Update (9/18/2018): Last week, as the U.S. House of Representatives was reconciling its spending bill for the Health and Human Services Department (HHS) with the amendment package passed by the U.S. Senate that is discussed below, House Republicans declined to adopt S.Amdt. 3964, which would have provided HHS with $1 million to issue rules requiring pharmaceutical companies to list prices
After the tragic February 14 shooting at Marjory Stoneman Douglas High School in Parkland, Florida, students across the country have taken to the streets.
The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills seeking to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to clarify how drug and device manufacturers can legally discuss uses of
The U.S. Food and Drug Administration (FDA) and Amarin Pharma, Inc. (Amarin) have released a stipulation and settlement order that would resolve all causes of action raised in Amarin’s successful lawsuit against the agency, with both parties waiving the right to appeal. On August 7, 2015, the U.S. District Court for the Southern District of
Pacira has announced that it settled its lawsuit against FDA over the labeling and promotion of its postsurgical analgesic drug, EXPAREL®. FDA approved EXPAREL (bupivacaine liposome injectable suspension), in October 2011 for “administration into the surgical site to produce postsurgical analgesia” based on two clinical trials involving pain after bunionectomies and hemorrhoidectomies. Although the drug’s
Lately, there seems to be a palpable uptick in news related to FDA’s regulation of off-label communications. Here are some of the developments we’ve been following: In April: CDER Director Janet Woodcock noted in her remarks at the FDLI Annual Conference that the agency is “currently evaluating our advertising policies in light of first amendment
Does a university have the right to stop an artist from selling paintings and other expressive items that depict the school’s football uniforms? In a recent case involving the University of Alabama, the Eleventh Circuit Court of Appeals’ answer was no. The court held that a painter’s First Amendment right of expression outweighed the university’s
On March 19, the Supreme Court announced, without comment, that it would not hear an appeal from two religious student groups challenging San Diego State University’s decision not to grant official recognition to the groups. In Alpha Delta Chi-Delta Chapter v. Reed, the student groups had argued that the university violated their First Amendment rights