\u3ci\u3eUnited States v. Caronia\u3c/i\u3e: Off-Label Drug Promotion and First Amendment Balancing

Off-label drug promotion is commonplace in the United States, but it is not without its dangers. While the Food, Drug, and Cosmetic Act does not explicitly ban off-label promotion, the Food & Drug Administration (FDA)— in order to protect consumers from unsafe and ineffective drugs—has taken steps to regulate it. The FDA does so through its intended-use regulation, which lists the types of evidence the FDA can consider in determining whether a drug is misbranded. It is a crime to sell a misbranded drug into interstate commerce or to conspire to do so. On September 25, 2015, the FDA proposed an amendment to the regulation, which has drawn opposition from various industry groups due to its potential to restrict the type of speech that is often used in off-label promotion. The First Amendment challenge to the proposed amendment rests on United States v. Caronia, in which the FDA was prevented from using truthful, nonmisleading speech to convict a pharmaceutical representative of a conspiracy to sell a misbranded drug. This Note examines whether the amendment to the regulation is permissible under Caronia. It first contends that the regulation does not facially violate the First Amendment. It further argues that the rule is constitutional and does not pose the same First Amendment issue as was seen in Caronia as long as the FDA implements it with care. This Note concludes by exploring various ways that the FDA can constitutionally regulate off-label drug promotion under the proposed rule

Positive solutions to indefinite Neumann problems when the weight has positive average

We deal with positive solutions for the Neumann boundary value problem associated with the scalar second order ODE $$u" + q(t)g(u) = 0, \quad t \in [0, T],$$ where $g: [0, +\infty[\, \to \mathbb{R}$ is positive on $\,]0, +\infty[\,$ and $q(t)$ is an indefinite weight. Complementary to previous investigations in the case $\int_0^T q(t) < 0$, we provide existence results for a suitable class of weights having (small) positive mean, when $g'(x) < 0$ at infinity. Our proof relies on a shooting argument for a suitable equivalent planar system of the type $$x' = y, \qquad y' = h(x)y^2 + q(t),$$ with $h(x)$ a continuous function defined on the whole real line.Comment: 17 pages, 3 figure

Keck Observatory Laser Guide Star Adaptive Optics Discovery and Characterization of a Satellite to the Large Kuiper Belt Object 2003 EL_(61)

The newly commissioned laser guide star adaptive optics system at Keck Observatory has been used to discover and characterize the orbit of a satellite to the bright Kuiper Belt object 2003 EL_(61). Observations over a 6 month period show that the satellite has a semimajor axis of 49,500 ± 400 km, an orbital period of 49.12 ± 0.03 days, and an eccentricity of 0.050 ± 0.003. The inferred mass of the system is (4.2 ± 0.1) × 10^(21) kg, or ~32% of the mass of Pluto and 28.6% ± 0.7% of the mass of the Pluto-Charon system. Mutual occultations occurred in 1999 and will not occur again until 2138. The orbit is fully consistent neither with one tidally evolved from an earlier closer configuration nor with one evolved inward by dynamical friction from an earlier more distant configuration

Comment on "Local accumulation times for source, diffusion, and degradation models in two and three dimensions" [J. Chem. Phys. 138, 104121 (2013)]

In a recent paper, Gordon, Muratov, and Shvartsman studied a partial differential equation (PDE) model describing radially symmetric diffusion and degradation in two and three dimensions. They paid particular attention to the local accumulation time (LAT), also known in the literature as the mean action time, which is a spatially dependent timescale that can be used to provide an estimate of the time required for the transient solution to effectively reach steady state. They presented exact results for three-dimensional applications and gave approximate results for the two-dimensional analogue. Here we make two generalizations of Gordon, Muratov, and Shvartsman’s work: (i) we present an exact expression for the LAT in any dimension and (ii) we present an exact expression for the variance of the distribution. The variance provides useful information regarding the spread about the mean that is not captured by the LAT. We conclude by describing further extensions of the model that were not considered by Gordon,Muratov, and Shvartsman. We have found that exact expressions for the LAT can also be derived for these important extensions..