Tag Archives: Bonnie Scott

What’s New in E-Cigarette Regulation?

There is little question that youth e-cigarette use has been on the rise. In 2018, an estimated 3.6 million kids reported “current use” of e-cigarettes (defined as use on at least one day in the past 30 days), up from just 220,000 kids reporting such use in 2011 (See National Youth Tobacco Survey findings). Although youth e-cigarette use raises public health concerns, there’s also a public health upside to e-cigarettes, as they have been shown to be an effective tool in helping current adult cigarette smokers kick the habit and are a safer option for current smokers than combustible tobacco products (e.g., cigarettes).  Therefore, it seems that broad restrictions on everyone’s access to these products is probably not the solution here. So what is the answer? How do we keep e-cigarettes out of the hands of children, but maintain their availability for adult cigarette smokers? Let’s track what’s recently been done on the federal and state/local levels to address the issue.

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The Role of Patient Preference in Medical Device Evaluation

When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA regulators as the ones driving the process. But what about the patient perspective? Does that get factored in?

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Obscure FDA Device Reporting Exemptions Draw Patient and Provider Concern

Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture.  A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.

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FDA Loosens the Reins on Informed Consent Requirements for Certain Clinical Studies

Following up on its July 2017 guidance on the same topic (discussed in a previous blog post), FDA issued a proposed rule on November 15, 2018 to amend Agency regulations to allow Institutional Review Boards (“IRBs”) to waive or alter certain informed consent elements (or in some cases, waive the informed consent requirement altogether) for FDA-regulated, minimal risk clinical investigations (“Proposed Rule”).

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FCA Penalty Spike Confirmed by DOJ

Entities that provide goods and services to the federal government, including health care providers and life sciences companies, should take note of the new civil monetary penalty amounts applicable to False Claims Act (“FCA”) violations. After much anticipation, the U.S. Department of Justice (“DOJ”) issued an interim final rule on June 30, 2016 confirming speculation that the penalty amounts will increase twofold.

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