Drug Approval Process 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.

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.

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

I agree, the world would be a better place if doctors were less enthusiastic about adopting very new drugs.

And thirdly, the FDA occasionally does some genuine public good with whatever energies it has left over after serving the vested political and commercial interest of its first two activities.

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.

While I am prepared to look at all options and to think 'outside the box' for effective treatments, I rightly resisted efforts to provide an unproven drug on demand to the American public.

The regulation of medicine has been a State function.

Rushing blindly towards unproven drugs can be disastrous and result in countless more deaths.

We should look for ways to expedite generic drug approvals, particularly for products that have a long history of being safe and effective.

I think FDA's concerns are patient-safety.

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

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.