Last week President Trump delivered his State of the Union Address and referenced his call for lower drug costs for consumers. While the details for how drug costs could be brought down, just having the issue mentioned in the speech is a signal that President Trump has not given up on his campaign pledge to address drug costs.
In 2017, Congress approved the reauthorization of the Biosimilar User Fee Act – and five biosimilars entered the market. To date, nine biosimilars have been approved for the U.S.
As the president was preparing to deliver his speech, John Maraganore, CEO of Alynlam Pharmaceuticals and Chair of BIO, the Biotechnology Innovation Organization, wrote a column expressing his wishes for the president’s address.
In short, Maraganore called for:
- Support a productive, consistent, and transparent FDA.
- Continue to select strong leaders for HHS.
- Keep discussions on drug pricing grounded in facts. (Noting that the FDA approved 1,027 generic drugs and 56 novel drugs and biologics in 2017 — record highs and that the FDA has taken numerous regulatory actions to facilitate the entry of generic versions of complex drugs, such as biosimilars.)
- Support targeted reforms that benefit patients.
- Acknowledge that innovation is part of solving the opioid crisis.
Read Maraganore’s oped from Stat News.