2004D-0042 - Draft Guidances for Industry on Making Direct-to-Consumer Advertising More User Friendly; Availability
FDA Comment Number : EC3
Submitter : Ms. Tracy Klein Date & Time: 05/03/2004 05:05:28
Organization : American College of Nurse Practitioners
Health Professional
Category :
Issue Areas/Comments
The American College of Nurse Practitioners represents over 15,000 Nurse Practitioners in the United States. As part of its public policy agenda, access to health care for all includes access to information designed to help the consumer and health professional evaluate information on drugs, devices, and other health interventions for safety, efficacy, and applicability to individual health needs. As prescribers and primary care providers, we support provider neutral language in regulatory and consumer focused communications which includes the option to "ask your health care provider" if a medication is right for the consumer or patient.
The FDA industry guidelines draft (Docket 2004D-0042) includes three sections. The section "Brief Summary: Disclosing Risk Information in Consumer Direct Print Ads" offers several significant changes to simplify language and format of information to the consumer. Bullet points and use of a highlight window to increase the consumer's focus on risk information increases access to such language for consumers with limited literacy or comprehension skills. It would also be of potential use to patients with lower visual acuity if the most critical education points were in bold, clear, bulleted format. The ACNP would also like to acknowledge the provider neutral language referring to the patient's "health care provider" used throughout this guideline. Language used for the consumer should be at 8th grade reading level or less to reach as many consumers as possible. Multi-lingual (particularly Spanish) inserts should be considered. This is an acute need in specific regions, but also a broad need across the US.
The guideline ""Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms" uses the provider neutral term "health care practitioners" throughout the document. However, in line 101,the bullet point addresses advising the audience to "see your doctor" for possible diagnosis and treatment. Again, the ACNP urges the FDA to model use of the term "see your health care practitioner" for possible guidence and diagnosis. In both urban and rural areas across the United States, over 200,000 Nurse Practitioners, most with prescriptive authority, provide care to patients, often as their primary or sole provider. Inclusive language examples are found in line 173, referring consumers to a qualified "health care practitioner" for more information on specific diseases and their diagnosis.
In the final guideline "Consumer Directed Broadcast Advertising of Restricted Devices", paragraph B references placing information brochures in "a variety of publicly accessible sites (e.g., pharmacies, doctors' offices, grocery stores, public libraries)". We would suggest that the use of "doctors' offices" be broadened to "health care clinics and offices" to include a number of settings which may provide access to this information to the patient.