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.
The guidance documents noted that Zika is spread primarily by mosquitos, but it could also spread through sexual transmission between human partners. The FDA recommended that blood donors and the
families of human tissue donors defer donations if they had recently traveled
to Zika outbreak areas. Moreover, the FDA recommended that donors who had shown symptoms of Zika infection, or may have been exposed to another person with symptoms of a Zika infection, self-defer donations. The FDA recommended that regulated industries implement the guidelines as soon as possible, but no later than four weeks after publication.
The FDA’s actions represent one effort by President Obama’s administration to control and mitigate the potentially devastating effects that Zika could have on Americans.The President has also asked for $1.9 billion in aid from Congress to fund relief efforts and prepare the states for Zika outbreaks. The gridlocked House and Senate have thus far refused to fund the effort of the President. However, it appears that progress is being made and votes are expected in the coming days. Regardless, the CDC is referring to the Zika outbreak as “Scarier than we initially thought.” The question remains, as is the case lately, whether or not Congress will act in time to stop the spread of Zika virus to the continental U.S.
Michael D. Robinson, MPH, MBA,
JD, LLM, is an attorney licensed in Illinois and currently runs a small
health law practice, The Law Firm of Michael D. Robinson & Associates,
LLC, located in Chicago where the firm focuses on food and drug law, regulatory compliance, and professional licensure. He may be reached at MDRobinson@MDRobinsonLaw.com www.MDRobinsonLaw.com.