In creating the federal judicial branch, the Framers of the US Constitution did not intend that courts would right every possible wrong. Article III authorizes federal courts to resolve “Cases” and “Controversies.” The US Supreme Court has interpreted that power to mean that civil-litigation plaintiffs must prove they suffered an “injury in fact,” which is concrete and particularized, and not speculative. We’ve discussed Article III standing jurisprudence here in numerous contexts, most frequently in consumer class actions targeting food labels or data-security breaches, areas where the ever-amorphous concept of “economic harm” is often alleged. A March 6, 2017 Seventh Circuit decision, Eike v. Allergan, Inc. et al., shot down an especially outlandish attempt to expand standing based on an alleged economic injury. Continue reading
The Food and Drug Administration (FDA) faces a difficult balancing act in its role as the federal regulator of drug and medical-device manufacturers. On the one hand, it is charged with ensuring that medical products are both safe and effective for their intended uses. On the other hand, it must avoid imposing overly stringent regulations, lest it harm public health by blocking or delaying access to life-saving products, or to truthful information about those products.
Through its public-interest litigating, publishing, and communications capabilities, Washington Legal Foundation has long been at the forefront of efforts to ensure that FDA maintains the proper balance. Those activities have generated an impressive body of material that would be instructive for new FDA leadership to review. We provide a summary of and links to those documents below (limited to WLF’s FDA-related work product in the past several years) to simplify access to that work product. Continue reading
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