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Keeping you afloat amidst the rising sea of regulations

FDA Authorizes First Direct-to-Consumer Genetic Test for Cancer

On March 6, 2018, the US Food and Drug Administration issued an authorization letter to 23andMe, Inc. that permits marketing of the company’s genetic test for use in screening consumers for select BRCA1/BRCA2 breast cancer gene mutations that are most commonly found in people of Ashkenazi (Eastern European) Jewish descent.

Wait a Sec, I’ve Got a Text: CMS Clarifies Position Regarding Texting of Patient Information

On December 28, 2017, the Centers for Medicare and Medicaid Services (CMS) issued Survey and Certification Memorandum Number 18-10-ALL to the State Survey Agencies clarifying its position regarding texting health care information by providers. Such clarification was needed: CMS’s individual guidance about texting had been uneven in 2017, with reports that CMS informed some facilities that texting any patient information was prohibited.

FDA Issues Comprehensive Tissue Product Regulatory Framework

On November 16, 2017, FDA announced a comprehensive regenerative medicine policy framework to provide additional clarity regarding existing and future tissue regulation. This framework includes a final guidance document establishing FDA’s interpretation of integral terms relating to regulation of certain tissue products, as well as draft guidances regarding the statutory designation of regenerative medicine advanced therapies (RMATs) authorized under the 21st Century Cures Act.

Just in Time for the Holidays: California Agencies Propose Emergency Regulations for Temporary Cannabis Licenses

With less than 45 days until the January 1st implementation of Proposition 64 (the proposition that legalized cannabis in California) and the effective date for the Medicinal and Adult-Use Cannabis Regulation and Safety Act (an act that regulates cannabis), the California agencies given licensing authority under the law posted their proposed emergency regulations for commercial medicinal and adult-use cannabis.

HOPPS 2018 Final Rule Released, Confirming Changes to Medicare Part B Drug Reimbursement for Drugs Purchased Under the 340B Program

The advance copy of the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (HOPPS) final rule for calendar year 2018 (the Final Rule) was released on November 1, 2017. The official version of the Final Rule will be published in the Federal Register on November 13, 2017.

California Bans Inquiries Into Applicant’s Salary History, “Bans the Box” On Criminal History Inquiries

California Governor Jerry Brown signed two major pieces of legislation affecting the application and hiring process for nearly all employees. AB 168 prohibits employers from seeking salary history information about an applicant for employment, among its related provisions. AB 1008 “bans the box” on employers’ applications asking about criminal conviction history. Instead, employers will be able to inquire into, and consider, an applicant’s conviction history only after making a conditional offer of employment.

California State and Local Cannabis Rules Take Different Paths

Over the past month, California has been a veritable hotbed of activity regarding the regulation of cannabis for both medical and adult use. Most notably, on June 27, Governor Jerry Brown signed into law the Medicinal and Adult-Use Cannabis Regulation and Safety Act to harmonize and reconcile the state’s requirements for medical and adult use, which previously imposed different standards based on the cannabis’ use.

FDA and Duke University to Explore Expanded Use of Real-World Evidence for Drugs in Public Workshop

On September 13, 2017, FDA and the Duke-Robert J. Margolis, MD Center for Health Policy will bring stakeholders to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and decision making. Topics in general will include an update on FDA’s activities to address the use of RWE in regulatory decision and development of a framework for handling challenges related to accepting RWE. Panelists are expected to discuss opportunities to improve data development activities, study designs, and analytical data to create robust RWE.