New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal

Overview

The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction to block the FDA from withdrawing a longstanding enforcement policy regarding homeopathic drug products.

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CPSC’s Expanding Role under the Biden Administration

During the Trump administration, the number of consumer product safety recalls fell for three years in a row. When Robert Adler became Acting Chair of the U.S. Consumer Product Safety Commission (CPSC) in 2019, he compared his role to that of a caretaker. Now, under the Biden administration, the CPSC is undergoing a shift toward increased regulation and more aggressive enforcement. Acting Chair Adler confirmed the same earlier this year, stating that the Biden administration “clearly views product safety in different terms,” and that he “plan[s] to modify [his] job’s metaphor from caretaker to gardener.”

This shift in thinking is evident in the CPSC’s actions in recent months. Since President Biden’s inauguration, the CPSC has announced 57 product recalls in addition to a $7.95 million civil penalty settlement with Cybex International, Inc. for alleged failure to immediately report a known product safety defect related to its exercise equipment. And on April 17, the CPSC issued an urgent warning to consumers to stop using the Peloton Tread+ exercise machine around small children or pets. The CPSC noted that though its investigation of reported incidents of injury or death related to the machine was still ongoing, it had “found that the public health and safety requires this notice to warn the public quickly of the hazard.”

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Pushing Back Against the CPSC – Is a Mandatory Recall on the Horizon for Peloton’s Treadmills?

The U.S. Consumer Product Safety Commission (CPSC) and Peloton Interactive, Inc. (Peloton) are clashing over whether the media, technology, and fitness company should issue a recall of its treadmill, the Peloton Tread+.  The disagreement came to a head on Saturday, April 17, when the CPSC and Peloton issued competing statements after failing to agree on language to be used in a joint announcement regarding the Tread+.  This dispute raises the question, “What now?”

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FDA Announces Increased Inspections and Enforcement Actions, Additional Guidance to Reduce Toxic Elements in Food for Babies and Young Children

On March 5, 2021, FDA issued a public statement announcing regulatory actions to reduce toxic elements — with a particular focus on arsenic, lead, cadmium and mercury — in food for babies and young children. FDA cited the risk heavy metals pose to infant and young children’s neurological development. The Agency indicated that it would take the following actions:

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SCOTUS Denies Certiorari in Cases Concerning FCA Liability Requirement, Objective Falsity Circuit Split Remains Intact

The United States Supreme Court denied certiorari without comment in two cases seeking to resolve a Circuit split regarding the proof required to establish that a claim for payment was false or fraudulent under the False Claims Act.

Two Petitioners asked the Court to decide whether the False Claims Act, 31 U.S.C. §§ 3729-3733, requires proof of “objective falsity”, or whether a plaintiff expert’s opinion that differs from the judgment of the defendant is sufficient to show a claim for payment was false or fraudulent under the FCA.  Both cases involved allegations that a physician’s certification of medical necessity for hospice services was false, and therefore sufficient to prove plaintiffs’ FCA claims.

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FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics license applications (BLAs) for biosimilar and interchangeable products, and for other parties interested in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This new guidance aims to further facilitate the development of proposed biosimilar products and proposed interchangeable products.

The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. This newly released draft guidance is the third FDA question-and-answer guidance on the BPCI Act, with the previous two released in December 2018: Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).

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