FDA SLASHES DRUG TRIAL RULES – U.S cuts red tape for biosimilar drugs in major healthcare shake-up to lower soaring costs
The US Food and Drug Administration has announced plans to slash the number of human trials needed to approve certain biosimilar drugs — in what it calls a major step to drive down America’s rising healthcare costs.
The agency’s new draft guidance aims to speed up access to cheaper alternatives of complex biotech medicine. U.S Health Secretary Robert F. Kennedy Jr. says the move is part of a wider push to make life-saving treatments more affordable.
Pharmaceutical companies including Pfizer and Merck have pushed back, warning it could damage innovation, while generic makers such as Teva and Sandoz have welcomed the reform.
Biotech drugs remain the fastest-growing and most expensive class of medicines in the United States.The announcement follows recent pricing deals between President Donald Trump and major drugmakers, signalling fresh pressure on the pharmaceutical industry.
Kennedy also addressed claims about the painkiller Tylenol, advising that it should be used with caution. His comments come as Texas sues the manufacturer Kenvue — and after Trump warned pregnant women against taking the drug.
