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Keeping you afloat amidst the rising sea of regulations

FDA Finalizes Guidance on Assessing New Drug Abuse Potential

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.

Under Pressure: Mobile Medical App Settles Deceptive Ad Charges

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.

Bristol-Myers Settlement Illustrates Continuing Enforcement Trend Against Allegedly Deceptive Promotion of Medical Products

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 Secret's Out: FDA Allows Drug and Device Manufacturers to Share HCEI Prior to Product Approval

Last week, FDA issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers, describing the Agency’s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 their products t

New Year…Same Rules? HHS Makes Few Changes in Recent 340B Drug Pricing Program Final Rule

The Health Resources and Services Administration, part of the Department of Health and Human Services, published a Final Rule on January 5, 2017 addressing how 340B covered outpatient drug “Ceiling Prices” are to be calculated under the 340B Drug Pricing Program, and how participating drug manufacturers may be subject to certain monetary penalties for violation of the 340B statute (the Final Rule).

FDA Regulation of HCT/Ps: What Wound Care Practitioners Need to Know

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.

US Attorney Announces Kickback and False Claims Act Settlement with Device Manufacturer BioTelmetry/MedNet

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.  

Sellers Beware: California Adopts New Proposition 65 Warning Requirements

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 Publishes First List of Pharmaceuticals for Transparency Reporting

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.

CMS Releases Covered Outpatient Drug Final Rule FAQs

On July 6, CMS issued a set of Frequently Asked Questions to respond to questions raised by the Covered Outpatient Drug Final Rule that was published on February 1, 2016.  The FAQs can be accessed here; our January 28 article analyzing the final rule can be accessed here and our analysis of the delayed implementation of the revised 5i AMP methodology and 70/30 test can be found here.