FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

By Allison Fulton and Kenneth Yood on April 22, 2019 Posted in FDA

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 Update: Recent Trends and a New Regime

By Allison Fulton on April 19, 2019 Posted in Miscellaneous

Norman E. (Ned) Sharpless, M.D., recently took the helm as Acting Commissioner of the US Food and Drug Administration (FDA). Dr. Sharpless most recently served as the director of the National Cancer Institute, part of the National Institutes of Health (NIH), which serves as the government’s principal agency for cancer research. Dr. Sharpless’s appointment comes on the heels of the resignation of former Commissioner Scott Gottlieb, M.D. on April 5, 2019. Continue Reading

The Farm Bill’s Impact on Hemp and CBD – and How Some States are Reacting

By Andrea Cataneo on March 12, 2019 Posted in FDA, IP and Technology Transactions, Miscellaneous, Tobacco

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

WARNING: Prop 65 Has Changed – If Your Product Is Sold In California Or You Do Business In California, Pay Attention

By Whitney Jones Roy and Jeffrey Parker on January 18, 2018 Posted in Miscellaneous

What is Prop 65?

Prop 65 is a California law that requires California consumers receive warnings regarding the presence of chemicals that cause cancer or reproductive toxicity. The law is highly technical, constantly evolving and actively enforced by the government and private enforcers. Continue Reading

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

By Bradley Graveline on October 14, 2016 Posted in FDA

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.

Forget About Vermont!: Congress Passes GMO “Labeling” Legislation

By Peter Reichertz on July 19, 2016 Posted in FDA

On July 14, 2016, the House of Representatives passed S.764 creating a National Bioengineered Food Standard. Importantly for food manufacturers and distributors, the law – expected to be signed by President Obama – will preempt all state laws “relating to the labeling or disclosure of whether a food is bioengineered or was developed or produced using bioengineering” if that standard is not identical to the mandatory disclosure under the new federal standard. Once enacted, the law will preempt the Vermont GMO labeling Act that went into effect July 1, 2016.

Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

By Jesse Salen on January 19, 2016 Posted in Biotechnology, FDA, Legislation

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious. See 35 U.S.C. §§ 102 and 103. Thus, innovative step-improvements to, and new applications of, existing technology may be patentable. Moreover, these step-improvements may prove lucrative, particularly when the underlying technology has entered the public domain, e.g., due to the expiration of the original patents. This concept is illustrated time and time again in the pharmaceutical industry where companies therein typically pursue competitive advantages by attempting to extend the patentable life of key technologies. One recent story illustrating this point was amplified in recent news when the FDA cleared a new pill produced by Aprecia Pharmaceuticals—the first pill of its kind produced using patented 3D printing technology. Continue Reading

What’s in a Name? That Which We Call a Biological Product…

By Peter Reichertz on August 28, 2015 Posted in Miscellaneous

The FDA has been gradually issuing guidances to implement the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). One of the most eagerly awaited guidance documents has been that on nonproprietary names to be used for biosimilar products. On August 28, 2015, the FDA finally issued its draft “Guidance for Industry: Nonproprietary Naming of Biological Products” (“the draft Guidance”). The draft Guidance will apply to all newly licensed and previously licensed biological drug products approved under Sections 351(a) and (k) of the Public Health Service Act (“PHSA”), except those for which a nonproprietary name is provided in 21 C.F.R. Part 600 and certain other biologic products “for which there are well-established, robust identification and tracking systems to ensure safe dispensing practices and optimal pharmacovigilance.” See 80 Fed. Reg. 52296 (August 28, 2015). Continue Reading

FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to FDA Oversight and Enforcement?

By Carrie Ross on February 18, 2015 Posted in Enforcement Actions, Miscellaneous

On February 09, 2015, the FDA issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that (1) meet the definition of medical devices under section 201(h) of the Federal Food Drug and Cosmetic Act, and (2) could pose a risk to a patient’s safety if the app did not function as intended. The FDA will not exercise authority over apps that are not medical devices under section 201(h), nor will it enforce its rules and regulations against the numerous apps that meet the definition of medical devices but present only minimal risk to consumers or patients.

FDA Issues Guidance for Low-Risk General Wellness Products

By Stephanie Zeppa and Andrew Kreider on January 23, 2015 Posted in Enforcement Actions, Legislation, Miscellaneous

On January 20, 2015, the FDA issued draft guidelines[1] designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as medical devices under Section 201(h) of the Food Drug & Cosmetics Act (the “Act”) and are therefore subject to the Act’s regulatory requirements for devices.

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