FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule will go into effect on September 1, 2021.

The new rule may provide an end to a years-long process on knowledge-based labeling directives in the old regulations. Proposed amendments to clarify the “intended use” regulations began in 2015, which we discussed previously.

Continue reading

FDA Approves First Interchangeable Biological Product Under BPCIA

On July 28, the FDA approved the country’s first interchangeable biosimilar product. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine).

Under the Biologics Price Competition and Innovation Act (BPCIA), biological products (e.g., vaccines and therapeutic antibodies) may come to market by showing that they are “biosimilar” to or “interchangeable” with a “reference product,” which is a biological product that has already been approved by the FDA. A biological product is “biosimilar” if it is “highly similar to the reference product notwithstanding minor differences in clinically inactive components” and “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” 42 U.S.C. § 262(i)(2). To date, 28 biological products have been approved as biosimilars.

Continue reading

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.

Continue reading

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.”

Continue reading

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?”

Continue reading

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:

Continue reading