FDA Posts Draft Guidance for Pharma Companies, Sponsors, and Researchers on Using Real-World Data from Health Records in Clinical Studies

The U.S. Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies, sponsors, and researchers sourcing Real World Data (RWD) from health records.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 This draft guidance is the first of the series that have been promised by the FDA to develop the Framework.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

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”

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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Treating Physician’s Informed Consent Process and Decision-Making in Device Selection Lead to Partial Summary Judgment for Device Manufacturer

A series of recent rulings out of the Southern District of Texas in an inferior vena cava (IVC) filter case reflect how well-planned discovery can lead to a successful multipronged summary judgment motion and can effectively prune a plaintiff’s ambitious product defect claims. Conn v. C.R. Bard, Inc., No. 4:14-CV-298.

In 2006, plaintiff’s physicians discovered a blood clot in his inferior vena cava. An IVC filter was inserted to prevent the blood clot from causing potentially fatal further injury. Because of plaintiff’s young age, the physician chose a removable filter. Plaintiff reported abdominal pain just four days after the IVC filter was placed. The blood clot was found to have moved and extended through and above the recently placed filter, and the physicians initiated anticoagulant therapy.

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New Phthalates Study Garnering Media Attention Purports to Show Only an Association – Not Causation – with Certain Mortalities

A new study regarding phthalates has garnered media attention this month, but readers should recognize the study’s limitations.  Some media coverage of this study blurs the important distinction between “association” and “causation.”

What Are Phthalates?

Phthalates, sometimes called plasticizers, are a group of chemicals generally used to make plastics more durable, or to dissolve other materials.  Phthalates may be found in products such as vinyl flooring, food wraps, intravenous tubing, lubricating oils, and some personal care products such as shampoos, soaps, and hairsprays.
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This Month in Snap Removal: The District of Nevada Muddies Its Snap Removal Waters and Throws Proponents a Life Preserver

Faegre Drinker’s snap removal team continuously monitors snap removal updates across the country (for a basic explanation of snap removal and previous updates, see Faegre Drinker’s prior posts here; for a breakdown on how each federal jurisdiction treats snap removal, see Faegre Drinker’s interactive snap removal map here).

The United States District Court for the District of Nevada is no stranger to consideration of the practice of snap removal—indeed, the District of Nevada has issued a number of decisions in 2020 and 2021, all holding that snap removal was improper unless and until at least one defendant has been served. But a recent opinion out of the District rejects the reasoning in those earlier decisions and holds that snap removal is proper even if no defendant has been served.

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