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On July 17, US time, FDA Administrator Scott Gottlieb publicly criticized biotech pharmaceutical companies for using unpleasant strategies to keep low-cost competitors out of the market. The Brookings Institution, the US think-tank, also said in a recent speech that it is developing a Biosimilars Action Plan that includes improving the development and approval process for low-cost biosimilars and trying to find more effective The way to make quality and cheap biosimilars benefit doctors, insurance institutions and patients.

On July 18th, FDA Administrator Scott Gottlieb issued a statement saying that the FDA is preparing a special working group to conduct a specific audit of US drug imports. It is reported that the specific policy of the restructuring of the organization includes allowing the FDA to approve the import of foreign drugs to the United States in the case of “a sudden increase in drug prices and insufficient available substitutes”. For example, when the price of generic drugs expired in the United States suddenly rises, the territory lacks. In the case of other supply channels, it is possible to approve foreign alternatives to enter the US market.


Gottlieb said in the statement: “We want to know whether short-term, foreign competing drugs can help the FDA to better work when domestic drug supply channels are limited, so as to meet the patient’s treatment needs for a period of time until new Domestic competing products enter the market.”


The new working group will then need to identify a range of issues, such as the urgency criteria for introducing imported drugs and how the FDA should ensure the safety of the introduction of competing products. The organization will also consider collaborating with the US Department of Health and Human Services to assess the need for drugs to enter the United States.


It is reported that during the biosimilars program, US President Trump conducted part of the drug price policy reform, and Trump appointed FDA director Gottlieb also launched Trump’s political vision. Gottlieb said: “Our biosimilars companies are repeating the original business strategy indefinitely, and reviewers are always in the same misunderstanding of the safety and effectiveness of biological products.”


But Gottlieb himself said that importing low-cost generic drugs also faces many challenges. In his 2016 article, he mentioned that large pharmaceutical companies have cheap generic production plants overseas, but if they are allowed to enter the US, these pharmaceutical plants may not increase production to meet market demand, because this Will destroy their original product price rating.


Another obstacle to this plan is the cost of imported drugs. In fact, Gottlieb should be the one who knows the most about this problem. Because the current US drug import regulatory policy is exactly what he himself drafted when he worked in the FDA in 2004. He once said on the “Forbes” website: “This plan adds too much cost to imported drugs, making it difficult for these imported products to gain a price advantage in the US market.”


US Secretary of Health and Human Services Alex Azar also issued a statement saying that the FDA’s decision to set up a working group was given his instructions. He said that the difference between this plan and the previous abortion plan is that the imported drugs are mainly focused on drugs that are monopolized during the non-patent period and whose domestic supply channels are monopolized, which enhances the feasibility of the plan.


Azar mentioned: “The Department of Health and Human Services will follow the president’s political blueprint for priority US patients. If the innovative program is effective, safe, and respectful of patients’ choices and accessibility, then our department is open. Attitudes include the conditional opening of new drug imports.”

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