Drug Approval Quotes

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.

Over time, yes, countries will need to look at specific GMO products like they look at drugs today, where they don't approve them all. They look hard at the safety and the testing. And they make sure that the benefits far outweigh any of the downsides.

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.

I keep encouraging the pharmaceutical companies to put more money into R&D.

Efforts to approach zero risk through exhaustive pre-release testing are extremely expensive and time-consuming. New drugs are delayed in reaching those who need them, and marginal drugs may not be developed at all.

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.

Regulators at the Food and Drug Administration have a tough job.

Over the years, HIV/AIDS activists and their allies have been pioneers in creating new frontiers in the medical establishment. Through their efforts, the FDA drug approval procedures were reformed so promising new therapies could reach desperate patients quicker.

The higher cost of getting a generic drug approved by regulators means that many old medicines don't face competitors. It's only after substantial price hikes that these drugs offer enough revenue to offset the rising generic entry costs, and start to entice competition.

The problem we are trying to solve is that of drugs that would have never seen the light of day for reasons that have nothing to do with the inherent properties of drug candidates themselves and more to do with bureaucratic institutions within which they often sit.

People moan about drugs being tested on animals. I sort of think it depends innit. If the drug's aspirin and the monkey's got a headache, is it right?

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.

Patients who face long odds and terminal illnesses do not always have access to the latest drugs in clinical trials. They don't want to give up, but they don't have years to wait for new drugs to receive FDA approval.

Would-be drug companies must either produce medicines that stand up to federal scrutiny, demonstrate that their data has value to other companies, or go out of business.

We all want our drugs to be safe - and so an essential part of the pathway to the development of a new drug is approval by a regulator.

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.

The people who work at FDA are just trying to do their jobs.

It is so very sad to see that political arguments can totally obscure the science of a drug. It's hard to see how to proceed if the release of such a vital drug [RU 486] can, and will be, held hostage to a minority of the American public.

The public properly relies upon FDA classification of drugs as nonprescription as a reflection of the agency's judgment regarding the safety and proper use of a drug without a doctor's prescription.

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.

When you prescribe a new drug, often you are prescribing something that has only been tested in a few thousand people for a very short period of time, perhaps only six months, and that's not long enough to know whether there are any medium- or long-term side effects.

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

My idea of what was going on in politics was driven by activism. I came out when I was 17, and right away I started working in the AIDS activist movement. For me, politics was about getting drugs approved and getting prisoners access to the same kind of drugs that you could get on the outside. It was about getting needle exchanges approved. That was politics. These were policy problems that were killing people, and we were trying to get them changed.

When the FDA forces an old drug off the market, patients have very little say in the matter. Patients have even less of a say when the FDA chooses not to approve a new drug. Instead, we are supposed to rely on the FDA's judgment and be grateful. But can the FDA really make a choice that is appropriate for everyone? Of course not.