The US Food and Drug Administration (FDA) recently proposed new plans to include the altering of animal DNA as if it were a pharmaceutical. But what does this mean?
The draft put forward by the FDA wants to see them regulate the altering of DNA. The Food, Drug and Cosmetic Act states that a drug is defined as something that intentionally alters a body’s structure or function, which is exactly what gene altering does. Although DNA isn’t specifically classed as a drug, it can have the same outcome, which is why they want to place regulations on the process to ensure that it is kept safe.
At present, the FDA does not get a say in the gene altering of animals which has created loopholes in how companies use genetics. With no regulation, the FDA feels that any DNA altering could have a detrimental effect. After all, there is no guarantee that adding or subtracting elements from an animal’s DNA will always go to plan.
Whilst still in the draft stage, the FDA is asking for public input to prove that gene altering is low risk. This gives genetics companies the chance to demonstrate their understanding of health and safety to the FDA. They must highlight the safety of animals whose DNA is being altered, of those consuming the animals and the effect that it will have on the environment.
Some people are not happy with the new proposals, namely genetics companies who have been working on the very same thing the FDA is trying to regulate. Some argue that work already in progress will be lost or delayed due to the planned regulations. There will be a mass of extra work that will need to take place, meaning more staff and additional paperwork, including proposals through http://www.fdathirdpartyreview.com/ for the FDA 510k clearance submission. This could arguably be a massive drawback for those progressing in making various cures. Others argue that there is no need for regulations when the gene altering that is taking place is simply speeding up what would naturally happen.
The FDA draft is something that has divided those involved. However, the proposal will not be finalised until April and has passed giving the public chance to weigh in on this highly controversial plan.