Category: Regulatory and Industry Standards

FDA Posts Draft Guidance for Pharma Companies, Sponsors, and Researchers on Using Real-World Data from Health Records in Clinical Studies

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The U.S. Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies, sponsors, and researchers sourcing Real World Data (RWD) from health records. As the FDA’s first attempt to define guidelines on sourcing RWD, the draft document provides insight into the FDA’s current thinking on the approach that companies should use to support regulatory filings for medications.

The guidance references the Framework for Real World Evidence Program, released in December 2018. The Framework is designed to regulate uses of RWD and Real Word Evidence (RWE), which are used by life sciences companies to investigate how medicines perform beyond clinical trials, and to back up clinical trial results. This draft guidance is the first of the series that have been promised by the FDA to develop the Framework. More information about the FDA Framework can be found on our blog here.

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510(k) Clearance Precludes Punitive Damages in Arizona

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We know the plaintiffs’ bar’s feelings about the FDA’s 510(k) clearance process. They tell the jury and the court it is antiquated. They say it does not constitute a finding of safety or efficacy. They do all they can to paint the FDA’s regulatory clearance process as meaningless and not worthy of consideration by a judge or jury. Such arguments may have some vitality in some jurisdictions. But, as we learned twice again in the last month, not in Arizona.

Back in 2012, the Arizona legislature passed a law stating that a manufacturer may not be held liable for exemplary or punitive damages if “[t]he product alleged to have caused the harm was designed, manufactured, packaged, labeled, sold or represented . . . according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.” A.R.S. § 12-689(A)(1). The statute broadly defined “manufacturer” to include those engaged in designing, manufacturing, or formulating a product. A.R.S. § 12-689(D)(3). And it further defined “government agency” to mean any federal or Arizona agency with authority “to issue rules, regulations, orders or standards concerning the design, manufacture, packaging, labeling or advertising of a product[.]” A.R.S. § 12-689(D)(2).

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FDA Finds Certain E-Cigarette Products “Appropriate for the Protection of Public Health” but Not “FDA Approved”

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On October 12, 2021, the U.S. Food and Drug Administration (“FDA”) issued orders granting R.J. Reynolds (RJR) Vapor Company approval to market three of its electronic nicotine delivery system (ENDS) products – the Vuse Solo ENDS e-cigarette and accompanying tobacco-flavored pods.  In issuing the orders, FDA found “that the marketing of these products is appropriate for the protection of public health.”  However, FDA also stated that its orders do not mean “these products are safe or ‘FDA approved.’”  See FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency | FDA.

Although ENDS products, such as e-cigarettes, have been on the market since the mid-2000s, this is the first time FDA has authorized the marketing of specific ENDS products through the Premarket Tobacco Product Application pathway.

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

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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.

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FDA Approves First Interchangeable Biological Product Under BPCIA

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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.

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New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal

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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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