Podcast - Who Owns Your DNA? Lessons Learned from 23andMe
State AG Pulse | CT AG Reacts to Genetic Data Breach
Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...more
On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
We have written a couple of times about the 23&Me phenomenon and the chance that those who enter this unknown world come back not just surprised but possibly creeped out by their quest for ancestral knowledge. USA Today...more
Model Overview - CMS as Negotiator - Under the model, CMS will negotiate OBAs with participating manufacturers, which will tie pricing for SCD treatments to whether the therapy improves health outcomes for people with...more
Manufacturer-sponsored genetic testing programs provide several benefits to patients, including expanding access to genetic testing, providing opportunities for patients to participate in research, empowering patients to make...more
We previously alerted readers to the fact that the most recent data compromise of 23andMe exposed data related to Ashkenazi Jews and individuals of Chinese descent. It is reported by Ars Technica, citing TechCrunch, that...more
The Federal Trade Commission recently published a blog post regarding the privacy of DNA. What do you need to know? •Protecting biometric information – including genetic data – is a top FTC priority. (See FTC Biometric...more
In October of 2023, a hacker claimed online that they had 23andMe users’ profile information. We know this as a result of 23andMe’s required statement to the U.S. Securities and Exchange Commission (SEC) on December 1, 2023. ...more
Earlier today, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics for their CRISPR/Cas9 gene therapy, CASGEVY...more
On September 25, California Attorney General (AG) Rob Bonta announced a settlement with Biora Therapeutics, Inc. (Biora) regarding misleading claims the company made concerning the cost of its genetic testing services. Under...more
Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more
After decades of intense scientific research into developing gene editing technologies, and more than a few setbacks, the field has produced a number of success stories in recent years, demonstrating that regulatory agencies...more
A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more
In the FTC’s first case focused on the privacy and security of genetic information, the FTC alleges that San Francisco-based Vitagene, Inc. – now known as 1Health.io – failed to live up to its promises and unfairly changed...more
China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more
Genetic testing is a burgeoning area of preventative and predictive medicine. Such testing enables greater insight into a patient's unique genetic makeup and, in turn, more tailored and individualized medical decisions....more
China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“MOFCOM”) issued the proposed amendment to...more
The proliferation of genetic testing, where you buy a kit and then send away saliva or scrapings from your cheek, to get your genetic history has certainly lead to many unintended consequences....more
The investments in Advanced Medicinal Products (ATMPs) that use gene therapy, somatic cell therapy, and engineered tissues for preventing, treating, or curing human diseases probably represent the biggest innovation in the...more
An international cadre of scientists* from almost 70 institutions worldwide recently reported their findings in the scientific journal Nature that the domesticated dog (Canis familiaris) arose from two populations of...more
As gene editing techniques come to the fore in the UK and elsewhere, industry increasingly needs clarity on the breeder's exception to plant variety rights. Originally published on IAM media.com on May 2022....more
I have written about genetic testing kits before, but this subject matter is worth repeating. I find that people don’t always understand the consequences when sending a swab to a genetic testing company. Consumer Reports...more
Last month, California Governor Gavin Newsom signed Senate Bill 41, the Genetic Information Privacy Act (“GIPA”), a law that regulates “direct-to-consumer genetic testing companies” that handle the “genetic data” of...more
Florida recently passed a law governing DNA samples. The Act places several restrictions on the use, retention, and sharing of DNA samples. Those that violate the Act may face criminal liability....more