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pdfU.S. Food and Drug Administration
Study of Disclosures to Health Care Providers Regarding Data
That Do Not Support Unapproved Use of an Approved Prescription Drug
OMB Control Number 0910-0900
No Material or Non-Substantive Change to a Currently Approved Collection (83-C)
This information collection supports section 1701(a)(4) of the Public Health Service Act (42
U.S.C. 300u(a)(4)), which authorizes the Food and Drug Administration (FDA) to conduct
research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research
relating to drugs and other FDA-regulated products in carrying out the provisions of the FD&C
Act.
FDA’s Office of Prescription Drug Promotion’s (OPDP) mission is to protect the public health
by helping to ensure that prescription drug promotion is truthful, balanced, and accurately
communicated. OPDP’s research program provides scientific evidence to help ensure that its
policies related to prescription drug promotion will have the greatest benefit to public health. We
have consistently conducted research to evaluate the aspects of prescription drug promotion that
are most central to our mission. This study in this information collection pertains to the two
topic areas: (1) advertising features and (2) target populations. Our purpose for the information
collection is to examine how physicians process information about unapproved new uses of
approved prescription drugs when made aware of other unsupportive information and how they
evaluate the effectiveness of various disclosure approaches for this information. This study has
provided and continues to provide FDA with empirical information of the effects that these
variables have on physician perceptions and has informed and continues to inform FDA’s
regulatory approach to materials of this type.
Proposed Changes
Based on the second round of cognitive testing, we propose changes to the questionnaire to
improve clarity, which will not change the amount of time required to complete it.
1. Additions. We propose to add one question to assess prior experience prescribing for the
target condition.
PRESCRIBING DRUGS
Have you ever prescribed [DRUG] for [DISEASE]?
Yes
No
2. Deletions. Based on the second round of cognitive testing, which suggested there was little
variability in responses, we have deleted Q2e and Q2f. The second round of cognitive testing
also revealed that participants did not distinguish between the terms contradict and
inconclusive. This is consistent with the first round of cognitive testing. Although we
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originally intended to test these as separate terms in the pretest, we have determined that
based on these two cognitive testing rounds, we will combine the wording into one question.
Accordingly, we have deleted separate questions Q21 and Q22. The new wording reads:
“Thinking of the studies you have seen in the past, how often have you seen study
findings that contradict or are inconclusive about an off-label use of a drug?”
3. Updates to wording: We have made the following updates to improve the clarity of the
questions and reduce the possibility of confusion.
Updates to Q2 instructions: Based on the second round of cognitive testing, the instructions
have been changed to read:
“Please indicate whether any of the following were mentioned in the materials you
reviewed.”
Updated prescribing frequency categories: We have updated the categories describing
frequency of prescribing drugs in Q15 to reflect the prescribing patterns described by
participants in the cognitive interviews.
How often do you prescribe a drug for an off-label use?
1 or more times a day
1-6 times a week
1-3 times a month
1-11 times a year
Less than once a year
I have never prescribed a drug for off-label use
Revised list: We revised the list of choices to add National Comprehensive Cancer Network
Guidelines, deleted the option choice online communities of physicians, and deleted one
open-ended answer option, Professional guidelines (please specify), in Q18/19 and Q25.
How often do you use the following sources to learn about off-label uses for a drug?
a. Colleagues
b. Medical journals
c. Google or other online search
engines
d. Medical reference websites such
as UpToDate or Epocrates
ASK ONLY TO ONCOLOGISTS
e. National Comprehensive Cancer
Network Guidelines
f. Professional medical association
conferences and communications
g. FDA
Never
Rarely
Sometimes
Often
Very
Often
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h. Pharmaceutical companies
i. Online communities of physicians
j. Key opinion leaders or thought
leaders in the field
k. Other, please specify
Added descriptor to list: We added “study duration” to the existing list in Q23b because
several cognitive interview participants mentioned it as important during the interviews.
How important is it to you to know about the following aspects of a study about an
off-label use of a drug?
a. Study population
b. Study design, e.g.,
randomized controlled
study, observational
study, study duration
c. Sample size
d. Findings related to
safety of the off-label
use
e. Findings related to side
effects of the off-label
use
f.
Study sponsor
g. Number of studies that
contradict or are
inconclusive about an
off-label use of a drug
Not at all
important
A little
important
Somewhat
important
Very
important
Extremely
important
Updated debriefing: We have updated the wording of the debriefing statement.
Debrief
Thank you for taking part in this survey. While the information presented is accurate, the
information provided about {DRUG} and its off-label use for {CONDITION} is a
combination of several different studies.
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4. Format: We have updated the format of Q2 so that all items are shown together instead of
one at a time in separate question parts. This is expected to save the participants’ time and
effort.
Please indicate whether any of the following were mentioned in the materials you
reviewed.
Yes
No
I’m not sure
a. A brief report on a study that supports use of
[DRUG] for [DISEASE]
b. A discussion of the limitations of a study that
c. A description of an experimental study design
d. Outcomes for a placebo group
e. The use of [DRUG] for [DISEASE] has been
approved by the FDA
SHOW FOR ALL CONDITIONS:
SHOW FOR ALL CONDITIONS:
supports use of [DRUG] for [DISEASE]
SHOW FOR ALL CONDITIONS:
SHOW FOR ALL CONDITIONS:
SHOW FOR CONDITONS 1-4 ONLY:
f.
SHOW FOR CONDITIONS 1-3 ONLY:
The materials summarize a study whose result
does not support the use of [DRUG] for
[DISEASE]
SHOW FOR CONDITIONS 2-3 ONLY:
g. The materials gave a citation for a study whose
result does not support use of [DRUG] for
[DISEASE]
SHOW FOR ALL CONDITIONS:
h. Information about whether the described use of
[DRUG] was off-label
5. Changes to informed consent language: Westat’s Institutional Review Board requested a
minor change in wording to one part of the Informed Consent.
Rights as a Participant
This study is voluntary. You do not have to answer any questions that you do not want to and
can withdraw from the study at any time. The Institutional Review Board at Westat has
reviewed this research study. If you have questions about your rights and welfare as a research
participant, please call the Westat Human Subjects Protections office at 1-888-920-7631. Please
leave a message with your first name, the name of the research study that you are calling about
(FDA Communication about Data), and a phone number beginning with the area code and
someone will return your call as soon as possible.
Dated: February 3, 2022
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| File Type | application/pdf |
| Author | Betts, Kevin |
| File Modified | 2022-04-15 |
| File Created | 2022-04-15 |