Labeling

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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.

This final rule, which takes effect as of September 1, 2021, withdraws and replaces a final rule that FDA promulgated on January 9, 2017, but which never became effective due to an outcry concerning a problematic knowledge provision that was contrary to the statutory scheme of the FDCA and to physicians’ autonomy to use FDA-approved products in an off-label manner.

Prior to the 2021 final rule, FDA issued a proposed rule on September 23, 2020 that eliminated the 2017 rule’s knowledge provision and was much more aligned with FDCA intent and current FDA policy and practice.  FDA maintains, and we agree, that August 2021 final rule remains largely unchanged from the 2020 proposed language.

The following is a review of some important changes that FDA regulated entities should take note of as they develop and market FDA regulated products:Continue Reading FDA clarifies evidence and knowledge requirements in intended use final rule

The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products.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. Notwithstanding minor differences in clinically inactive components, there can be no clinically meaningful differences between the biological product and the reference product in terms of the safety and efficacy.  In 2010, the Biologics Price Competition and Innovation Act (“BPCIA”) was enacted as part of the Affordable Care Act in order to provide an abbreviated licensure pathway for a biosimilar that partly relies on the data originally submitted to the FDA by the reference product sponsor for approval.
Continue Reading FDA Issues Draft Guidance on Labeling For Biosimilar Products

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 On June 6, 2014, the US Food and Drug Administration (FDA) issued a draft guidance addressing the distribution of new risk information to health care providers (HCPs) and health care entities (HCEs).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 is marketed that rebuts or mitigates information about a risk already identified in the approved labeling or otherwise refines risk information in the approved labeling in a way that does not indicate great seriousness of the risk.” The draft guidance is not intended to address risk information that is newly identified, but that which was not available at the time FDA approved the labeling. Acknowledging the evolving nature of a drug’s safety profile, the draft guidance is aimed at helping sponsors better communicate “new risk information” in order to allow HCPs and HCEs make the best decision for each patient.
Continue Reading FDA Issues Draft Guidance on Communicating New Risk Information about an Approved Drug Product – Comment Opportunity

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…

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 Will Physician Payment Sunshine Act Data Usher in a New Era of False Claims Act Litigation?

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…

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…

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…

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…

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…

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…

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…

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…