The first in a series of articles to help you deal with legislative and regulatory issues as President Trump and a new congress take hold. To view the series, visit Buchanan's 100 Days in a Minute.
Hope in the Midst of Uncertainty
The New Year ushered a period of uncertainty for the pharmaceutical industry. We face the beginning of the Trump Administration and a Congress with both houses controlled by Republicans focused on repealing Obamacare. The financial cost of this repeal could be significant to the healthcare industry. This change, combined with President Trump’s economic nationalism and attacks on drug pricing, create an atmosphere of doubt and uncertainty for the pharmaceutical industry. Additional complicating factors include the expiration of the Prescription Drug User Fee Act and the Generic Drug User Fee Act in September of this year. The fees generated by these pieces of legislation contribute to the majority of the revenue supporting the drug approval process. Legislative replacements will need to be enacted to ensure the status quo or improvement to the current rate of NDA and ANDA approvals. For the past 25 years, Congress sought to pass clean User Fee bills. That has never happened and is unlikely to happen this year.