FDA Regulation Quotes

It's time to get the FDA to reverse its 1994 decision not to label GM foods.

As was noted in the Wall Street Journal, last March 21st, FDA approval of drug labelling, '...requires seven to ten years, and costs each applicant an average of $70 million.'

The FDA is redefining birth control as abortion. The FDA is setting the bar higher for this kind of drug.

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.

There's a certain libertarian right-wing view that there should be no FDA, that people can decide for themselves whether medicines are safe and effective. That's nonsense. Most people don't have the expertise or the resources to mount a proper study to find out whether a treatment is safe or effective.

We don't have a farm-to-table food safety system. I keep saying this. It came as a big surprise to the FDA that tomatoes were being grown in the United States, sent to Mexico for packing, and then sent back. I mean, they had no idea that our food chain worked like this.

However, FDA attempted to reverse this clear congressional intent in March, 1979, by proposing to regulate vitamins and minerals as 'Over-The-Counter' drugs.

If the FDA would spend a little less time and effort on small manufacturers of vitamins...and a little more on the large manufacturers of...dangerous drugs..., the public would be better served.

The FDA has received over a million comments from citizens demanding labeling of GMOs. 90 percent of Americans agree. So, why no labeling?

When the FDA announced its intentions to join other countries and ban quinolone use on U.S. chicken farms, the drug manufacturer Bayer initiated legal action that successfully delayed the process for five years.

You can't treat an illness with cosmetic surgery, and that's why it would be great if there were qualified therapists in plastic surgeons' offices, and that people would go to a therapeutic meeting before plastic surgery. I think that should be part of the FDA requirement.

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.

If you go to the FDA with a drug that's only meant to treat 50 people, and it's a 95 percent cure rate, you'll get your drug approved.

While faulty information from a digital health tool can influence people to make bad decisions, the risks are far lower than those posed by the usual products FDA subjects to pre-market review.

When birth control pills were available in Europe but not in the United States, American women created an uproar about how the unwillingness to make the pill available showed a contempt for the lives of women. When the Food and Drug Administration (FDA) released birth control pills with high dosages of hormones that were later found to be unnecessarily high, they were attacked for not caring about women enough to do the necessary tests.

As Apple advances the medical promise of its watch and smartphones, it has also made clear that its foremost aim is to steer clear of Food and Drug Administration regulation.

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

I'm offering solutions to address rising healthcare prices by adding transparency to our drug pricing, clearing the backlog on pending drug applications at the FDA, and providing oversight and accountability within the healthcare industry.

By law and institutional culture, FDA seeks to apply a single tool to its approach to regulation - the requirement for pre-market approval. The agency is accustomed to compelling innovators to submit evidence to FDA and seek permission for marketing.