by Karl Kapp
It is clear that the new President of the United States is no fan of regulation. In fact, recently, he signed an executive order requiring that two federal regulations must be rescinded for every new federal regulation put into place. He stated that “this will be the biggest such act that our country has ever seen,” and he said “there will be regulation, there will be control, but it will be a normalized control.” And in a recent speech to congress, the President declared, “we have undertaken a historic effort to massively reduce job-crushing regulations, creating a deregulation task force inside of every government agency.”
What remains to be seen is the impact on regulating bodies such as the FDA; will the new reductions reduce the effectiveness of the FDA or spur growth opportunities as promised?
In the broader healthcare arena, we do know that the new President wants to both repeal and replace the Affordable Care Act with “reforms that expand choice, increase access, lower costs, and, at the same time, provide better healthcare” and appoint an FDA Commissioner who is interested in reducing the “red tape” involved with the drug approval process.
What this means for the medical and pharmaceutical industries remains unclear.
However, the President has indicated that he wants to “work to bring down the artificially high price of drugs, and bring them down immediately.” He also wants to overhaul the FDA and bring major changes in policy. This includes steps to accelerate the process of approving new prescription drugs. In his 100 day action plan, he said reforms will include cutting the red tape at the FDA; there are over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.
Critics are worried that the strong reputation for safety that American pharmaceutical firms have may be in jeopardy if regulations are relaxed but others are excited at the opportunity that fewer regulations may afford in terms of time to market and other measures of success.
Currently, it seems like several forces are coming together to impact the FDA in a substantial but, as of yet, unknown way. The best thing to do at this point is to take a wait and see approach and try to remain fast and flexible to be able to shift as the industry begins to change in new and unanticipated ways.