The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs designated as Competitive Generic Therapies. The FDARA, according to FDA commissioner, Scott Gottlieb, “is part of our broader effort to foster generic competition and help address the high cost of drugs […] key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.”
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On June 25, 2018, the Food and Drug Administration (“FDA”) approved Epidiolex (cannabidiol), the first marijuana derived drug for use in the United States, to treat two rare forms of epilepsy. This decision for the FDA could have sweeping effects for the marijuana industry. While the FDA has previously approved drugs comprising synthetic (manufactured) cannabinoids,

On May 3, 2018, the U.S. Department of Agriculture (“USDA”) released its much-anticipated proposed rule to establish a national standard for the disclosure of bioengineered ingredients in certain food products. The public comment period on the proposal has begun and runs through July 3, 2018. The proposed rule sheds light on certain aspects of the

Seyfarth Shaw is pleased to announce The BioLoquitur Bulletin: Drugs Available in 2018 for Generic Competition, published by the Life Sciences team. The BioLoquitur Bulletin provides a brief overview of selected New Chemical Entities (NCE) that were approved by the FDA in the year 2014. While not every NCE will be a target for

The Food and Drug Administration (FDA), as part of its Drug Competition Action Plan, published a draft guidance detailing good practices for the submission of ANDAs on January 3, 2018. The guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA and makes recommendations to applicants on how to avoid such deficiencies. A typical ANDA requires an average of four review cycles before approval. The delay happens when ANDAs are submitted without all the information that the FDA needs to determine whether the ANDA meets FDA standards for approval, which leads to additional review cycles.
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In a few short days, the United States will mark the eight-year anniversary of the Biologics Price Competition and Innovation Act (“BPCIA”). Signed into law on March 23, 2010, the BPCIA creates a regulatory pathway for the approval of biosimilar drugs in the United States and a mechanism, albeit voluntary, for resolving patent right disputes relating to the innovator biologic products. 
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U.S. Food and Drug Administration (FDA) Commissioner, Dr. Scott Gottlieb, has made generic drugs and drug pricing an agency priority by emphasizing the critical value of generic drugs to public health. In 2017, 1027 total generic drugs were approved, which was the highest number of generic drugs approved in a single year.[1] Table 1 below illustrates 2017 approvals by month.
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On December 7, 2017, the FDA announced three new policy documents geared toward advancing and properly overseeing innovative new digital health tools. The documents mark an acute recognition by the FDA that as consumers and health care providers increasingly use digital technologies as health tools to acquire information, the FDA’s policies must continue to encourage

The ability to facilitate the regeneration of parts of the human body is “no longer the stuff of science fiction” according to FDA Commissioner Scott Gottlieb.[i] According to Commissioner Gottlieb, the cell based therapies and their use in regenerative medicine is one of the most promising fields of science already producing “improbable advances.” At