FDA Regulations Quotes

The Food and Drug Administration works to protect the interests of all patients and provide them with reliable information about the potential effects of treatments. But government rules should not stand in the way of potentially lifesaving therapies for those who do not have much time or any other options.

Consider the clinicaltrials by which drugs are tested in human subjects.5 Before a new drug can enter the market, its manufacturer must sponsor clinicaltrials to show the Food and Drug Administration that the drug is safe and effective, usually as compared with a placebo or dummy pill. The results of all the trials (there may be many) are submitted to the FDA, and if one or two trials are positive—that is, they show effectiveness without serious risk—the drug is usually approved, even if all the other trials are negative.

I have smuggled so many ingredients across so many borders, like shallot confit from Thailand, or a new sauce from New Orleans not approved by the FDA.

B17 is becoming more difficult to get because the FDA is cracking down on people dealing with B17 because, after all, doctors don't get any money off of this - it's a vitamin. And they [doctors] make a lot of money when you're sick, they don't make any money when you are well. The Bible says the love of money is the root of all evil.

When a drug comes out [that's broadly prescribed] there are going to start to be a lot of people on it [in a million person cohort] and you might get therefore an early signal of something unexpected that hadn't come through in the clinical trials. And I'm sure [drug companies] would love it if, in fact, FDA, recognizing that, would say, OK, maybe you don't have to do your trial with 30,000 people because we're going to find out shortly after registration because we'll have a lot of people taking the drug and we'll be able to see what happened using PMI.

Policies I advanced as FDA commissioner aimed to get smokers off cigarettes and onto less-harmful forms of nicotine delivery.

If a State has reliable scientific information that demonstrates that a warning is needed for a particular food, then in the interest of public health, it should share that information with the FDA and petition for a new national standard.

My struggles have been around protecting our air quality, protecting people from mercury in fish. I was very involved in the effort to get the FDA to recognize that mercury in fish is a real health issue and the FDA, you know, needed to be on that. But they were very tight with the fishing industry and did not want the public to be aware in the same way that they later didn't want the public to be aware of the problems with Vioxx, and they sat on the studies for many years and allowed 140,000 people to develop heart disease.

There is no doubt that blood must be screened in order to keep Americans safe and healthy and I am committed to working with the FDA to ensure a safe, secure blood supply, across the board. However, public policy must always be rooted in the facts, not fear.

A lot of great medicines and ancient therapies are blocked by the FDA, so that's why I choose to travel and recognize the value of diverse points of view in medicine.

I've heard drug experts say they believe if penicillin were discovered today, the FDA wouldn't license it.

The regulatory approach of the Food and Drug Administration and the Patent and Trademark Office has driven up the costs of generic drugs.