Our position paper addresses the HHS FY19 Budget as released on Feb 19, 2018. AAM holds:
- The 180-day exclusivity provision is critical to promoting earlier entry of generic competition.
- The HHS proposal could reduce generic drug competition by undermining the main incentive for generic drug companies to challenge weak or questionable patents.
- The HHS proposal may have the perverse effect of increasing drug prices.
- The HHS proposal is unnecessary and does not address costly brand name drug prices.
- The HHS proposal appears to be based upon the faulty assumption that subsequent generics will go to market when first applicants won’t.
- The HHS proposal is a blunt instrument that could unfairly penalize generic companies that are diligently working to address deficiencies.
Issues