Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting cost-sharing subsidies for life-saving oncology drugs. In October, we discussed the Office of Inspector General’s (“OIG”) Advisory Opinion No. 22-19 (the “Advisory Opinion”), which declared that a charitable organization funded by manufacturers would violate the AKS if it offered certain cost-sharing subsidies under Medicare Part D (“Part D”), even if the organization was independently run and patients had equal access to discounts for 90% of drugs on the market. On November 9, 2022, the Pharmaceutical Coalition for Patient Access (“PCPA”), presumably the organization behind the Advisory Opinion, filed a lawsuit against OIG, seeking declaratory judgment that its cost-sharing program is legal under the AKS and that the Advisory Opinion violates the Administrative Procedure Act (“APA”) and the First Amendment.Continue Reading Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS
Dominick DiSabatino is a partner on the Life Sciences team in the firm's Washington, D.C. office.
On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries via 501(c)(3) charities without running afoul of the Federal Anti-Kickback Statute (the “AKS”).Continue Reading OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies
Providing further clarification to drug manufacturers about specific costs that can be charged for investigational drugs used in clinical and expanded access trials.Continue Reading Charging for Investigational Drugs Under an IND Questions and Answers, Draft Guidance for Industry, August 2022
On July 15, 2022, the Food and Drug Administration (FDA) issued its final guidance on developing the content and format of patient Instructions for Use (IFU) for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The final guidance, issued over three years after the draft guidance, provides FDA’s expectations for the content and format of IFUs so that they are consistent across drug and biological products. The FDA’s final guidance does not modify its draft guidance in any major substantive way. Rather, as stated by the FDA, the final guidance merely includes “editorial changes to improve clarity.”Continue Reading FDA Issues Final Guidance on Drug and Biological Instructions for Use (IFU)
On June 2, 2022, the US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter  to Althera Pharmaceuticals, LLC (Althera) relating to promotional communication for ROSZET® (rosuvastatin and ezetimibe) tablets for oral use (Roszet). The promotional communication was a professional “Roszet Doctor Info Letter Size”.  This is the third untitled letter from OPDP this year. In January, OPDP sent an untitled letter to Eli Lilly & Company regarding promotional claims for TRULICITY® on social media. In March, OPDP sent an untitled letter—which we covered in our blog post here —to Bausch Health Companies for misleading statements for DUOBRII™ conveyed in a promotional video and healthcare professional website.Continue Reading FDA Issues Untitled Letter to Althera Pharmaceuticals for Statements Relating to ROSZET®
On March 31, 2022, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an untitled letter to Bausch Health Companies Inc. regarding a promotional video and healthcare professional website for DUOBRII™ (halobetasol proprionate and tazarotene) lotion, indicated for topical treatment of plaque psoriasis in adults (DUOBRII). The video content aired on a popular television network and the website content was directed at healthcare professionals. This is only the second untitled letter from OPDP this year, both of which were focused on false and misleading promotional messaging.
Continue Reading FDA Issues Untitled Letter to Bausch Health Companies for Misleading Statements Relating to DUOBRII™
On Thursday, March 16, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued OIG Advisory Opinion (“AO”) No. 22-05, relating to subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial involving medical devices (the “Proposed Arrangement”). This is the third AO in a recent series of AOs (see AO 21-17 on November 19, 2021 and AO 21-13 on October 4, 2021) focused on Medicare cost subsidies in a clinical trial setting for serious conditions that affect large portions of the population in the US. Like these other AOs, OIG found that while the Proposed Arrangement could generate fraud and abuse risks under both the Federal anti-kickback statute (i.e., Section 1128A(a)(7) and 1128B(b) of the Social Security Act (“Act”)) and the Beneficiary Inducements CMP (i.e., Section 1128A(a)(5) of the Act), the Proposed Arrangement nevertheless presented a minimal risk of fraud and abuse under the law on the facts presented. Medical device manufacturers should pay close attention to this trend when considering trial designs and patient populations.
Continue Reading OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers