Written by Owen Healy, ’20* (PDF Version)
I. Introduction
Consider the following hypothetical: A researcher at a private lab sends a sample of RNA to physicians at a hospital. The physicians combine the RNA with a protein to create a gene-editing molecule. The RNA will match a sequence of DNA on Chromosome 4, and the protein will delete a gene for Huntington’s disease. The physicians hope this procedure will provide treatment to their patient.[1] The next day, the lab receives a visit from an FDA investigator. The RNA sample is a drug, the investigator says, and distributing it to hospitals without FDA approval was a violation of federal law.[2] The lab disagrees: The researchers view a pattern of RNA bases as a message telling the physicians where in the DNA to cut. They could have sent the pattern by writing it on paper, but using RNA was convenient because the molecule would bind to the corresponding DNA sequence without circuitous translations. Moreover, the lab insists the message was nothing more than a true statement about the human genome: “Next to this pattern lies the gene for Huntington’s disease.” How can the FDA prohibit the lab from sharing knowledge about its discoveries? The lab claims it is engaging in “functional speech”—that is, speech designed to convey information to a tangible object, like a machine, with no human intermediary.[3] The disagreement between the agency and the lab is whether such a message is speech at all. While the lab focuses on the informational content of the molecule, the agency focuses on its functional capacity.[4] To the agency, the sample is no different than any other chemical designed to alter the human body.
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