Pharmaceutical

FDA Program Allows Importation of Health Canada-Approved Drugs, Opening New Opportunities for Pharmaceutical Access

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Miami, Florida – The importation of drugs approved by Health Canada into the United States may become a reality under a new program established by the FDA. Recently, the FDA approved a proposal for the Section 804 Importation Program (SIP) in Florida, making it the first state to receive approval for importing pharmaceuticals approved by a foreign regulator. This groundbreaking move could pave the way for other states, like Colorado, to seek FDA approval for similar programs. While the availability of Canadian-approved drugs in the US is promising, it presents unique challenges for foreign manufacturers … Read more

Federal Judge Dismisses Pharmaceutical Industry Lawsuit Over Medicare Drug Pricing Program

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Austin, Texas – A federal judge in Austin has dismissed a lawsuit brought by pharmaceutical industry bodies challenging a new Medicare program that allows the government to negotiate prices for expensive drugs. U.S. District Judge David Ezra, appointed by Ronald Reagan, sided with the Biden administration in throwing out the lawsuit. The Pharmaceutical Research and Manufacturers of America (PhRMA) group and two others had claimed the program was unconstitutional. Under the program, known as the Inflation Reduction Act, the Department of Health and Human Services is authorized to seek lower prices for certain drugs, ultimately … Read more

Unlocking the Future: Essential Insights into the Shifting Landscape of Pharmaceutical Litigation

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Boston, MA – As the pharmaceutical industry continues to evolve, so too does the landscape of pharmaceutical litigation. With a keen eye on these trends, industry experts anticipate several key developments that will shape the future of this legal arena. First and foremost, the rise of generic drugs is expected to contribute to an increase in pharmaceutical litigation. With more generic versions of brand-name drugs entering the market, patent disputes and allegations of product liability are likely to ensue. Additionally, as generic drug manufacturers seek to capitalize on market opportunities, they may face their own … Read more

Pharmaceutical Industry Group Takes Legal Action Against Florida’s Prescription Drug Importation Program

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MIAMI, Florida – The Pharmaceutical Research and Manufacturers of America is reportedly preparing to file another lawsuit against Florida’s FDA-approved program to import prescription drugs from Canada, according to an unnamed source cited by Endpoints News. This legal action comes after the FDA recently approved Florida’s Canadian Prescription Drug Importation Program, a two-year initiative aimed at lowering drug prices for American consumers by importing certain prescription drugs from Canada. Under the program, Florida’s Agency for Health Care Administration must ensure the authenticity and compliance of the imported drugs with FDA standards. The program is being … Read more