FDA Law Update

Current Issues Affecting FDA-Regulated Companies

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…
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.…
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…
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.…
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…
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…
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.…
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…
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…
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.…