Since 1985, the first President of the United States affect the FDA's regulatory functions. The new executive orders to bypass Congress, Obama recently, the use of administrative means to promote economic and employment, as part of improving people's livelihood. President Obama has signed an executive order to address the increasingly serious drug shortage in the United States, especially some of the treatment of cancer and resistance to bacterial infections. The executive order instructed FDA to take three measures: first, requiring pharmaceutical companies to stop production of a prescription drug in advance of filing, so that hospitals and other manufacturers have sufficient time to adjust; Second, speed up the site for new plants the new suppliers of pharmaceutical plant extracts administrative approval rate, shorten time to market; Third, the Ministry of Justice, to examine whether drugs shortages lead to price extortion or illegal hoarding.
This is since 1985, for the first time a U.S. president affect the FDA's regulatory functions. The executive orders to bypass Congress, Obama's recent use of administrative means to promote economic and employment, as part of improving people's livelihood. Obama administration aims to do so to show the determination of government to solve national problems, even if the bill in Congress face the risk of rejection. Earlier this year so far, the U.S. government announced that there are at least 180 kinds for the treatment of childhood leukemia, breast cancer, colon cancer, infections and other diseases of the critical shortage of drugs. Part of the shortage of medicines in the market price spikes 80 times. Because some clinical studies of new drugs as control drugs fail to provide the old drug, resulting in some of the test was delayed.
Executive Order issued by President moderate intensity. Analysts believe that although some help, but not quickly or completely solve the problem, but should be seen as a long-lasting and complex campaign. In fact, Obama avoided the more ambitious proposals, such as the establishment of government drug storage or production plan, which lies in the shortage of drugs directly to the government, although the effect will be immediate, but no doubt push up government costs.
Nevertheless, Obama issued an executive order is sufficient to reflect the American people to improve the quality of life for his beliefs. In contrast, Republican lawmakers and other presidential candidates almost unanimously that the solution to the current national economic difficulties and other problems depends largely on the government to reduce regulatory intervention in the market to develop more,
Irinotecan and let the market more freedom to operate effectively. The United States without a government regulatory agencies like the FDA, as a more comprehensive and complete to the heart of people's lives, consumers have for every dollar spent 25 cents by FDA regulation.
In 2010, 74% of the shortage of drugs for the treatment of cancer or pre-operative anesthetic sterile injection. As the pharmaceutical market, financial and technical barriers exist to make small pharmaceutical companies to participate in market competition. At present, only five major hospitals to buy 90% of the required medicines at the same time, only seven companies to produce the required majority of drugs. In most cases, a company can produce at least 90% of the market needs of the drug and some important bulk drugs. But in fact it is difficult to find drugs in the United States self-produced raw materials. At present most of the major bulk drugs from China and India. Despite steady growth in demand in recent years, but supply capacity remained unchanged, thus deepening the supply tension.
Such a large demand depends only on the supply of a few companies and factories, once the drug safety problems could have an enormous destructive power. Studies have shown that nearly half of the shortage of drugs in the subsequent inspection found serious quality problems,
glutathione including the injection of glass fragments, metal shavings, or bacterial contamination. Even if the generic drug industry is also called, should be more regulated pharmaceutical market. Generic drug industry recently agreed to an annual $ 300 million to the FDA to step up inspections and speed drug approval.
In the U.S., if the generic drug companies have 1% of its revenue from the country, there is 5% of the profits generated, the Government has confidence in the solution to the current plight of drug shortages. Therefore, generic manufacturers will actively build more capacity in the United States, and ultimately solve the plight of drug shortages. In the meantime, the Obama administration will strengthen the FDA shortage of medicines management team to deal with events related to drug supply,
pharmaceutical raw materials while making communication with the suppliers of these drugs work. The government will also issue a letter to pharmaceutical manufacturers to remind them of the drug supply interruption to bear legal responsibility, to inform them about situations that could lead to drug interruption. Government officials said the shortage of drugs to expand the production capacity takes time to agree, but Obama's executive order to speed up the process. Obama will be the House and Senate legislative request for this executive order to put pressure on pharmaceutical manufacturers. FDA submitted to the Justice Department documents show that Obama's executive order to crack down on small pharmaceutical wholesalers in the gray market price gouging or collusion behavior. Source:http://www.cospcn.com