The commissioner of the Food and Drug Administration, Dr. Scott Gottlieb has recently vowed to bring the new science to market it faster and in hopes that patients to have benefited from the treatment.
Medications have already cleared the regulatory hurdles which is said to be much faster, and it is not clear that people who were opposed to drug companies. Since last few years, FDA has been lowering the standards by which it decides about the new medications that are safe and useful. The agency now requiring the fewer and smaller clinical trials and it approves some drugs after one successful trial. It also accepts short-term effects and instead of that it clear clinical outcomes and ever and even some small improvements in health as sufficient proof that medication usually works and is worth selling.
The shift now seems to be practical, and the nature of pharmaceuticals has already changed. The drugmakers are now pursuing the personalized therapies which work instead of developing the broad-spectrum medicines which usually work for masses. This need to test in small populations and in that conditions, it shares the same genetic profiles, and it can make the large clinical trials which are said to be waste.
When we are not careful about the changes, it will underway and will do more harm. It is said that red tape is bad when lives are at stake, and the regulations are created, and the history is about what happens when we don’t have them.
As per the industry watchdogs, reducing the clinical trial costs will not be helping to curb the list prices as investment costs, and they do not determine those prices are determined by what the makers think about the market can bear, and it will help them in setting their profit margins. When the standards are low, then they inhibit innovation by giving the companies less incentive to make the substantial improvements in their offerings.