Should America loosen FDA regulations to gain Competitiveness

Unlike other industries, products of pharmaceutical industries relate directly to human health because medicines mean to cure. In America, the procedures from studies to clinical research and from clinical research to market are long and costly following FDA regulations. In China and other Asian countries, there are lighter regulations regarding this matter. Naturally, drug companies seeking way to cut costs will head to Asia for their medicine inventing operations.

As a governmental oversight organization, FDA concerns about public safety to protect people from rare and difficult-to-detect risks. Its strict rules, however, make America become a place where new and safe medicines are invented and tested if looking from consumers’ perspectives.

To many drug companies in the industry, tighter regulations mean they need to spend more money for study and clinical research. In order for them to remain competitive and profitable, they outsource some of their operations stateside. Dennis Gillings was among the first to realize that studies, clinical research operations and sales should be moved overseas to Asian countries. Companies can take advantage of lower costs for human testing procedures; even though, people might question about whether or not human lives at one place is more valuable than other places.

One option is to build Asia as a center for drug studies and clinical research while applying the FDA regulations at these establishments. Drug companies could maintain their competitiveness and endure less spending for clinical research. Besides, this option will speed up the drug-marketing process and reap more revenues directly from these Asian countries. However, U.S. companies could lose their focus away from the current North America market, which is also the world’s biggest drug market. Because the life standard is different, newly invented drugs might not be sold at the prices that are sold in the U.S. Administrative costs might be an issue when marketing these new drugs back to North American.

Another option is to lobby the FDA to change their regulations and to be more flexible on common-known drugs. Companies can keep jobs within America, make benefits from the inside and outside of the U.S., and reduce the production time for new drugs. Some might argue that this can endanger public safety because common-known drugs are also common-used drugs. If these drugs turn out to be bad, its consequences will affect the majority of population. Besides, FDA is an oversight organization, there is less likely that they will change the rule simply to help companies to gain competitiveness or to be more profitable.

It is reasonable to invent new drugs at a faster speed, but it does not necessarily mean to disregard public safety concerns. Nevertheless, to remain competitive is also viable for business including pharmaceutical companies. The best choice for drug companies to achieve both purposes is to have FDA regulation to be more flexible. They might apply strict rules upon clinical research for certain medicines and be more reasonable for the common-known drugs. Outsourcing some study activities and sales will also gains competitiveness in emerging markets.


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