A Quote by Scott Gottlieb
Regulators at the Food and Drug Administration have a tough job.
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If you believe one of the biggest problems confronting the country is overregulation by this administration, the single most effective way to begin to rein in the aggressive regulators, who in my view have done great damage to this economy, is in the bills that fund the regulators.
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.
The regulatory approach of the Food and Drug Administration and the Patent and Trademark Office has driven up the costs of generic drugs.
One of the most powerful weapons in the Food and Drug Administration's arsenal is its ability to censure companies that promote drugs for unapproved uses.
The vast amount of waste and sheer stupidity in government - from the Pentagon to the Food and Drug Administration - could fill committee agendas for years.
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.
In the world of medicine, a trial refers to clinical research that follows a predefined plan or protocol. A clinical trial must comply with strict health, safety and ethical regulations determined by the Food and Drug Administration.
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.
Competition leads both drug companies and private regulators to be trustworthy. If they are not trustworthy, they die.
We're charged by Congress with regulating financial institutions. We take that mission seriously. We are tough supervisors and regulators.
It is not enough to show that drug A is better than drug B on the average. One is invited to ask, 'For which people ("& why") is drug A better than drug B, and vice versa? If drug A cures 40% and drug B cures 60%, perhaps the right choice of drug for each person would result in 100% cures.'
The field of U.S. cancer care is organized around a medical monopoly that ensures a continuous flow of money to the pharmaceutical companies, medical technology firms, research institutes, and government agencies such as the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) and quasi-public organizations such as the American Cancer Society (ACS).
Once an effective drug is approved to treat a deadly condition, introducing a second drug to treat the same disease can be hard. It's tough to recruit patients with a debilitating disease for a clinical trial when a proven medicine is already available.
In the US, banking and finance are regulated on the federal and state level, there are multiple federal bank regulators, and there are separate securities and commodities regulators.
The Philippines is very important to me strategically and militarily. And I've had numerous conversations with the leader of the Philippines and - and he's got a big problem. He's got a massive drug problem. He's been very, very tough on that drug problem, but he has a massive drug problem.
Internet pharmacies return to consumers the choice promised by supporters of the 1938 Food, Drug and Cosmetic Act. That law established federal requirements for drug safety and labeling but exempted prescription medicines from the labeling rules.
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