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Focus on Regulation

Tag Archives: First Amendment

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

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

It’s Settled … At Least Somewhat: Settlement of the First Amendment Case Amarin Pharma v. FDA

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

FDA Settles Pacira’s First Amendment Lawsuit

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

Recent First Amendment Rumblings

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

Eleventh Circuit Sides With Artist In Dispute Over the Depiction of the University of Alabama’s Uniforms

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

Supreme Court Declines to Review Appeal by Christian Student Groups

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