As the U.S. Food and Drug Administration (FDA) works to issue more guidance for industry on “patient-focused drug development” to satisfy its statutory obligations, companies should not view patient experience data solely as a tool for guiding drug development. Rather, collection of patient experience data provides an unexpected opportunity for research & development teams to collaborate with their commercial counterparts, thinking ahead about how patient experience data that are collected may be used in drug labeling, promotional launch materials, and beyond. Having patient experience data included in FDA-approved drug labeling gives companies an FDA-approved means for talking directly to healthcare professionals and patients about data points and outcomes meaningful to them. Moreover, it gives the drug manufacturer or marketer the ability to leverage the impact of promoting an approved drug product using the patient’s voice.

An example of how patient experience data have been commercially harnessed is FDA’s June 2017 approval of Rituxan Hycela (rituximab/hyaluronidase human), a subcutaneously administered product indicated for the treatment of several oncologic conditions. To gather patient experience data, the company conducted an open-label, crossover study, assigning patients to receive either intravenous Rituxan® (rituximab) or subcutaneous Rituxan Hycela, then crossed patients over to the alternative route of administration after four cycles and asked them to complete a questionnaire about their patient experience.

Specifically, a Patient Preference Questionnaire asked three questions: (1) which route of administration the patient preferred; (2) how strong the preference was; and (3) the two main reasons for that preference. Results from these data now appear in Rituxan Hycela’s FDA-approved labeling in a dedicated “Patient Experience” section that includes the company’s patient preference findings, namely that 77% of patients studied preferred the subcutaneous dose, as well as the reasons patients provided for preferring the subcutaneous or intravenous administration. Additionally, the company has leveraged these data commercially, promoting on its product website that “Nearly 8 in 10 Patients Preferred” Rituxan Hycela to Rituxan administration.

FDA’s Recommendations

FDA provides numerous recommendations to industry in its recent draft guidance regarding patient experience data collection, including:

  • Identify your target patient population and ensure selection will include a diverse set of patients rather than patients from a single site.
  • Select your desired sampling methods, which can include social media collection mechanisms, with a focus on ensuring data integrity.
  • Discuss data collection and patient experience study design plans early with FDA to ensure FDA buy-in.

Having a dedicated “Patient Experience” section in FDA-approved product labeling commercially can provide sales and marketing teams important information to communicate in promotional materials, especially for new products in crowded treatment spaces or disease areas not well-understood by professionals. As a result, in the development stage, patient-focused drug development creates an opportunity for early internal collaboration between R&D and marketing teams that should not be overlooked.

  • Julie Tibbets

    Julie Tibbets is a FDA Partner in the Technology & Life Sciences Group at Goodwin. Julie advises manufacturers and marketers on product promotion, disease awareness activities, and corporate communications. Since 2016, Julie has been listed in the Best Lawyers in America for FDA law.


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