Labeling: BIO Submits Comments to FDA on Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products

Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products.” 

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.  

GENERAL COMMENTS

BIO appreciates additional FDA guidance on labeling issues for Sponsors which is consistent with many previous guidelines, as well as with recently approved labeling.  BIO recognizes the importance of the "Physician Labeling Rule" to provide a common format for FDA approved labeling that conveys the pertinent information for Health Care Professionals (HCP) to assess the relevance of a drug for their respective patients.  As such, the intent of the PATIENT COUNSELING INFORMATION section is not to inform prescribing behavior or to supplant HCP discretion in their medical practice decisions, as that decision has already been determined by the HCP, but rather to facilitate the HCP - Patient dialogue.

BIO has long advocated for a balanced approach to benefit-risk assessments throughout the lifecycle of a drug. According to the Draft Guidance, the PATIENT COUNSELING INFORMATION section should only focus on major risks of the drug and how a patient may mitigate or manage them.  We believe it is important to present information on safe and effective use of the drug in this section - as well as all sections - using a balanced benefit-risk approach.  Although it is important to convey to health care providers the major risks that should be communicated to the patient, it is equally important for them to convey the benefits of the product to the patient.  Communicating solely the risks of a product may have the unintended consequence of the patient not taking the medication, which can also result in negative health outcomes.  At a minimum BIO recommends that this section provide a reference to the benefits as described in the Indications and Usage section of the labeling.

Additionally, the information included in this section should be actionable by the patient, such as direction to contact the HCP if a symptom of an adverse event occurs, or the instructions for adherence if related to a safety or efficacy consideration.  Furthermore, this Draft Guidance recommends that information be presented using the active voice and provides several examples (e.g., “Advise the patient to...”).  BIO is concerned that such advising by Sponsors to physicians ventures into the practice of medicine.  We recommend that language such as “Read the FDA-approved patient labeling”, “Discontinue if...”,   or “Seek immediate attention if...” which should suffice for physicians to understand what to convey to patients.

We have also provided specific, detailed comments, in the following chart.

CONCLUSION

BIO appreciates this opportunity to comment on the “Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products.”  We would be pleased to provide further input or clarification of our comments, as needed.