Is there a certain length of time that the FDA requires to test something?

Question

I'm writing a novel. In this novel, a new chemical is made to replace nicotine. Here is the information as of the current writing:

When the chemical was introduced to the FDA, it was tested over the time period of eight months. Since, at the time, addictive materials in cigarettes were not regulated heavily enough to prevent the use of this new chemical, it was put into mass production immediately after its approval. The short-term effects were similar to nicotine’s. Aside from addiction level, the two were the same. However in the long run, the chemical would begin to invade our blood cells, our bones, nerves, and even our brains.

Assuming this is an apocalyptic science-fiction novel: is most of the information accurate? Does eight months seem reasonable, or does the FDA have a certain period of time that all new materials must endure?

Answer 1

It's not so much that they say, 'you must test it for X amount of time'. It's that it takes a crapload of time to come up with the safety and efficacy data that they require to consider approval. For most substances, they're identified in the lab, and it takes about eight years to get them from animal tests, to completing a Phase III trial that they can send to the FDA for an approval letter. Some drugs take longer. The time for cancer drugs is quoted at 14 years. The duration of trials depends on what you're trying to treat. Trials of for necrotizing fasciitis might last a month. Diabetic or cancer trials could last years.

However, what you're describing seems almost to meet the category of 'food additive' rather than drug. The approval process for a food additive is substantially different.

Here is the data you need to approve a food additive:

http://extoxnet.orst.edu/faqs/additive/a...

http://extoxnet.orst.edu/faqs/additive/t...

As you can see, you can come up with pretty good toxicity data in 8-12 months. However replacing something like nicotine would be subject to enormous scrutiny. The idea is not too farfetched though. There's an idea floating around to replace alcohol with a substance called Pagoclone - which has the same good effects as alcohol, but not the toxic problems. (http://jop.sagepub.com/cgi/content/citat...

I can't give you further access to this article, it's protected journal content, but you can purchase it yourself if you're interested, or if you're affiliated with a university, most pay for subscriptions for all staff/students.

Answer 2

New chemical entities (NCEs) intended for use medicinally have a lot of hurdles to overcome before they get approved.  The clinical testing phase prior to approval involved phase I studies that are there to demonstrated safety and don't last very long ( < 4 weeks); phase II studies which are to determine safety and efficacy.  These will be in more patients and over a longer period of time, and often will involve separate dose-finding clinical trials, and a separate TQT study to determine that the drug does not have any detrimental effect on the heart (in particular prolonging the QT interval-TQT stands for thorough QT).

Once this is complete the candidate will need to under go 2 pivotal phase III trials with a lot more patients (to reduce any potential statistical errors).  This process will take many years (estimate 8 years to complete phase I - phase II, bt acute treatments would require shorter clinical trials than chronic therapiesI) as it is an enormous effort to set up a trial and get the necessary regulatory approval.  In conjunction with the clinical studies you need to conduct nonclinical toxicology studies the studies that would need to be completed  are 9 month repeat dose studies, reproductive studies (~ 1 year to complete) and carcinogenicity studies (2 years).  

If the compound is not intended for medicinl usage and is a NCE, the clinical phase will be shorter (not sure what clincial studies would be required), but I suspect that the same nonclinical studies would be necessary, especially carcinogenicity studies (from the sound of it the chemical would be administerd chronically (smokers smoke all the time) so 2 year carc studies would most likely be needed.

In a novel however, I'm sure nobody would mind a little bit of bending of the truth, in the introduction/conclusion you cn always mention that the real regulatory procedures are more indepth than described.