Susan E. Dudley is Director of the George Washington University Regulatory Studies Center, which she founded in 2009, and a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. From 2007 to 2009, she served as the Administrator of the Office of Information and Regulatory Affairs (OIRA) in the U.S. Office of Management and Budget.
WLF Legal Pulse: As promised, Congress and the Administration have quickly gotten to work reconsidering and removing a host of federal regulations while also setting the stage for a much different approach to regulation. Let’s first talk about what Congress is doing.
Professor Dudley: Under the Congressional Review Act of 1996 (CRA), Congress has 60 legislative days after a regulation is published to vote to disapprove it. The procedures for disapproval are streamlined (including requiring a simple majority in the Senate) and if a rule is disapproved, the agency cannot issue something substantially similar. Continue reading
Partially hydrogenated oil
In 2016, class-action lawsuits alleging that a processed food product or its labeling violated state consumer-protection laws continued to clog the federal courts, especially in California. The number of new food-related consumer class actions filed last year nearly equaled the number filed in 2015, according to a report in Food Navigator USA. It’s unclear whether these trends will hold in 2017, but there is one set of blatantly frivolous claims that should disappear this year: those that seek judicial regulation of products that contain partially hydrogenated oil (PHO), the main source of trans fat. A December 13, 2016 Southern District of California decision should frustrate such claims in the short term, and a forthcoming US Court of Appeals for the Ninth Circuit decision in a pending case may (and should) end them permanently. Continue reading
Today, the US Food and Drug Administration (FDA) will hold a long-awaited public meeting to consider how off-label information about medicines can be shared with physicians. Washington Legal Foundation staff attorney Greg Herbers will testify at the meeting, which FDA has entitled “Communications Regarding Unapproved Uses of Approved Medical Products.”
Since WLF’s landmark victories in the Washington Legal Foundation cases, courts have consistently upheld the First Amendment right to communicate truthful and non-misleading information about the off-label uses of medical products. For instance, in US v. Caronia, WLF represented an industry employee convicted of discussing a drug’s off-label benefits and won a reversal from the US Court of Appeals for the Second Circuit on First Amendment grounds. WLF filed an amicus brief in a second case, Amarin Pharma v. FDA, in which a US federal district court followed the rationale of Caronia. Those decisions presumably played a major part in FDA’s decision to reevaluate its approach to off-label communication.
The text of WLF’s testimony is available here. WLF will also submit written comments to FDA in December.
Because “public-interest” groups cloak themselves with the feel-good mantle of protecting consumers, the environment, animals, etc., the motives of such groups rarely get questioned. But several recent developments show that all too often, activists put their own self-interest before the public’s interest.
Consider, for example, environmental groups’ opposition to a Washington state ballot measure going before voters this fall. Initiative 732 pursues a major environmentalist goal—carbon-emissions reduction—by imposing an excise tax. Revenues from the carbon tax would in turn fund sales, manufacturing, and low-income-household tax cuts. In other words, it’s revenue neutral, and that doesn’t sit well with green activists who see climate change as an effective proxy for a broader ideological goal: expanding government. Continue reading
Four members of the Senate Health, Education, Labor, and Pensions Committee (HELP), including Chairman Lamar Alexander, wrote Food & Drug Administration (FDA) Commissioner Robert Califf earlier this month to reiterate their concerns with FDA’s use of guidance as regulatory tool. Members of the committee had previously written the FDA Commissioner about the agency’s use of guidance in May 2014, to which FDA responded nearly a year later in March 2015. During his confirmation hearing before the HELP Committee last November, Commissioner Califf addressed several questions about the use of guidance and pledged to investigate the Senators’ questions. Continue reading
By Matthew A. Reed, Sedgwick LLP
“Impossibility preemption,” the US Supreme Court has warned, “is a demanding defense” to a state tort claim for failure to warn about the risks of a prescription drug. Wyeth v. Levine, 555 U.S. 555, 573 (2009). It is not, however, impossible to prove. Indeed, the Utah federal district court on March 16, 2016 acknowledged in Cerveny v. Aventis, Inc. two ways by which a prescription drug manufacturer may prove the impossibility of complying with conflicting state law and federal regulations. Continue reading