A great article about the fact, that regulation in the FDA drug approval field does more harm than good. If anyone has time, please read this article, it's worth reading. We all know, that there are few to none drug approvals in certain fields but lets suppose we have a new blood pressure drug. Lets suppose, that this new drug only works in patients with a certain gene. The FDA requires a phase III trial with 1000 patients. 90% of the participants do not have this gene and the drug doesn't work for them but the other 10% receive an optimal drop in blood pressure and have no side effects. The FDA doesn't take genetics into account and many times we have no clue, what genes are responsible for what outcome. So in this case, the FDA would refuse approval, although this drug works perfectly in 100% of the people with the special gene. Following this logic, the FDA will refuse any personalized medicine because effectiveness for 1000 randomly chosen study participants cannot be proven, because the drug is tailored only for some. Here are some excerpts. http://www.bloomberg.com/news/2013-02-28/fda-reform-can-lift-u-s-economy.html Both Democrats and Republicans know that excessive regulation is slowing innovation in the industry. Shortly before the 2012 election, the President’s Council of Advisors on Science and Technology released a report, which received bipartisan praise, asserting “broad agreement that our current clinical trials system is inefficient.” One inefficiency the report identifies is outdated regulation. The inability of the Food and Drug Administration to keep pace with changes in medical science threatens both economic prosperity and public health. The drug-approval process is glacial: It takes about 12 years and $1.2 billion to develop a single new drug that is approved by the FDA. The council’s report establishes an ambitious, yet reachable, national goal: doubling the current annual output of new medicines for patients. We believe existing evidence suggests this goal can be met by altering the FDA’s onerous clinical-trial requirements. ... These Phase 3 clinical trials served us well in the past. Today, in an era of precision or personalized-drug development, when medicines increasingly work for very specific patient groups, the system may be causing more harm than good for several reasons. First, because of their restrictive design and the way the FDA interprets their results, Phase 3 trials often fail to recognize the unique benefits that medicines can offer to smaller groups of patients than those required in trials. Second, information technologies have created improvements in our ability to monitor and improve product performance and safety after medicines are approved for sale. Post-market surveillance can and should reduce dependence on pre-market drug screening in Phase 3 trials. Third, reducing reliance on Phase 3 trials is unlikely to introduce an offsetting harm induced by more dangerous drugs, since evidence supporting safety is produced in earlier phases. Manufacturers also have powerful incentives to maintain drug safety, since they take enormous financial hits -- well beyond the loss of sales -- when drugs are withdrawn after approval. ... Based on data from the widely cited Tufts Center for the Study of Drug Development, doing away with Phase 3 trials would reduce development costs by 25 percent. A study by the economist Daron Acemoglu of the Massachusetts Institute of Technology and other research suggest that a 1 percent increase in innovative returns would raise the number of new products introduced by at least 4 percent. Boosting returns to 60 percent, then, implies a 240 percent gain in new products. Even if we assume a much more conservative effect -- say, less than half of that -- the increase in new products would be 100 percent, doubling medical innovation. ... Existing evidence, gathered across diverse drug classes that treat HIV, cancer and cardiovascular disease, suggests that the gain to patients beyond the sales of treatments (what economists call “consumer surplus”) ranges from five to nine times the sales. That is, patients gain more in health and longevity than they pay for their treatments. Thus, the value to patients from doubling an industry that is 2 percent of gross domestic product would range from 10 percent to 18 percent of GDP.