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FTC Challenges Patent Listings to Promote Competition and Lower Drug Prices
The U.S. Food and Drug Administration granted its initial approval for Ozempic in 2017, marking a significant milestone in the pharmaceutical industry. Recently, the U.S. Federal Trade Commission (FTC) made an announcement that reverberated throughout the sector. The FTC disclosed its intention to dispute over 300 patent listings associated with 20 different brand name drugs as part of a broader strategy to enhance competition and drive down exorbitant drug prices. Among the drugs targeted by this initiative is Novo Nordisk’s renowned diabetes treatment, Ozempic.
Listing Disputes and Regulatory Impact
The patent listings called into question are meticulously documented in the Food and Drug Administration’s (FDA) Orange Book, a comprehensive registry of FDA-approved drugs that encompasses details regarding drug ingredients, manufacturing processes, and intellectual property. The FTC asserts that inaccuracies or fraudulent listings contribute to the inflation of drug prices, resulting in financial burden for consumers.
“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” stated FTC Chair Lina M. Khan.
The FTC, driven by a commitment to combat illegal practices that hinder market accessibility, promptly notified the FDA about the contentious listings and issued cautionary correspondence to 10 pharmaceutical entities, including Novo Nordisk. In its correspondence to Novo Nordisk, the Commission raised objections concerning patent listings tied to the company’s Ozempic, Saxenda, and Victoza products. Novo Nordisk responded by indicating that they are currently evaluating the FTC’s letter.
Under the FTC’s regulatory framework, drug manufacturers have a 30-day window to either retract or revise the disputed listings, or provide compelling evidence of their compliance with regulatory directives. This stringent approach underscores the regulatory authority’s unwavering commitment to ensuring transparency and fairness in the pharmaceutical landscape.
Past Challenges and Ongoing Scrutiny
Notably, this recent development follows a similar action taken by the FTC in the previous fall, when more than 100 patent listings were contested, prompting several companies to voluntarily delist certain patents. The intensifying scrutiny on Novo Nordisk emerges shortly after U.S. Senator Bernie Sanders launched an investigation into the pricing practices associated with Novo Nordisk’s Wegovy and Ozempic in the U.S. market.
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