US Industry Fears Blocking Bill Would Weaken Exclusivity
Executive SummaryUS industry fears draft legislation would weaken the 180-day exclusivity incentive to challenge patents; but it is more positive about planned reforms to rebate frameworks.
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Reforms to the US 180-day exclusivity incentive included in the Blocking Act that is part of the Lower Health Care Costs Act could cost the US healthcare system approximately $1.7bn, the AAM has warned.
Access to medicines in the US is “in jeopardy”, the country’s Association for Accessible Medicines (AAM) has warned in its latest report, despite generic drugs enabling the US to realise savings of US$265.1 billion in 2017, according to Iqvia data.
Ending the “gaming of regulatory and patent processes by drug makers to unfairly protect monopolies”, advancing biosimilars and generics to encourage greater competition and offering free generics to low-income seniors are among the measures set out in a “blueprint to lower drug prices” that has just been announced by US President Donald Trump. Billing the reform as “the most sweeping action in history to lower the price of prescription drugs for the American people”, Trump said his administration would be “eliminating the middlemen” and targeting ‘freeloading’ other countries.