US President Donald Trump has signed an executive order that provides for reforms in the pharmaceutical industry. It is aimed at reducing the prices of prescription drugs and speeding up the registration of generics and biosimilars. The American leader's decision may eliminate one of the pharmaceutical industry's main complaints about the law since the administration of former head of state Joe Biden. According to Trump, this is how he put "Americans first again."
In particular, Trump instructed the country's Ministry of Health and Congress to revise the Inflation Reduction Act, passed under Biden, so that the US government would have the right to set the cost of individual drugs covered by the state insurance program Medicare (covers 66 million Americans, mostly aged 65 and older).
“The message is clear: The executive branch will no longer stand idly by as drug manufacturers charge patients in our country more than patients in other countries for the same prescription drugs, often made in the same place,” the order says.
According to the current law, the cost of drugs in tablets must be reduced after 7 years from the date of their registration by the US Food and Drug Administration (FDA), and for injections - after 11 years. Such time frames force manufacturers to give preference to some dosage forms to the detriment of others, which negatively affects the innovative potential of the industry.
In addition, Trump's decree includes the task of simplifying the procedure for registering generics and biosimilars, which was assigned to the FDA. The American regulator should also increase the volume of drug imports from Canada (Trump proposed this initiative during his first presidential term). To date, only Florida has received FDA permission to directly import drugs from Canada, although several other states have submitted applications.
The American leader's order also touched upon a number of other shortcomings in the country's healthcare system. Currently, hospitals in the United States receive significant discounts on drugs thanks to their purchasing power: on average, 35% lower than for Medicare. Trump's order requires eliminating this gap. In addition, it is planned to bring the cost of medical procedures to uniformity in all institutions in the country.
Representatives of Big Pharma, including MSD, Eli Lilly, and Pfizer, met with Trump in February 2025 to push for these legislative changes. The head of the industry’s largest lobbying organization, Pharmaceutical Research and Manufacturers of America (PhRMA), was also present. Drugmakers have complained about the terms of Medicare’s negotiating authority, saying it will stifle innovation. In particular, the industry objected to the time frame for negotiating most drugs.
US drug companies lobbied to revise the law on lowering drug prices after Trump returned to power, seeking to extend the period before which drug prices are not negotiable. Seven lobbyists and executives from pharmaceutical and biotech companies told the media that they sought to extend the period of maintaining fixed drug prices by four years.
The sweeping order signed by Trump comes a day after the administration launched what it calls a Section 232 investigation of the Trade Expansion Act into pharmaceutical imports, which could provide the legal basis for the tariffs Trump had previously announced .
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
In particular, Trump instructed the country's Ministry of Health and Congress to revise the Inflation Reduction Act, passed under Biden, so that the US government would have the right to set the cost of individual drugs covered by the state insurance program Medicare (covers 66 million Americans, mostly aged 65 and older).
“The message is clear: The executive branch will no longer stand idly by as drug manufacturers charge patients in our country more than patients in other countries for the same prescription drugs, often made in the same place,” the order says.
According to the current law, the cost of drugs in tablets must be reduced after 7 years from the date of their registration by the US Food and Drug Administration (FDA), and for injections - after 11 years. Such time frames force manufacturers to give preference to some dosage forms to the detriment of others, which negatively affects the innovative potential of the industry.
In addition, Trump's decree includes the task of simplifying the procedure for registering generics and biosimilars, which was assigned to the FDA. The American regulator should also increase the volume of drug imports from Canada (Trump proposed this initiative during his first presidential term). To date, only Florida has received FDA permission to directly import drugs from Canada, although several other states have submitted applications.
The American leader's order also touched upon a number of other shortcomings in the country's healthcare system. Currently, hospitals in the United States receive significant discounts on drugs thanks to their purchasing power: on average, 35% lower than for Medicare. Trump's order requires eliminating this gap. In addition, it is planned to bring the cost of medical procedures to uniformity in all institutions in the country.
Representatives of Big Pharma, including MSD, Eli Lilly, and Pfizer, met with Trump in February 2025 to push for these legislative changes. The head of the industry’s largest lobbying organization, Pharmaceutical Research and Manufacturers of America (PhRMA), was also present. Drugmakers have complained about the terms of Medicare’s negotiating authority, saying it will stifle innovation. In particular, the industry objected to the time frame for negotiating most drugs.
US drug companies lobbied to revise the law on lowering drug prices after Trump returned to power, seeking to extend the period before which drug prices are not negotiable. Seven lobbyists and executives from pharmaceutical and biotech companies told the media that they sought to extend the period of maintaining fixed drug prices by four years.
The sweeping order signed by Trump comes a day after the administration launched what it calls a Section 232 investigation of the Trade Expansion Act into pharmaceutical imports, which could provide the legal basis for the tariffs Trump had previously announced .
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
