快猫短视频

DOES manipulating an egg prior to IVF turn it into an experimental 鈥減roduct鈥�
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
鈥渃linical investigation鈥� and so fall under the agency鈥檚 authority. The
announcement will effectively prevent clinics using a controversial technique
known as 鈥渙oplasmic transfer鈥�. This involves adding cytoplasm from a healthy
young woman鈥檚 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
(快猫短视频, 12 May, p 7).

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

鈥淵ou might want to call it a scare tactic,鈥� 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 鈥渕edical procedure鈥�. 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. 鈥淭he FDA will probably
be upheld if challenged.鈥�