The development and approval process for drugs customarily takes 15 or more years and costs an average of $1.2 billion. In today’s environment, venture capital firms, whose funding is the fuel for the innovative biotech and drug development industry, see little prospect of a return on investment and impossibly long timelines. Efforts to bring drugs to market are seen as thwarted by an FDA shackled by rigid guidelines outdated and irrelevant to today’s medical breakthroughs.
Most important innovations come from small venture backed biotech firms and not Big Pharma, who minimize development risk with marginal drugs already classified by the FDA. On occasion Big Pharma buys an innovative breakthrough drug company product, while the rest of the small biotech firms have to fend for themselves, usually unsuccessfully. With venture funding walking away from the US medical products industry, there is no way to bring the vast majority of medical breakthroughs to American patients. The time, risk and cost is just too high, and the funding sources are simply leaving.
There is a common misconception that streamlining or shortening the process or changing access points threaten patient safety. This is simply not true. Much of the delay has nothing to do with science or safety. The statistics and methods the FDA uses are outdated, generally not relevant to prove safety, and in terminal disease are typically unethical and unsafe to patients. In fact, far more people have died due to unnecessary approval delays and placebo’s than have died from early access to safety tested drugs.
The unfortunate reality today is that not only have we lost many tools in the war on cancer and other deadly diseases due to an archaic and inappropriate regulatory system, the rate of loss is increasing. Innovative companies are increasingly going abroad, leaving American’s last in line for the most advanced treatments. Medical travel agencies are now cropping up to help send Americans abroad. American doctors will no longer be the leaders in providing top treatment and care – their foreign contemporaries will be. This is not a someday problem but a now problem. Americans need to prepare for travel to Europe, India, China, Australia, Israel or Brazil to beat deadly diseases – if they can afford it.
Copyright Fight to Live 2019