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House Appropriators Include Historic Rider to Restrict Gene Editing Review at FDA

June 7, 2019

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PRESS CONTACTS
Christa Wagner, Senior Legislative Analyst

The House Appropriations Committee June 4 agreed by voice vote to an amendment to the FY 2020 Agriculture, Rural Development, and Food and Drug Administration (FDA) spending bill to reinstate restrictions on FDA’s ability to review applications for clinical trials involving human gene editing.

The provision offered by Rep. Robert Aderholt (R-Ala.) states that FDA may not use funds towards “submissions for an investigational use of a drug or biological product … in research in which a human embryo is intentionally created or modified to include a heritable genetic modification.” The committee passed the spending bill, including this amendment, by a vote of 29-21.

This language has been included in the FDA spending bill since FY 2016 and was excluded in the Subcommittee’s FY 2020 draft spending bill. Subcommittee Chair Sanford Bishop (D-Ga.) noted during full committee markup that the omission was intended to engage a discussion of the emerging technology, which has not occurred in the time that the provision has been included in the spending bill.

Full Committee Chairwoman Nita Lowey (D-N.Y.) added that the debate should be held under the purview of the authorizing committee and not appropriators. Though she voted for the amendment, Lowey added that the United Kingdom does allow certain, regulated uses of human gene editing, including for mitochondrial replacement therapy.

Additional debate on the ethics of gene editing arose with Rep. Jeff Fortenberry (R-Neb.), who cautioned against “maverick bioengineers” who could conduct unethical research with developing technology. Rep. Debbie Wasserman Schultz (D-Fla.) countered with her experiences as a survivor of hereditary breast cancer, noting she would support research that could help prevent inheritance of her mutation. She added, “There are real opportunities … to try to cut off the passing on of genetic mutations that can have dramatic life-altering implications.”

The Agriculture-FDA spending bill will not be included in a five bill “minibus” package that the House of Representatives will consider on the House Floor with an expected start date of June 12. According to a committee press release, the minibus will include the Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) spending bill as well as the Legislative Branch, Defense, State-Foreign Operations, and Energy and Water Development bills. The Appropriations Committee passed the FY 2020 Labor-HHS bill May 8 [see Washington Highlights, May 10].

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