Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors, investigators, and Institutional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 FDA Issues Draft Guidance on Key Information and Informed Consent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®

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the “Requestor”) and its proposed payment of cost-sharing subsidies. Maintaining its position from similar opinions issued in recent years, OIG said that it would not impose sanctions under the Federal Anti-Kickback Statute (the “AKS”) or the Beneficiary Inducements Civil Monetary Penalty (the “CMP”) against the Requestor for paying cost-sharing subsidies to clinical trial participants to cover the participants’ share of costs for reimbursable, study-related items and services that the participants would otherwise be required to pay out of pocket.[1] This Opinion illustrates that OIG appears to remain willing to permit arrangements that do not fall squarely within an AKS safe harbor in order to incentivize participation, especially diverse participation, in clinical trials for medical devices.Continue Reading OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although there was no single moment like the passage of the Affordable Care Act in 2010, there are numerous distinct events that will loom large in 2024 and beyond.Continue Reading 2024 Top-of-Mind Issues for Life Sciences Companies

In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and radio format (CCN Final Rule Guidance). The CCN Final Rule Guidance was released to advise small entities seeking to understand and comply with the standards established in the final rule, “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format” (CCN Final Rule).Continue Reading FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may exercise “march-in” rights and take a pharmaceutical company’s drug patents developed with federal funds and share them with other companies. See Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, available here.Continue Reading The March on Pharmaceutical Patents?

On October 23, 2023, the Food and Drug Administration (“FDA”) published a new draft guidance, titled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products, Questions and Answers (the “2023 Draft Guidance”). The 2023 Draft Guidance is a revision to, and builds upon, FDA’s 2014 draft guidance on the same issue, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices, which itself was a revision to FDA’s 2009 guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. Drug and device manufacturers (“firms”) will note that in the 2023 Draft Guidance, FDA introduces multiple new concepts. Addition of terms such as “SIUU Communications” and “Firm-Generated Presentations” appear to broaden the possibilities for firms’ communications with healthcare providers (“HCPs”) while inclusion of concepts such as “scientifically sound” and “clinically relevant” can be read as imposing certain limitations on what can be included in SIUU Communications. FDA’s inclusion of these new concepts provides both guidance and guardrails for firms to ensure SIUU Communications with HCPs stay in line with FDA regulatory requirements. With the 2023 Draft Guidance, FDA continues to be thoughtful and intentional with its views on communications between firms and HCPs, and demonstrates to industry that the agency will continue to evolve its thinking with the advent of new technologies, advancements in science, medicine, and the delivery of care, and in light of the ever-changing modes and methods of communication.Continue Reading From Good Reprint Practices to SIUU Communications: What Firms Need to Know

In late April this year, the Office of Inspector General, Department of Health and Human Services (OIG) announced that it would make changes to its existing body of healthcare compliance program guidance (CPGs) as part of its current Modernization Initiative.[1] These CPGs were directed at various segments of the health care industry and provided specific guidance on risks posed by industry practices. To kick off the initiative, OIG indicated that it would first issue a new general compliance program guidance (GCPG) by year end applicable to individuals and entities in all segments of the health care industry that would address overarching compliance elements regarding federal fraud and abuse laws, compliance program basics, compliance program effectiveness and general process and procedures. Thereafter, OIG said it planned to update existing industry-specific compliance program guidance (ICPG), which would include tailoring each to address fraud and abuse risk areas specific to a particular industry and describing the compliance measures that industry could take to reduce these risks[2].Continue Reading OIG General Compliance Program Guidance November 2023

On June 13, the Biden Administration released its Spring 2023 Unified Agenda of Regulatory and Deregulatory Actions, which announced its plan to propose a rule that would ban the inclusion of formaldehyde and other formaldehyde-releasing chemicals in hair smoothing or hair straightening products that are marketed in the United States. According to the announcement, the proposed rule would be promulgated by the Food and Drug Administration (FDA), which is expected to issue a Notice of Proposed Rulemaking in April 2024. The announcement is notable because it represents the first time that an administration has expressed its intent to ban the inclusion of formaldehyde in hair products, but it is not the first time that the government has explored the negative effects of formaldehyde in hair products.Continue Reading Hair Products with Formaldehyde Are Going Out of Style: Is Your Organization Ready for the Change?