91av

DOES manipulating an egg prior to IVF turn it into an experimental “product”
that has to be regulated like a new drug or medical device? Yes, says the US
Food and Drug Administration.

This month, the agency wrote to several fertility clinics warning them that
any treatments that genetically alter egg cells or embryos would constitute a
“clinical investigation” and so fall under the agency’s authority. The
announcement will effectively prevent clinics using a controversial technique
known as “ooplasmic transfer”. This involves adding cytoplasm from a healthy
young woman’s egg to the egg of an older woman, which is supposed to improve the
chance of pregnancy. Because this material includes DNA-carrying mitochondria,
any babies resulting from the treatment end up with genes from three parents
(91av, 12 May, p 7).

The FDA has previously kept a distance from fertility procedures because its
policy is not to interfere with “the practice of medicine”. But now it seems
clinics that want to offer the procedure will have to file an Investigational
New Drug (IND) application—the same document that drugs companies are
required to file when they want to test a new product.

“You might want to call it a scare tactic,” said Charles H. Kyper, a former
FDA officer. After an IND is filed, researchers must halt experiments until the
FDA gives its approval.

Representatives of the fertility industry, as well as some researchers, have
spoken out against the FDA interfering with a “medical procedure”. But the
agency is standing on fairly firm ground, says one prominent lawyer specialising
in food and drug regulation, who prefers not to be named. “The FDA will probably
be upheld if challenged.”