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FDA reprimands US doctor trying to commercialise MRT

14 August 2017

By Georgia Everett

Appeared in BioNews 913

The Food and Drug Administration (FDA) has warned a US fertility doctor to stop marketing mitochondrial replacement therapy (MRT) – a technique involving the creation of an embryo with DNA from three people.

Dr John Zhang, chief executive of New Hope Fertility Clinic and research company Darwin Life, made news last October when the world's first MRT baby was born in Mexico (see BioNews 871). Since then, Dr Zhang has been marketing MRT as a 'cure for mitochondrial disease' which can also '[prolong] natural fertility' and is a 'successful solution to age-related infertility' (see BioNews 905).

MRT was developed specifically to prevent transmission of mitochondrial disease, where the mother's eggs contain mitochondria with harmful mutations which can cause devastating disease in her children. The nuclear DNA from the patient's egg or embryo is removed, and transferred it to a donor egg or embryo with healthy mitochondria and its own nuclear material removed.

The procedure is currently not approved under US law, and Congress has banned its consideration by prohibiting funds for clinical investigations involving a 'human embryo being intentionally created or modified to include a heritable genetic modification.'

Dr Zhang had previously informed the FDA, following the success of the MRT therapy, that his centre would not 'use its spindle transfer technology again within the United States to support ex-US studies or procedures' until a suitable legal framework was in place.

However, the FDA has written a letter to Dr Zhang expressing its concerns over his company's continued marketing and promotion of the technique.

Mary Malarkey, the director for the Office of Compliance and Biologics Quality at the FDA's Centre for Biologics Evaluation and Research, explains in the letter to Dr Zhang how he had not met federal regulations when creating the embryo, and how by continuing to market the technology, he is compromising his commitment to stopping the use of MRT until approved.

The letter explores the multiple violations Dr Zhang and his team conducted in his 2016 work, including a lack of written notification to the FDA concerning export of the embryo to Mexico and manipulation of cells more than the minimal permitted allowance. While the use of MRT was not forbidden in Mexico, the treatment was still conducted unlawfully as the embryo did not meet US export licence exemptions. Malarkey continues that the 'letter is not intended to be an all-inclusive list of violations' and Dr Zhang must take full responsibility to 'ensure full compliance with the FD&C Act and the PHS Act and their implementing regulations'.

The FDA has requested Dr Zhang to notify it of the steps his centre has taken and will take to 'address [its] violation …and to prevent recurrence'.

'Darwin Life takes FDA's letter seriously', the company told the New York Daily News. 'We are fully committed to complying with all applicable requirements.'

SOURCES & REFERENCES
STAT | 05 August 2017
 
Washington Post | 08 August 2017
 
US Food and Drug Administration | 04 August 2017
 
CNN | 07 August 2017
 

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

29 August 2017 - by Dr César Palacios-González 
Almost a year after the first live birth of a baby following a mitochondrial replacement technique procedure, the US Food and Drug Administration has sent a very strongly-worded letter to the scientist and team responsible for the event...

19 June 2017 - by Shaoni Bhattacharya 
The fertility doctor who led the team which produced the world's first baby through mitochondrial replacement therapy is now looking to use the same technique in a commercial venture...
24 April 2017 - by Dr César Palacios-González 
It is not every day that we can examine the details of the first use of a new reproductive technology. But the first live birth of a baby following the use of a mitochondrial replacement technique (MRT) in IVF last year gives a window into just this. The case – with procedures carried out in both the US and Mexico – also raises legal questions...
03 April 2017 - by Helen Robertson 
Details of the world's first successful use of mitochondrial replacement therapy in IVF have been published...
23 January 2017 - by Antony Blackburn-Starza 
A baby has been born in the Ukraine following the use of an experimental IVF procedure known as mitochondrial donation...
03 October 2016 - by Dr Julia Hill 
In a world first, the birth of a baby boy who was conceived using mitochondrial donation has been reported...

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