Location Matters – Manufacturing Insights from FDA’s Annual Report on Drug Quality

The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) within the US Food and drug Administration (FDA) published its annual “Report on the Sate of Pharmaceutical Quality” last week. The yearly report reviews the quality of drug products during the prior year, as measured by recall and product defect information, site inspections of manufacturers, and other post market data. The report provides a few insights that companies may want to consider when working with, or acquiring, contract manufacturers.   Continue Reading

AAFCO Issues Updated Guidelines Regarding Hemp in Animal Food

On May 1, 2019, AAFCO provided updated guidelines regarding the use of hemp in animal food, including how this market is affected by the Agricultural Improvement Act of 2018 (the “Farm Bill”). Although the AAFCO is not a government agency, its members are government agencies that represent the 50 states, the US Food and Drug Administration (FDA) Center for Veterinary Medicine, and the Canadian Food Inspection Agency.  Continue Reading

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

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

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

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 statesContinue Reading

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

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

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.

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

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.

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

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…

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

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