On August 2, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule amending existing regulations (21 C.F.R. § 201.128 and 21 CFR § 801.4) that describe the types of evidence relevant to determine a drug or device’s intended use under the Food, Drug and Cosmetic Act (“FDCA”). See 86 Fed. Reg. 41,384–85. … Continue Reading
The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products. What is a biosimilar product? Biosimilar products are biological products that are highly similar to an FDA-approved biological product, known as a reference product. … Continue Reading
This post was written by Jillian W. Riley. On June 6, 2014, the US Food and Drug Administration (FDA) issued a draft guidance addressing the distribution of new risk information to health care providers (HCPs) and health care entities (HCEs). The draft guidance defines “new risk information” as “information that becomes available after a drug … Continue Reading
In a notice published in the Federal Register on May 7, 2014, the U.S. Food and Drug Administration (“FDA”) announced its intent to incentivize manufacturers to voluntarily update their prescription drug and biologics labels by using a government contractor. FDA’s announcement stems from a January 2006 final rule in which FDA established revised content and … Continue Reading
While attention has been focused on Medicare physician payment data released by CMS yesterday, upcoming Sunshine Act data will shine a new spotlight on financial relationships between physicians and pharmaceutical and medical device companies - with potential False Claims Act (FCA) implications.
Specifically, last week marked the deadline for pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit aggregate 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services (CMS) on certain financial relationships between themselves and physicians and teaching hospitals, as required by the Physician Payment Sunshine Act. In May, manufacturers and GPOs will be required to submit to CMS detailed 2013 payment data. With some exceptions, CMS will be making these data public by September 1, 2014. While the publicly-available data are intended to provide more transparency for patients, to allow them to have a better understanding of the financial relationships between physicians and pharmaceutical and medical device companies, patients will certainly not be the only group interested in this public information. It is likely that the Department of Health and Human Services Office of the Inspector General, Department of Justice, and relators' attorneys will utilize these data to initiate investigations and support complaints under the federal FCA.… Continue Reading
On April 29 and 30, 2013, the Food and Drug Administration (FDA) is hosting a public workshop on “Accessible Standardized Medical Device Labeling." The purpose of the event is to discuss the need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers … Continue Reading
The OIG has released two reports focusing on dietary supplements, one examining labeling claims and the other reviewing the FDA’s ability to identify and contact manufacturers in a public health emergency. In the first report, “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements,” the OIG analyzed structure/function claims for a sample of 127 dietary … Continue Reading
This post was written by Erin Janssen. The FDA has published a Small Entity Compliance Guide entitled “Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications.” This guidance is intended to help small businesses understand and comply with the requirements of the October 28, 2008 final rule on labeling … Continue Reading
This post was written by Erin Janssen and Areta Kupchyk. On October 12, 2011 the FDA announced the availability of guidance for the industry entitled “Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products–Content and Format.” This guidance is intended to assist applicants and reviewers in drafting the … Continue Reading
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, … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
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 … Continue Reading
