Last month, the U.S. Department of Justice (“DOJ”) quietly updated its March 2023 guidance on the evaluation of corporate compliance programs.[i] Of course, DOJ did not conduct a major rewrite, but interestingly, the updated guidance emphasizes the impact, and evaluation, of emerging technologies on compliance as well as the importance of data when assessing compliance programs.
Continue Reading DOJ Updates Guidance on Evaluation of Corporate Compliance Programs

On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television advertisement (TV ad) for UBRELVY® (ubrogepant) tablets, for oral use (Ubrelvy).[1] Ubrelvy is indicated for the acute treatment of migraine with or without aura in adults.[2] FDA concluded that the TV ad – which featured tennis star Serena Williams – misleadingly suggested that Ubrelvy provides greater benefits than has been demonstrated and was therefore misbranded under FDA regulations.
Continue Reading Ubrelvy Untitled Letter – A Double Fault for AbbVie? Or Makeup Misread for FDA?

On August 1, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Mirati Therapeutics Inc., a Bristol Myers Squibb Co. (Mirati), relating to promotional communications made on its Healthcare Provider Branded Website for its accelerated approval drug, KRAZATI™ (adagrasib) tablets, for oral use (Krazati).[1] Krazati is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy.
Continue Reading Krazati Untitled Letter: A Cautionary Tale for CFL Promotion of Accelerated Approval Drugs

On July 17, 2024—but just recently posted to the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) website—FDA issued its second untitled letter (letter) of the year to Kaleo, Inc. (Kaleo) over social media promotion of AUVI-Q® (epinephrine injection, USP). The social content was posted on the personal Instagram account of Brittany Mahomes—yes, that Mahomes. While the letter is splashy by virtue of its target and the message presented, the content, rationale, and findings by FDA are not surprising—linking to important safety information (ISI) alone is not enough, especially when the product is intended…
Continue Reading FDA’s Second Untitled Letter of the Year – An Apparently Tough Choice Between Raising Awareness and Public Safety for Anaphylaxis Drugs

On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and examples for firms who choose to address misinformation about or related to their approved or cleared drug or device.[1] This guidance revises and replaces FDA’s 2014 draft guidance titled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.” Social media users from 2014 will appreciate how different the world looks today and why—even though it took FDA ten years—this revision is a welcomed shift making it…
Continue Reading FDA Revisits and Updates Guidance on Addressing Misinformation – Ten Years Later

In this second installment of our nine-part deep-dive into the U.S. Food & Drug Administration (“FDA” or “the Agency”) final rule on Laboratory Developed Tests (“LDTs”) – which established a staged plan that will phase out the Agency’s previous policy of enforcement discretion for LDTs – we are taking a closer look at the response to the rule, not only from laboratories and other industry stakeholders but also from members of the legislature. The long and short of it is – people are not happy!
Continue Reading LDT Final Rule Series: Part 2 – Response to the Rule

On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations following a back-and-forth between FDA and Akan. The Form FDA-483 highlights a number of observations about 585 vials of an Akan product, but the warning letter spends considerable time beforehand covering reasons why Akan’s product does not meet the requirements of 21 C.F.R. § 1271.10(a), which qualify certain human cells, tissues, or cellular or tissue-based products (HCT/Ps) for exemptions from key FDCA requirements, including premarket review.
Continue Reading FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company

Recently, the Department of Health and Human Services Office of Inspector General (“OIG”) released Advisory Opinion (“Opinion”) 24-02 regarding patient assistance funds provided by a non-profit charitable organization (“Requestor”). This opinion marks the latest in a string of advisory opinions which have approved similar patient assistance programs (“PAPs”). As highlighted in previous advisory opinions, OIG reiterates the importance of the charity’s independence from pharmaceutical manufacturer influence.
Continue Reading OIG Issues Favorable Advisory Opinion Regarding Patient Assistance Funds

Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will phase out the Agency’s previous policy of enforcement discretion for Laboratory-Developed Tests (“LDTs”). The final rule was issued at an astonishing speed compared to FDA’s usual rulemaking timeline,[1] coming not even six months after FDA issued the proposed rule.
Continue Reading LDT Final Rule Series: Part 1 – Rule Overview

On April 2, the FDA issued a warning letter to Agena Bioscience Inc., alleging its product, intended for research use only (RUO), was promoted for clinical purposes and thus violated the Food, Drug, and Cosmetic Act.
Continue Reading FDA Warning Letter Regulates “Research Only” Labels

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors, investigators, and Institutional Review Boards.[i] The guidance provides suggestions on which topics of information should be included in the key information section of an informed consent as well as how information can be presented and formatted in an informed consent to aid prospective subjects’ understanding of a clinical trial.
Continue Reading Time to Refresh? FDA Issues Draft Guidance on Key Information and Informed Consent

On February 16, the U. S. District Court for the District of Oregon struck down the state’s drug price transparency law—The Prescription Drug Price Transparency Act (the “Act”)[1]—ruling that the Act’s annual price increase reporting requirement is unconstitutional and, therefore, unenforceable.[2] Following the District Court’s decision, the Oregon Department of Consumer and Business Services (“DCBS” or the “Department”) issued a bulletin indefinitely suspending the annual price increase reporting requirement.[3] However, the Department confirmed its intent to appeal the District Court’s decision,[4] leaving the future of the reporting requirement relatively uncertain.
Continue Reading Oregon Prescription Drug Price Transparency Act in Limbo

On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis Pharmaceuticals Corporation (Novartis) regarding a promotional, direct-to-consumer broadcast advertisement (TV Ad) for KISQALI® (ribociclib) tablets, for oral use, indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:…
Continue Reading FDA’s Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI®