How many innovative, potentially lifesaving drugs never make it to the marketplace because of the added costs in time and money imposed by the [Kefauver-Harris] Amendments? No one knows for sure, but the studies that have been done imply that we’ve lost about 80% of the innovations that we would have had in the absence of he Amendments.

Hammond shook his head sadly. “Yet, you’ll remember,” he said, “the original genetic engineering companies, like Genentech and Cetus, were all started to make pharmaceuticals. New drugs for mankind. Noble, noble purpose. Unfortunately, drugs face all kinds of barriers. FDA testing alone takes five to eight years — if you’re lucky. Even worse, there are forces at work in the marketplace. Suppose you make a miracle drug for cancer or heart disease — as Genentech did. Suppose you now want to charge a thousand dollars or two thousand dollars a dose. You might imagine that is your privilege. After all, you invented the drug, you paid to develop and test it; you should be able to charge whatever you wish. But do you really think that the government will let you do that? No, Henry, they will not. Sick people aren’t going to pay a thousand dollars a dose for needed medication — they won’t be grateful, they’ll be outraged. Blue Cross isn’t going to pay it. They’ll scream highway robbery. So something will happen. Your patent application will be denied. Your permits will be delayed. Something will force you to see reason — and to sell your drug at a lower cost. From a business standpoint, that makes helping mankind a very risky business. Personally, I would never help mankind.

A new drug takes some 10 to 20 years and around US$1 billion to US$2 billion to develop.

Even when the FDA agrees to expanded access, pharmaceutical companies are often reluctant to give terminal patients a drug that is still in development. If patients die from organ failure related to their disease, the FDA may require additional studies from the manufacturer to make sure that the death was not hurried along by the drug. Naturally, the extra studies increase the development timeline and overall cost.

Congress enacted the 1962 Kefauver-Harris Amendments to the 1938 Food and Drug Act… What the Amendments actually did was increase the time it takes for a new drug to move from the lab bench to the marketplace: a change from 4 years to 14 years over the next few decades. Terminally ill patients who couldn’t live with the delay turned to the black market to get access to potential cures. Every year, the cost of satisfying the FDA have soared, resulting to ever-increasing prices at the pharmacy. More than half of our potential innovations have never made it to patients because companies realized they couldn’t recoup their investments under the new regulations.

The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives

It takes about twelve years for a pharmaceutical firm to research, develop, test, and launch a product. Several firms, including Pfizer, Novartis, and Celgene, are working with IBM Watson to try to identify and bring new drugs to market faster.

If @balajis ran the FDA, it would literally add years to the average American's life.

The research and development of new vaccines is an expensive and risky process. They require heavy investment of time and resources, with no guarantee of success.

Every time a new drug comes out, I read what the side effects are and how many people really get better, and I add in the side effects and the adverse reactions. When you do that, and subtract out the placebo effect, not many new medications make a difference.

Journalist: There's always a fear that government involvement can slow innovation. You don't think it's too early for policymakers and regulators to get involved?

Drugs. If they did not exist our governors would have invented them in order to prohibit them and so make much of the population vulnerable to arrest, imprisonment, seizure of property, and so on.

We have parts of our system which are overwhelmed by regulation. It wasn't the absence of regulation that was the problem. It was despite the presence of regulation you got huge risks built up.

Pharmaceutical companies are better at inventing diseases that match existing drugs, rather than inventing drugs to match existing diseases.