Medical network - on February 8, the President of the United States and trump in medical circle grabbed headlines.
▍ 80% FDA regulations is waste
In recent days with the U.S. drug r&d and production organization (PhRMA), Merck, Novartis, Johnson & Johnson and its CEO at, President of the United States pledged to trump to optimize drug approval process.
But at the same time, trump said on the FDA's rules, guidelines, regulations, etc., will no longer be a 9000 - page now, and should be 100 pages, about 75% to 80% of the FDA regulation will be cut. As others have noted, no matter where drug production, these pharmaceutical companies must comply with the laws and regulations, in order to enter the American market, because this is the world's largest pharmaceuticals market.
This is not the first time he mentioned on the FDA's reform, but as much as 80% of the current laws and regulations were cut, still shocked the world, after all, the American FDA regulation as reference and template, will be how to face the following drug regulatory policy evolution, seems to have become an urgent thing in an instant.
▍ global r&d "back"
In fact, the trump to show the attitude of the new drug research and development has been concern to the global market.
"A lot of drug companies like to develop a new drug is close to dying patients, and the FDA would say, you cannot use this drug, the patient will die...... we don't know whether the drug will be effective, but these patients survived 4 weeks at most." He said.
He further argues that, on the one hand, drug firms in dying patients for clinical trials, aims to arouse the FDA heart of compassion, to expand the passing rate of examination and approval of drugs; As the FDA to all kinds of green channel, on the other hand, these drugs approved in advance, and experts said the drug trial in dying patients, some patients have completed the whole treatment, some patients has yet to start. In many cases (99%) indications for the expansion of application, the FDA has not yet formally approved the use of experimental drugs, the company already let patients in clinical trials.
Heard the news, the global market.
"We do not sell coke or Sprite, people can consider they tasted the drinks like it or not." CEO of Massachusetts, a biotechnology company executives said, "but our product is saving life drugs!"
Many pharmaceutical industry executives also said that the great changes in the FDA seems beneficial to a business, but it doesn't have to be, because this change will lead to enterprise is difficult to distinguish their good product and fake and inferior products, after all, if the company declared a drug "cure-all", and people eat the invalid, also seems to be no problem.
Previously, trump has said publicly that other countries must pay more for the development of medical cost. Enterprises need to go back to the United States, and exports of drug prices need to be higher, and announced that "we must stop the rest of the world to enjoy free circulation of the American medical development", and called for the pharmaceutical industry to go back to the United States. |
