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Brief of diving:
- Food and drug administration should look for ways to streamline regulations on new north -American medicine manufacturing facilities to accelerate their completion and promote national supply, under an executive order signed on Monday by President Donald Trump.
- The order also aims to increase the inspections of foreign manufacturing plants that supply the North -American Funded by an increase in rates “insofar as it is in accordance with the applicable law.” The FDA will reveal the annual number of abroad inspections by country and by manufacturer.
- This year, large pharmaceutical companies have announced an investment of more than $ 170 billion in new manufacturing facilities in the United States, as they seek to consolidate their supply chains and avoid possible new rates. Public comments are due on Wednesday in an investigation by the Department of Commerce on the national security risks of drug imports and ingredients, which could set the stage for new rates throughout the sector.
Divide vision:
The pharmaceutical industry is pressured by the Trump administration along three different channels: taxes, trade and drug prices. The company’s executives have accredited the tax and job reduction law, approved in 2017 during the Trump’s first administration and expires later this year, to cause national manufacturing investments, including the billions of dollars announced so far by 2025.
In the meantime, the threat of drugs and the ingredients manufactured abroad is a risk to their profit prospects, which cannot be easily resolved by increasing the prices established through negotiations with insurers. Finally, the White House is looking for ways to stop drug prices that could go beyond what was enacted in the law of inflation reduction.
Along with Monday’s executive order, Trump said that an ad about drug prices and rules could reach the next two weeks.
Johnson & Johnson’s push, Eli Lilly, Merck & Co., Novartis and Roche is a part of an effort to overcome the US drug supply chain and a part of public relations that trumps Trump to reverse the course on new rates or new drug prices.
The creation of new drug factories requires time – Executive order claims that it takes five to ten years, which means that the billions of dollars spent on new manufacturing capacity this year will have an insignificant effect on ensuring the supply chain. In order to build more quickly, the executive order asks the FDA to reduce review steps “duplicate or unnecessary requirements” and maximize “punctuality and prediction”.
In license inspections, the order indicates to the FDA that “ensure that all the necessary inspections are quick, efficient and limited to what is needed to ensure compliance”, as well as evaluate if all scheduled inspections are necessary. In the meantime, the new inspection requirements for foreign plans supplying the United States could provide another incentive to move the state of production.
And on Tuesday, the FDA announced a plan to extend the non -announced inspections of abroad manufacturing plants that supply the North -American Market, although the head of the Inspection Office, Michael Rodgers, sharply announced its withdrawal in the midst of labor cuts at the Inspection Office, according to CBS News.
Alex Schriver, Senior Vice President of Public Affairs of the Lobbying Group of Industry, Pharmaceutical Research and the Manufacturers of America said in a statement that the order was a “welcome step to support the hundreds of billions of $ -American investments”.
But he added: “Imposing the rates on medicines or the adoption of foreign price fixation policies would lead to less North -American investments and weakened North -American leadership at a time when we are facing the growing competition of China.”
Publisher Note: This story has been updated to add to the FDA’s foreign inspection plan.
