The Trump administration issued rules in 2020 that allowed states to apply to import drugs. Florida is Apply first The company would later sue the FDA in 2022 for “reckless delay” in approving the application.
The agency has now authorized the state's Section 804 Import Program (SIP) (see Section 804 of the Federal Food, Drug, and Cosmetic Act). 2 years.
Under this program, Florida can import Certain prescription drugs from Canada If doing so can reduce costs for Americans without jeopardizing public health and safety.
Americans have long been allowed to buy prescriptions as individuals from Canada, but this is the first time a state has allowed the same.
Efforts to import cheaper medicines from overseas have been proposed for years, but have never materialized. hampered by safety concerns.
The FDA will address those concerns in Florida's plan, which will require quarterly reporting to the state's health department on potential safety and quality issues.
including other states Vermont, Colorado and maine Some companies have applied for SIP authorization, but others have encountered obstacles along the way.
“After years of obstruction by federal bureaucrats, Florida will now be able to import low-cost, lifesaving prescription drugs,” Florida Gov. Ron DeSantis (R) said Friday. “It's time for the FDA to put patients over politics and the interests of Floridians over Big Pharma.”
The types of medicines expected to be imported include therapeutic drugs. Asthma, COPD, diabetes, HIV/AIDS and mental illness.
The US pharmaceutical industry is probably legal battle We oppose this cost-cutting measure.
The Pharmaceutical Research and Manufacturers Association (PhRMA), an industry group that previously sued over the Trump administration's import plan, said it was “considering all options” to prevent the policy from taking effect.
“We are deeply concerned about the FDA's reckless decision to approve Florida's import plan,” said Stephen J. Uble, PhRMA Chairman and CEO. “Ensuring patients have access to the medicines they need is important, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious risk to public health. Politicians need to stop getting between the American people and health care.”
