Category: Regulatory

EU Publishes General Product Safety Regulation – Full Enforcement to Commence in December 2024

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On May 23, 2023, the European Commission formally published the new General Product Safety Regulation, which reforms a variety of product safety regulations for manufacturers doing business in the European Union (EU) and its 27 member states. The European Parliament adopted the text of the regulation on March 30, 2023, and the European Council adopted it on April 25, 2023, but its official publication yesterday triggers the implementation and enforcement deadlines. Specifically, the regulation takes effect on June 12, 2023 (20 days from yesterday) and will include an 18-month transitionary period for EU member states, companies subject to the regulation and other actors to implement the new and revised regulations. Full enforcement begins December 13, 2024, after the conclusion of the transition period.

The regulations have been under consideration for many years and represent a major overhaul of product safety regulation in Europe. Product manufacturers should review the full set of regulations carefully and make any necessary adjustments to their procedures and processes to be in compliance with the new regulations before full enforcement takes effect on December 13, 2024. Among other things, the new General Product Safety Regulations include new requirements related to adverse event reporting, pre-market risk assessments, safety recalls, and product labeling and documentation. For example, manufacturers will be required to report “accidents caused by a product” “without delay” if the product is involved in an incident resulting in death or “serious adverse effects on health and safety.” Meanwhile, operators of online marketplaces are subject to an even more broadly worded requirement to report “accidents caused by a product … resulting in serious risk or actual damage of the health or safety of a consumer,” which extends the reporting requirement beyond incidents of actual injury.

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It’s All Up in the Air: Recent Moves to Ban or Limit Natural Gas Appliances

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Citing the effects of carbon emissions on climate change and the potential for health risks, efforts to electrify America’s natural gas infrastructure are underway in various markets. Natural gas comprises primarily methane. Indoor appliances like gas stoves are also associated with emissions of nitrogen dioxide and carbon monoxide. The electrification efforts are making an impact at local, state, and federal levels.

At a local level, cities including Berkeley in 2019, San Francisco in 2020, and New York City in 2021, have banned certain natural gas hookups in all new building construction. San Francisco’s 2020 legislation applied to new residential and commercial building construction and required use of all-electric power. The ordinance was estimated to cover about 60% of the city’s development pipeline. It followed a similar ordinance requiring all-electric construction for new municipal projects in San Francisco.

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The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

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Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show no sign of slowing, as the number and type of medical device products that are connected to the cloud increase (thereby increasing the attack surface for hackers), and as hackers become more sophisticated. Indeed, in a September 2022 FBI Private Industry Notification, the FBI noted that around 53% of connected medical devices and other internet of things (IoT) devices in hospitals had known critical vulnerabilities. These vulnerabilities could allow hackers to direct medical devices to give inaccurate readings, administer drug overdoses, or otherwise endanger patient health.

In the past, the U.S. Food & Drug Administration (FDA) has urged manufacturers to take measures to ensure the cybersecurity of their products through non-binding guidance. On December 29, 2022, President Biden signed into law the $1.7 trillion Omnibus Appropriations Act, which provided the FDA with authority to require manufacturers to take cybersecurity protection measures as to medical devices that are brought to market through future pre-market submissions. See H.R. 2617 (117th Congress, 2021-2022), text available here.

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5 Major Drug and Device Developments of 2022

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As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.

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Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape

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Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device manufacturing, drug discovery and manufacturing, industrial manufacturing, smart home and wearable devices, and vehicles. AI has the potential to benefit society in a number of ways, including by boosting efficiency, providing invaluable insights, and informing decisions. But to borrow from the likes of Winston Churchill (or Spider-man), with great AI capabilities comes great responsibility.

Many of the risks and benefits of AI systems are unique in comparison to other technologies. Regulators, governmental agencies, and consumer advocates are keenly focused on addressing unintended consequences that may result from the development and use of algorithms and AI. These issues, like the technology, are complex, and policymakers, stakeholders, and regulators are grappling with how best to address them.

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Updated EPA Analysis on Long-Term Health Effects of Formaldehyde Exposure Could Have Lasting Implications for Manufacturers

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On April 14, 2022, the Environmental Protection Agency (EPA) released draft conclusions in a report updating its analysis regarding formaldehyde exposure, suggesting that long-term exposures to small amounts of formaldehyde in the environment can increase the risk of rare head and neck tumors, leukemia, and other threats to health. The conclusions are not final agency action. Still, manufacturers should be aware of the potential for EPA’s analysis to influence both regulation and litigation at both the state and federal levels.

For over a decade, there has been much debate and study on the long-term effects of exposure to formaldehyde. The EPA’s new analysis is an update of a 2010 draft EPA report that was heavily panned by scientists, legislators, and chemical manufacturers and that drove the EPA back to the drawing board. For example, the National Academies of Sciences, Engineering, and Medicine criticized the 2010 draft EPA report for failing to describe the rationale behind its methodology and failing to sufficiently support its conclusions.

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