STEPHEN MOORE: FDA Can Save Lives By Keeping Copycat Drugs Away From Market

For decades, the United States has led the world in pharmaceutical innovation – developing drugs that combat cancer, heart disease, AIDS, diabetes, and other killer diseases.  One recent study found that “in health-sciences output as measured by the Nature Magazine Index, the United States’ share is many multiples higher than the next 10 leading countries combined.”

A major reason for U.S. dominance in drug development is our world class research conducted by the American bio-engineering facilities and the tens of billions spent each year searching for cures. The industry’s research and development has saved and improved tens of millions of lives in the U.S. alone and perhaps ten times that number around the world. Yet, somehow Washington has come to regard the industry as a villain.

The newest U.S.-produced wonder drug – Zepbound – is extraordinarily effective in driving major weight loss.Along with Ozempic and Wegovy, which are manufactured by the Danish company Novo Nordisk, it is now being used by millions of people – about 70% of Americans are overweight – and contributing to an improvement in the country’s health. Users of the drug treatments, which suppress appetite, typically lose 10%-20% of their body fat after taking the shots. This miracle drug is reducing lives lost from obesity, heart disease, cancer  and stress – while allowing millions of Americans to become more active and feel better about themselves.

Many other breakthrough drugs created by U.S. companies are helping people live longer and healthier lives. But the cost of developing new drugs and getting them approved typically exceeds $2 billion – and takes 10-15 years – according to the Tufts Center for the Study of Drug Development. There’s also a high failure rate – 90% of drugs that reach the clinical trial phase never come to market.

Given these high costs and slow approval times, pharmaceutical companies, researchers and those who invest billions of dollars of private capital in this research need to be confident that they will be rewarded when they succeed in getting a drug approved. For every drug approved by the FDA, there are a dozen or more that fail and lose money for investors. The rare wonder drug “hits” have to pay off to cover the cost of the much more common dead-end research – the “misses.”