AAM Calls For A Balance Instead Of Banning Pay-For-Delay
As Biden’s Executive Order Asks FTC To Scrap Pay-For-Delay And Similar Deals
US President Joe Biden has signed an executive order asking the FTC to ban so-called “pay-for-delay” reverse-payment settlements. According to the order, this could help curb high prices that are in part the result of lack of competition among drug manufacturers. However, talking exclusively to Generics Bulletin, AAM senior vice president Jeff Francer insists on a balance, explaining that such settlements result in earlier access to biosimilars and generics.
You may also be interested in...
AAM Applauds HHS For Acknowledging Brand-Driven Cost Increases
The AAM has applauded US proposals to lower drug prices, following the development of the HHS’s 45-day plan in response to president Joe Biden’s executive order on promoting competition. However, AAM chief executive Dan Leonard has criticized Congressional proposals to weaken the 180-day incentive for first generics and curtail patent settlement agreements as “misguided.”
Patient Organizations Urge Zero Co-Pay Policy To Lower Biosimilars Cost
A group of organizations representing patients, consumers, providers and taxpayers have extended support to the zero co-pay policy which would decrease significant barriers for prescribing lower-cost biosimilars. The stakeholders have urged the US HHS and CMS to reform Medicare payment policies, “which would allow patients better access to lower cost biosimilars.”
Teva Launches First-Ever CREATES Act Suit
Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.