In the last push of President Donald Trump to bring pharmaceutical manufacturing to the United States, a new decrerably task the FDA by reducing regulatory obstacles for national producers while making life more difficult for foreign manufacturers.
The new decree, signed on Monday, asks the FDA to “reduce the time necessary to approve national pharmaceutical manufacturing factories”.
In the meantime, the order orders the FDA to “increase the costs and inspections of foreign manufacturing factories”.
The order lacks specific details or objectives, and it is not quite clear if the mandate applies to each FDA inspection or only new installations, production lines or products. Federal agencies are responsible for the design of specific rules following the orientation of a decree.
To benefit national manufacturers, Trump asks the FDA to eliminate “duplicate and useless requirements”, to rationalize exams and to “provide early support before putting online installations”.
The new commissioner of the FDA, Marty Makary, MD, appears on board the prescription and is ready to act on it.
“We had this crazy system in the United States where manufacturers of American pharmaceutical products in the United States are falling into inspections, and foreign sites are easily unleashed with the planned visits, while we have surprise visits to the United States,” said Makary when we said at the signing of the executive decree in the White House.
Instead, Makary said that the FDA “would” pass “visits to inspections in drug establishments abroad.
However, the question remains whether the agency has enough resources to carry out these foreign inspections. The FDA has a hard time with a major inspection backwards, especially in foreign countries, from the pandemic. An analysis of the Associated Press last year revealed that 160 pharmaceutical factories in India and 185 factories in China were to be inspected.
Meanwhile, the recent mass license to the FDA assigned the agency’s inspections and investigation office. Even if the inspectors themselves have been spared, the loss of administrative staff raised concerns concerning new delays and disruption of inspections.
Makary suggested that the FDA would reduce the duration of future inspections.
“Nor are we going that our inspectors drag for three to four weeks,” said Makary. “So we are going to enter and go out, and we will do more inspections with the same resources.”
In addition to the FDA, the Environmental Protection Agency was sentenced to accelerating the construction of facilities for the manufacture of prescription drugs, active pharmaceutical ingredients and other necessary raw materials.
With the support of the White House, a single point of contact between federal agencies will coordinate permit requests for national pharmaceutical manufacturing facilities “to ensure an effective and coordinated process”, according to the order.
The construction of new manufacturing capacities for pharmaceutical products and critical inputs can take up to five to 10 years, “which is unacceptable from the point of view of national security”, indicates the order.
“We do not want to buy our pharmaceutical products from other countries because if we are in a war, we are in a problem, we want to be able to do ours,” Trump said in a statement on Monday.
The decree is added to Trump’s planned prices on pharmaceutical products in its overall strategy for the production of terraced drugs. During the White House event, Trump told journalists that he will announce pharmaceutical rates in the next two weeks.
The Trump administration recently launched what is known as an investigation into article 232 to examine the implications of national security of pharmaceutical imports. The probe results could pave the way at potential prices.
Stressing Trump’s remarks during a rally of April 30, Jefferies analysts noted that the pharmaceutical prices could be implemented gradually, a mechanism that the pharmaceutical industry has sought.
“We are going to receive huge amounts of drugs and pharmaceutical companies pouring into the country (…) and we will give them time to do so. After that, there will be a price wall,” said Trump, as quoted by Jefferies.
“But they will be happy with this if they are starting to build right now,” said Trump. “And after a while, it will become more difficult, harder, harder.”
