FD005486-01).
In addition to prescribers, other groups such as pharmacists, patients and their
caregivers, formulary managers / pharmacy and therapeutics (P&T) committees,
federal and state policy makers, and larger purchasers of drugs (group purchasing
organizations, pharmacy chains, etc.) also influence the nature and extent of
generic drug use.5,6
Through a cooperative agreement with Auburn and IMPAQ, the informational
needs of these key groups regarding generic drugs will be explored by key
informant interviews.

2
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm370952.htm
3
Scher, S. (2013) The Branded Advantage. Ophthamol Mgmt. July: p18
http://www.ophthalmologymanagement.com/printarticle.aspx?articleID=108618
Alloway, RR, Isaacs R, Lake K, Hoyer P, First R, Helderman H, Bunnapradist S, Leichtman A, Bennett
MW, Tejani A, Takemoto SK. (2003) Report of the American Society of Transplantation Conference on
Immunosuppressive Drugs and the Use of Generic Immunosuppressants. A J Transpl 3: 1211.
Liow K, Barkley GL, Pollard JR, Harden CL, Bazil CW. (2007) Position statement on the coverage of
anticonvulsant drugs for the treatment of epilepsy. Neurology 68: 1249.
American Thyroid Association, The Endocrine Society, and American Association of Clinical
Endocrinologists. (2004) Joint Statement on the U.S. Food and Drug Administration’s Decision Regarding
Bioequivalence of Levothyroxine Sodium. Thyroid 14: 486.
4

IMS Institute for Healthcare Informatics. (2013) Avoidable Costs in U.S. Healthcare: The $200 Billion
Opportunity from Using Medicines More Responsibly.
http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Corporate/IMS Institute/RUOM2013/IHII_Responsible_Use_Medicines_2013.pdf
5
Tang Y, Gellad WF, Men A, Donohue JM. (2014) Impact of Medicare part D plan features on use of
generic drugs. Medical care. 52(6):541-548.
6
Berg MJ, Gross RA, Haskins LS, Zingaro WM, Tomaszewski KJ. (2008) Generic substitution in the
treatment of epilepsy: patient and physician perceptions. Epilepsy & behavior 13(4):693-699.

2

2. Intended use of Information:
Data collected from these key informant interviews will be used to inform the
development of educational materials to address the key groups’ knowledge gaps
regarding generic drugs (Phase 3).

3. Description of Respondents:
Key informants in each of the following 6 groups will be interviewed:
 Patients / caregivers
 Prescribers
 Pharmacists
 Formulary managers
 Policymakers (federal and state)
 Large purchasers of drugs (group purchasing organizations, pharmacy
chains, etc.)

4. Date(s) to be Conducted:


September 15, 2016 – March 14, 2017

5. How the Information is Being Collected:
Recruitment
A marketing research firm, Baltimore Research, will assist with recruitment and
scheduling. Baltimore Research will utilize private lists to recruit physicians,
pharmacists, patients, and/or caregivers. Participant screeners differ by group (see
Table 1 below and attachments). Participants will receive a reminder from
Baltimore Research of their scheduled interview two days prior to the scheduled
interview. The Auburn University/IMPAQ research team will develop a list of
formulary managers, policymakers, and large purchasers of drugs for recruitment.
Participants for these three groups will be identified in collaboration with the
FDA and GPhA and no formal screeners will be utilized in identifying members
for these three groups. More targeted, informal recruitment will be conducted
with these three groups in order to allow the research team to better identify
participants from various stages of generic drug utilization (e.g. large purchasers)
or across different levels of policy (e.g. state or federal levels of policymaking)
rather than general eligibility as with the patient, pharmacist and physician
groups.

3

Table 1. Eligibility for Respondent Groups
Group
Eligibility
Physicians
Prescribed a drug in a
community/institution setting in the past
month
Pharmacists
Practicing and dispensing/managing at a
pharmacy in any setting (chain,
independent, or hospital)
Patient/Caregiver
Is 19 years or older, and has taken a
generic drug/or serves as a proxy to a
patient who has taken a generic drug in
the past 6 months
Formulary Managers
Current member of a P&T committee at
the hospital or health plan level
Policymakers
Current federal or state government
employee with jurisdiction over generic
drug policy
Large Purchasers of Drugs
Bulk purchaser of drugs for large retail
chains (e.g., with more than 10
pharmacies) or group purchasing
organization

Key Informant Interviews
Skilled interviewers from Auburn and IMPAQ will conduct up to sixty (60) phone
interviews with no less than nine participants from the patient/caregiver,
physician and pharmacist groups and no less than four participants from the
formulary managers, policymakers and large drug purchasers of drugs groups.
Each sixty (60) minute interview will be based on a list of questions (interview
guides attached), with additional probing and discussion. Interviews will be audio
recorded and transcribed (see below).
Participation is voluntary. Before the interview begins, the facilitator will obtain
verbal consent from the participant to record the session. The informational letter
(attached) also mentions the audiotaping. The interviewer will review the
informational letter and request permission to audio record the interview prior to
the start of the interview.
Transcription of the audio recordings will be used to analyze participant
responses.

4

6. Confidentiality of Respondents:
Auburn, IMPAQ, Baltimore Research, and FDA will comply with safeguards for
ensuring participant information is kept private to the extent permitted by law.
The interviewees will be informed about how the recordings are used in the
analyses, and assured that the recorded data are kept strictly confidential.
Recordings will be saved on a secure webserver prior to being stored on a secure
server at the IMPAQ headquarters. Once recordings are downloaded to the
IMPAQ server, they will be deleted from the webserver. Audio recordings will be
transcribed, and transcriptions will be saved and stored in a de-identified format
on the IMPAQ server. Verbatim quotes included in the final report will not be
attributed to any individual.
Data from this study may be used in publications and/or presentations.
Participant names and other identifying information will be removed before the
data is used. Identifying information will not be used in publications unless
written consent from participants is obtained.

7. Amount and Justification for any Proposed Incentive:
The proposed compensation for each group may be found in Table 2. The
proposed compensation or “incentive” is not a reward or salary. Rather, it is a
stimulus to participate in the interview. Proposed incentive rates are in accordance
with standard practice and based on several factors including education and
training, level of expertise, access to participants, and willingness to participate.
More specifically, incentives for subspecialties of physicians and pharmacists are
based on these factors as well as the necessity to include representation from these
subspecialties for their unique role in generic drug utilization. It is well
documented in the research that money spent on the promotion of prescription
drugs varies significantly between primary care providers and specialists,
ultimately influencing their prescribing patterns7 and oncologists are likely to
prescribe very high cost drugs.8 Likewise, differences in setting may uniquely
influence retail-based pharmacists and hospital-based pharmacists.9 Therefore, to
ensure that we capture a complete picture of the beliefs, informational needs, etc.,
of generic drugs among primary care providers as well as specialists and high cost
drug prescribers such as oncologists and surgeons, it is imperative that the
research team be able to recruit participants from each of these subspecialties.

7
Kornfield, R., Donohue, J., Berndt, E., & Alexander, C. (2013). Promotion of Prescription Drugs to
Consumers and Providers, 2001–2010. PLOS One, 8(3), 1-7.
8
Experts in Chronic Myeloid Leukemia. (2013). The price of drugs for chronic myeloid leukemia (CML) is
a reflection of the unsustainable prices of cancer drugs: From the perspective of a large group of CML
experts. Blood, 121(22), 4439-4442.
9
Chiarello, E. (2012). How organizational context affects bioethical decision-making: Pharmacists'
management of gatekeeping processes in retail and hospital settings. Social Science and Medicine, 98, 319329.

5

Incentives are based on Baltimore Research’s experience. Offering an incentive
below these rates may result in increased costs exceeding the amount saved with a
lower incentive. Consequences of insufficient incentives include increased time
and cost of recruitment, increased “no-show” rates, and increased probability of
cancelled or postponed interviews.
Table 2. Respondent Compensation
Group
Physicians10
 Primary Care Providers
 Specialist
 Oncologists and
Surgeons
11
Pharmacists
 Retail
 Hospital
Patient/Caregiver
Formulary Managers
Policymakers
Large Purchasers of Drugs

Incentive Amount
$175
$250
$375

$150
$200
$50
$150
Not Applicable
$150

Incentives will be distributed upon completion of the interviews. For those
participants receiving $50 incentives (i.e., patients and caregivers), the incentive
will be distributed as two $25 gift cards. No taxes will be withheld. The name and
address of the recipient and date mailed will be the only information noted.
Participants receiving an incentive over $50 will be required to complete an
information form as well as a W-9 form. These will allow IMPAQ International
accountants to properly withhold taxes on the recipient’s behalf. Incentive
amounts calculated after tax withholdings will be distributed in checks. All
financial records will be kept confidential and stored on a secure server.
Information will not be shared with anyone outside of the IMPAQ financial staff.
Upon completion of this project, all confidential participant information not
pertinent to financial record keeping will be destroyed.
8. Questions of a Sensitive Nature:
There will be no questions of a sensitive nature asked of participants.

10
Incentives are based on physician specialty, level of expertise, years in school and average salaries. The
more schooling and training, the higher the incentive. Incentives are also based on willingness to
participate. For example, dermatologists are very difficult to recruit because their rate is high enough that it
is more beneficial to see patients than to participate in research.
11
The $150 incentive is for retail pharmacists. The incentive for hospital pharmacists is $200. These
incentives are based on the pharmacist, availability, specialty and willingness to participate. More
specifically, retail pharmacists are more prevalent than hospital-based pharmacists, making hospital
pharmacists more difficult to recruit.

6

9. Description of Statistical Methods:
This is a qualitative study using a convenience sample. As such, the analyses do
not entail the use of statistics.
Using NVivo 10 software, initial themes from the transcripts will be identified
and then discussed until all team members agree on major themes and a final code
book. Team members’ coded data will be compared for variations and
periodically discussed as needed until consensus is reached.
BURDEN HOUR COMPUTATION (Number of responses (X), estimated response or
participation time in minutes (/60) = annual burden hours): Approximately 60 hours in
total based on 1 hour interviews for a maximum of 60 participants across 6 groups. It
should be noted that the anticipated total number of interviews is only 54, but we have
included the maximum number of respondents and burden in order to allow the
researchers the possibility to conduct additional interviews to reach saturation.
Table 3. Estimated Reporting Burden
Type/Category of
No. of Respondents
Respondent

Participation
Time
(minutes)
60

Burden
(hours)
14

14 (at least 1 oncologist
or surgeon and 2
specialists)
14 (at least 2 hospitalbased pharmacists)
6

60

14

60

14

60

6

Policy makers
(federal and state)

6

60

6

Large purchasers of
drugs (group
purchasing
organizations,
pharmacy chains,
etc.)
Total

6

60

6

Patients / caregivers

Prescribers

Pharmacists
Formulary managers

14

60

REQUESTED APPROVAL DATE: July 1, 2016. Approval later than the beginning of
July 2016 would likely hinder recruitment for the proposed interview dates.

7

NAME OF PRA ANALYST & PROGRAM CONTACT:
Domini Bean
Paperwork Reduction Act Staff
[email protected]
301.796.5733
Lucie Yang, MD, PhD, MBA
Director (Acting), Division of Quality Management Systems
Office of Generic Drugs
301.796.5112
[email protected]
FDA CENTER: Center for Drug Research and Evaluation

8