In a Federal Register notice scheduled to be published on March 20, 2017, the Health Resources and Services Administration (HRSA) announced that it will delay the effective date of the January 5, 2017 final rule (the Final Rule) that provided guidance on the calculation of drug ceiling prices and the imposition of civil monetary penalties on certain drug manufacturers participating
Pharmaceutical & Device Compliance
The pharmaceutical and medical device industries are increasingly subject to intense government scrutiny. Arent Fox helps these companies navigate the rough waters by providing fraud and abuse risk assessments related to the sales and marketing of prescription drugs and medical devices under both federal and state fraud and abuse laws, as well as compliance program development, monitoring, auditing, and training tailored for the drug and device arena. We assist with “Sunshine Act” compliance, both under the federal Physician Sunshine Act and under state laws mandating reporting of advertising and marketing costs. We counsel companies related to all forms of patient assistance programs, including free goods, charities, and manufacturer-sponsored “coupon” or co-payment assistance programs. We also track state law developments relating to price reporting, registering of clinical trials and reporting of trial results, limitations on prescription data-mining and licensing or other oversight of field sales representations.
Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.
Last week, FDA issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers, describing the Agency’s expectations for drug and device manufacturers’ communication of health care economic information (HCEI) about
This article was originally published in Today's Wound Clinic.
Editor’s Note: The following article discusses products characterized as “cellular and/or tissue-based products” (CTPs) by ASTM International. For purposes of this article, the legal and regulatory definition “human cells, tissues, and cellular- and tissue-based products” (HCT/Ps) – is used.
Once again, a mobile medical app manufacturer has been caught in the Federal Trade Commission's enforcement web as a result of allegedly deceptive ad practices. Earlier this week, the FTC announced that Aura Labs, Inc. (doing business as AuraLife and AuraWare) agreed to settle charges that Aura violated the FTC Act by deceiving consumers with claims that its “Instant Blood Pressure (IBP)” app was as accurate as a traditional blood pressure arm cuff.
Late last week, the Attorneys General of 43 states announced that they reached a $19.5 million dollar agreement with Bristol-Myers Squibb Company to settle allegations that the company engaged in deceptive trade practices with respect to the marketing of a drug intended for treating schizophrenia.
The US Attorney’s Office for the District of New Jersey recently announced an agreement with BioTelemetry Inc. to settle allegations that its recently-acquired subsidiary, MedNet, Inc., violated the Anti-Kickback Statue and False Claims Act by improperly inducing health care providers to use the company’s cardiac monitoring services.
On August 31, 2016, California took a long-awaited step in publishing new major changes to the Proposition 65 warning regulations; the first of such amendments in more than a decade. The wholesale changes completely alter the “safe harbor” warning rules, creating a new set of obstacles for companies offering products or operating facilities in California. Although the new regulations are intended to increase clarity and decrease litigation, they may actually have the opposite effect.
Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports. The list is available on the Vermont Office of Attorney General website. Prescribed forms are available for reporting there as well. Reports are due on or before October 1, 2016.
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Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.