Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

This post was written by Paul Sheives.

FDA announced a two-day public hearing to be held on September 27 -28, 2010 to seek public input on a new framework for the development and distribution of patient medication information (PMI) to be provided to patients with prescription drug products. FDA is considering the use of a single, standardized document with consistent format and content. FDA seeks input on processes and procedures for standardizing PMI using a quality system approach for monitoring the development and distribution of PMI. Registration for the meeting closes September 13, 2010. FDA is accepting written comments on the issue until October 29, 2010. 

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This post was written by Paul Sheives and Areta Kupchyk.

FDA has issued a guidance document entitled “Label Comprehension Studies for Nonprescription Drug Products“ to provide recommendations to industry on conducting label comprehension studies for OTC drug products. The guidance discusses situations where FDA might require a label comprehension study, and provides guidance on the design and conduct of such studies, including the preparation of final reports and various statistical issues inherent to these studies.

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This post was written by Paul Sheives.

FDA seeks public comment on a study being conducted by the agency that is designed to test different ways of presenting information about prescription drugs to patients. Specifically, FDA seeks to determine, based on different prototype testing, whether consumers are able to comprehend serious warnings, directions for use, drug indications and uses, contraindications, and side effects in the prototype. The deadline for submission of comments is July 6, 2010.

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This post was written by Paul Sheives.

FDA will hold a public meeting entitled“Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors” on June 24-25, 2010 in Bethesda, Maryland. The meeting is intended to seek input from interested parties about the design of drug and therapeutic biologic container labels, carton labeling, and product packaging, and practices to develop proprietary names to reduce medication errors. Based on the information received at the meeting, and through the submission of written comments, FDA will develop a draft guidance for industry on this subject. Written comments are due by June 23, 2010.

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The FDA has released final guidance for industry entitled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The document describes how FDA reviews and evaluates patient-reported outcome (PRO) instruments (i.e., a questionnaire plus supporting information and documentation) used to measure treatment benefit in medical product clinical trials. It also provides recommendations on how sponsors can use study results measured by PRO instruments to support claims in approved medical product labeling.

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This post was written by Paul Sheives.

FDA recently released two guidance documents (one in draft form) concerning hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C), which provide information to manufacturers seeking licensure and potential sponsors for Investigational New Drugs Applications (INDs). FDA announced that it no longer intends to exercise enforcement discretion regarding IND and Biologics License Application (BLA) requirements for these products. The final guidance document is entitled “Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,” and the draft guidance is entitled “Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications.” Other recent FDA guidance documents include the following:

• Labeling for Human Prescription Drug and Biological Products--Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.
• Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.
• Guidance for Industry on Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects.

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