This spring, the media is full of stories about outbreaks of Zika virus throughout the world. The current outbreak began in Brazil last year, but just this week, a case of Zika infection was discovered in fetal tissue in Puerto Rico. The U.S. Centers for Disease Control and Prevention (“CDC”) confirmed the widespread outbreak of Zika to the island this past Friday. The CDC confirmed 925 total infections in Puerto Rico to date. Zika virus infections can cause severe birth defects in unborn fetuses.

In part to stop the spread of the virus, the U.S. Food and Drug Administration (“FDA”) recently published two separate guidance documents covering human blood donations at blood banks (dated February 2016) and human tissue donations at human tissue manufacturers (dated March 2016). Human tissues regulated by the FDA include skin, bone, reproductive tissues, corneas, ligaments, and others. Please note, FDA guidance documents are non-binding on the blood banking or human tissue manufacturing industries, but they are most often followed by industry as they generally reflect the FDA’s current thinking. Regulated industry generally, and wisely so, follows FDA guidance documents to demonstrate general compliance with all applicable regulations that carry the weight of law.

Read more

Robinson, Michael D., Zika Virus Outbreak Will Likely Spread to the Continental United States: Will We be Ready for It?, DePaul College of Law: Mary and Michael Jaharis Health Law Institute: E-Pulse Newsletter (Jun. 2016),