Today, the United States Senate passed a package of four spending bills to fund various agencies within the federal government. One of the agencies is the Food and Drug Administration (FDA) — which enforces drug, medical device, and biologic safety laws.
The bill continues to prohibit the FDA “from spending money to evaluate, research, or clinical applications in which a human embryo is intentionally created or modified, including a heritable genetic modification.”
This language was included in Congressional appropriations bills after Chinese scientists were able to successfully modify human embryos.
Federal law currently prohibits federal funds from being used for the creation of human embryos for research purposes and for research in which human embryos are destroyed; privately-funded research remains legal in the United States.
The language in the bill the Senate passed is aimed at preventing the FDA from considering drugs or therapies developed through the modification of human embryos.
Critics of the language have cited concerns about limiting potentially life-saving research. And criticisms regarding the effectiveness of the language have also been raised:
First of all, banning federal funding won’t stop efforts to edit human embryos, it’s just going to move them into private industry. “You’re not going to stop it, you’re just going to shift it into private hands and let the market regulate it,” Arthur Caplan, a bioethicist at NYU Langone Medical Center told Business Insider.
Stanford law professor Hank Greely pointed out that the spending ban only applies to clinical research on human embryos (where the embryo is a considered a “drug” given to the mother), not on basic research.
“Specifically, the new provision limits the Food and Drug Administration’s ability to acknowledge that it receives research requests to modify embryos in a clinical setting, but researchers don’t need that approval if the “drug” (i.e. the embryo) is not being given to a person, he said.
While the language in the bill may be aimed at protecting human embryos from experimentation and destruction, it does not outright prohibit either. Without a prohibition, it seems likely this kind of research will continue, as Pharmaceutical companies are investing heavily in gene editing technologies.
The Biotechnology Innovation Organization, the world’s largest trade organization representing the biotech industry, put out a policy brief stating,
“As scientific developments progress, BIO urges continued discussion on this topic with important stakeholders, including members of the patient, caregiver, regulatory, legal, academic, ethical and faith communities to determine if and and under which conditions current policy ought to be changed, leaving the door open for future debates.”
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