Utah recently signed into law SB 227, creating the Genetic Information Privacy Act (GIPA). The law, which is anticipated to go into effect in May 2021, is aimed at protecting genetic data collected from direct-to-consumer (DTC) genetic testing companies. Companies distributing DTC tests should evaluate their current data privacy policies and practices against the obligations the new Utah law imposes on data use and protection, including user consent, data security, and access and deletion rights, to ensure they are in a position to comply with the new law.
Continue Reading New State Genetic Privacy Law Directed at Consumer Genetic Tests

On September 14, 2020, the U.S. Food and Drug Administration (FDA) released an update on the status of its Software Precertification (Pre-Cert) Program.  It is the only public update on the program in 2020.  According to the update, FDA will continue to evaluate its Pre-Cert program, which currently is only in pilot form.  Perhaps disappointing to many companies, the update did not suggest that FDA will be adding new participants to the pilot program at this time, nor did it signal that the program would be fully operational anytime soon.
Continue Reading Latest Update on FDA’s Software Pre-Cert Pilot Program

U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak.  Manufacturers, including contract manufacturers, anticipating post-approval inspections may welcome the news, given other pressing issues facing ex-US facilities (i.e., facilities located outside the US) in light of COVID-19.  Companies with planned pre-approval inspections, however, may find the news distressing.
Continue Reading FDA Postpones Ex-US Facility Inspections

The Federal Circuit Court of Appeals has just rejected the longstanding U.S. government position that the country of origin of pharmaceuticals in the context of U.S. government procurement is determined by where the active pharmaceutical ingredient (API) is made.  Acetris Health, LLC v. United States, 2018-2399, judgment of February 10, 2020.  In the Acetris case the API was made in India.  It was then shipped in bulk to the United States, where it was manufactured into tablets.  The central question in the case was whether the resulting tablets were a “U.S.-made end product” and thus qualified under the Buy American Act (BAA) to be sold to the Department of Veterans Affairs.
Continue Reading Federal Circuit Revolutionizes Country of Origin Analysis for Pharmaceuticals

This post was originally published on MD+DI.com.

As a lawyer with extensive experience in good manufacturing practice (GMP) issues, clients will ask me to review complex Quality System investigations. My clients are typically in-house counsel and, while review by Legal makes sense to a company’s in-house counsel (after all they, too, are lawyers), Quality or Manufacturing personnel often are flummoxed.
Continue Reading Tips for When to Consider Legal Review of Quality System Investigations

Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a herculean task. In an attempt to slay this proverbial hydra, the Food and Drug Administration (FDA) developed a new pilot program – the DSCSA Blockchain Interoperability Pilot (the “Blockchain Pilot”) – which aims to use blockchain to create a secure electronic, interoperable system that tracks and traces certain prescription drugs as they are distributed in the United States.
Continue Reading What’s in the Bottle? FDA Announces New Blockchain Pilot Program for Tracking Drug Distribution

In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD), which proposed a novel regulatory framework for artificial intelligence (AI)-based medical devices.  The public docket closed on June 3, 2019, and FDA received over one hundred comments from manufacturers, industry associations, and other interested parties. The comments vary in support of FDA’s framework and largely urge FDA to align with external stakeholders that are already developing industry standards and clarify the agency’s expectations under the proposed framework.
Continue Reading Medical Devices – Artificial Intelligence and Reactions to FDA’s Proposed Oversight

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication response and patient receptivity to drugs (among other things). FDA identified three genetic tests, including one called “MediMap Plus,” which was designed to provide insight into how a patient would respond to drugs used for anesthesia, cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety, and diabetes. FDA deemed the tests to be adulterated and misbranded because Inova had not sought premarket clearance.
Continue Reading FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

While the legal landscape continues to evolve in the cannabis industry, making entry into the space a potentially risky proposition,  the passage of the Agriculture Improvement Act of 2018 (the “Farm Bill”) can be a real game changer in attracting mainstream companies to the industry.

According to the Farm Bill, hemp is now exempt from the Federal Controlled Substance Act (“CSA”), theoretically making all hemp-derived cannabidiol (CBD) products, and all commercially available products derived from hemp, legal in all 50 states
Continue Reading The Farm Bill’s Impact on Hemp and CBD – and How Some States are Reacting

After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does not.  The rule changes, if implemented, would have a significant impact on the potential liability of generic drug manufacturers in product liability cases.  The proposed rule changes are being met with significant opposition from trade groups for generic manufacturers.
Continue Reading Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims