The most remarkable thing about the D.C. Circuit’s recent opinion in Safari International Club v. Jewell is that there was any opinion at all. Its blackletter law holdings on standing, final agency action, and exhaustion are the type often found in unpublished decisions. Yet the case is interesting for two reasons. The first is the glimpse it gives into an agency’s willingness to make borderline frivolous procedural arguments to evade substantive judicial review. And the second is the unqualified rejection a panel of judges not known for their skepticism of the administrative state gave to them. As a result, the case is simultaneously distressing and refreshing. It is both a reminder of how procedural complexity can empower bureaucrats and of how panel composition is not necessarily outcome‑determinative in administrative law. [Read More]
Whether legitimacy, democracy, accountability, non-partisanship, or separation of powers motivates the sentiment, there are a number of ways, albeit controversial, to reform the federal regulatory state:
(1) Codify the principle in McGrain v. Daugherty (1927) as it applies to regulatory decision-making, forcing agencies to publish jurisdictional statements in the federal register prior to beginning investigations or enforcement actions. This would have avoided many of the due process issues at the center of theLabMDcase. [Read More]
In a case of first impression in the Third Circuit, the court was called on to interpret the statutory definition of "investment adviser" and the precise scope of what "for compensation" means under the Investment Advisers Act of 1940. The issue rose in the appeal of a criminal conviction for selling phoney promissory notes and then squandering the investors' money. At sentencing, the defendant received an upward enhancement under the sentencing guidelines when the lower court found he qualified as an "investment advisor." [Read More]
Imagine you own a plot of land. You may want to build a house on the site. You may want to sell the property. Or, you may want to develop the parcel for some other purpose. As you begin to move forward with your plans, you realize part of the property contains wetlands or a small creek traverses the site. If the wetlands or creek are considered to be within federal Clean Water Act (CWA) jurisdiction, you will need to obtain permission from the federal government before disturbing your land.
With other laws it is relatively easy to recognize when you need permission from the government; one needs a driver’s license to operate a vehicle or a liquor license to sell alcohol. When it comes to developing your property, however, the reach of the CWA is “notoriously unclear." Many “wetlands” that qualify for federal protection are not at all like swamps. A wetland may exist even if it is never wet at the surface; the water table need only rise to within 12 inches of the surface a few days each year. The noticeable boundary of a wetland or small creek will change between seasons and may adjust overnight depending on precipitation. “[T]he transition from water to solid ground is not necessarily or even typically an abrupt one . . . [w]here on [the] continuum to find the limit of ‘waters’ is far from obvious." [Read More]
It’s a shame that in a nation that prizes free speech, the government routinely censors the communication of valuable and truthful information that could help save people’s lives. But it’s a fact. Federal law strictly limits how pharmaceutical companies – those with the most knowledge about drugs and their possible uses and side effects – can share information about the legal "off-label" use of their products.
Last week, the FDA once again thwarted efforts to establish clear guidelines by entering into a settlement agreement in the Amarin case involving free speech and off-label advertisement. [Read More]