Since the likelihood is that many readers of this blog will be asked to comment when the Supreme Court, some time this week, announces its decision in Hobby Lobby and Conestoga Wood Specialty cases here’s a brief refresher and some links. The cases are challenges to the Affordable Care Act’s requirement that employers who choose to offer health insurance to their employees must provide policies that include ten essential benefits-including contraception. The U.S. Supreme Court has heard oral arguments and read the briefs—it’s likely that whatever opinion is issued will reflect at least some of the arguments presented to the Court.
This case is about the Affordable Care Act’s requirement that employers who offer their employees health insurance must include ten essential benefits, including contraception. Hobby Lobby and Conestoga Wood are privately held, for-profit companies whose owners have sincerely held religious objections to providing four specific kinds of contraception. They believe these contraceptives terminate rather than prevent pregnancy. Many religious organizations and companies have gotten exemptions to these requirements, but this case considers whether private, for-profit companies should qualify as well.
The cases raise three major issues:
Does the Religious Freedom Restoration Act apply to corporations even though it uses the word “person?” (Can companies have religious beliefs?)
Is providing insurance that covers birth control a “substantial burden?” on these two company’s’ religious beliefs?
Does the government have a compelling reason for requiring companies that provide insurance to have it cover birth control?
At Regulatory Focus earlier this week, Alexander Gaffney wrote about what he characterized as “a torrent of studies” that FDA is conducting or has proposed conducting on prescription drug promotion, and, in particular, on direct-to-consumer advertisements. The studies include, among others, a surveystudy aimed at sussing out “the influence of DTC advertising in the examination room and on the relationships between healthcare professionals and patients”, a study exploring similarities and differences in the responses of adolescents and their parents to web-based prescription drug advertising, and a study that will use eye tracking technology to collect data on the effect of distracting audio and visuals on participants’ attention to risk information.
Gaffney speculates that “the proposed studies could indicate coming changes in FDA’s regulatory approach toward advertising[.]” Another possibility is that the studies are part of an effort by FDA to build up the evidence base supporting its current regulatory approach. In a Tweet commenting on Gaffney’s article, Patricia Zettler–a Fellow at Stanford Law School’s Center for Law and the Biosciences who was formerly an Associate Chief Counsel for Drugs at FDA’s Office of Chief Counsel–asks whether the data generated by the studies could help insulate FDA from First Amendment challenges. Continue reading →