Division of Dockets Management [HFA-305] Food and Drug Administration 5630 Fishers Lane Room 1061
Division of Dockets Management [HFA-305]
Food and Drug Administration
5630
Fishers Lane Room 1061
Rockville, MD
20993
RE: [Docket No. FDA-2010-N-0437]
–Development and Distribution of
Patient
Medication Information for Prescription
Drugs
To the Food and Drug
Administration
AVAC, a non-governmental
public health organization, thanks you for this
opportunity to submit comments to the proposed
new framework for development and distribution
of Patient Medication Information (PMI) for
Prescription Drugs. AVAC uses education, policy
analysis, advocacy, and community mobilization
to accelerate the ethical development and
eventual global delivery of AIDS vaccines and
other new HIV prevention options as part of a
comprehensive response to the
pandemic.
AVAC’s interest in PMI for
prescription drugs springs from our current
efforts to support biomedical and behavioral
research into HIV prevention using oral pre-
exposure prophylaxis (PrEP), microbicides
containing anti-retroviral agents and other
methods . Both PrEP and microbicides are being
tested for safety and effectiveness in clinical
trials in the US, Latin America, Africa and
Asia. If these interventions
prove safe and effective, then they may be
offered in the US on a prescription basis, and
will be accompanied by PMI. Both PrEP and
microbicides will most likely require a
comprehensive system to secure a patient’s
adherence, access to continued monitoring,
counseling and other behavioral support
recommendations to maximize effectiveness. PMI
inserts will likely be a critical tool in
supporting these systems and ultimately HIV
prevention. These comments are directed towards
these example HIV prevention related
considerations of the proposed
rule.
I. Comments.
PrEP and microbicides may potentially require PMI information for example which reinforces HIV behavioral prevention messages, as well as messages about adherence to PrEP or microbicide regimens, cautions against drug sharing and also patient monitoring. Great challenges are expected in use of these products in different populations if they are made available. Useful information may vary for different groups.
Although product sponsors may be capable of addressing the informational requirements of disclosure of safety data, they may not be able to craft fully adequate HIV prevention messages that could beneficially accompany these products. The accompanying messages on HIV risk are not those which product sponsors have experience in developing. Research has shown that even with OTC products, certain messages can be more effective than others in reducing HIV risk. 1 Effectiveness of these products, and protection of their users against HIV infection, will require carefully crafted PMI. These messages should be drafted by experts, in conjunction with public health agencies such as the CDC, or state and local HIV prevention offices and other capable stakeholders. For these reasons, FDA should err on the side of caution by continuing oversight over PMI for HIV prevention indications to maximize the potential protection of these and other non-HIV related health interventions.
B. Greater Public Outreach Will Improve PMI Development
FDA notes that “an evaluation of [Consumer Medication Information] in 2008 showed that while 94 percent of consumers receive CMI with new prescriptions, only 75 percent of CMI received met even minimum criteria for usefulness.”2 This sobering finding led the Risk Communication Advisory Committee (RCAC) to recommend that the FDA develop “a single standard document for communicating essential information about pharmaceuticals, which would replace the current set (PPI, CMI, and MG), through an appropriate consultative process.” 3
The FDA hearing held on September 27 and 28, 2010 was an important beginning to this “consultative process.” FDA has considered the views of industry, researchers and advocates but has not canvassed or performed easier venued outreach to patients for their opinions . To do so effectively, FDA should step out of the formal venue of Federal Register announcements and D.C. based workshops and conduct meaningful public and community outreach to determine the public’s views about PMIs. This outreach effort represents a public education opportunity that may serve the purposes of advancing patient safety, comprehension and beneficial use of drugs.
Finally, FDA has not offered its opinions or thoughts about potential consequences of its ideas on issues of preemption for failure to warn. Patient safety and protection may also be affected by these considerations. AVAC requests further public discussion of this topic.
Conclusions
We look forward to efforts to improve the quality of PMI delivered to individuals utilizing future HIV prevention products. Please contact Kevin Fisher, AVAC Policy Director, (212-367-1051; Kevin@avac.org) if you have any questions.
Sincerely yours,
Mitchell Warren
Executive Director
2 75 Fed. Reg. 52766 3 Minutes of the Risk Communication Advisory Committee (RCAC) February 26 and 27, 2009.
1 Bleakley A, Fishbein M, Holtgrave D, An Assessment of the Relationship between Condom Labels and HIV-Related Beliefs and Intentions, AIDS Behav 12:452–458 (2008)
2 75 Fed. Reg. 52766
3 Minutes of the Risk Communication Advisory Committee (RCAC) February 26 and 27, 2009.