President Trump’s first couple of weeks have people taking him literally, not just seriously. What does that mean when it comes to the regulation of drugs?
As I wrote in early December (Would an FDA radical make any real difference), I’m not convinced that even a major shift away from regulation will dramatically change the market. Even if the bar for approvals is lowered, third-party payers will still want to see compelling safety and efficacy data before they provide reimbursement. Medicare and Medicaid may also up their game by directly or indirectly discouraging prescribing of medications that are unproven.
The pendulum tends to swing back and forth between the demand for speedy approval and concern about harms to patients from inadequately tested drugs. Recently the pendulum has been swinging toward fast approval, and the newly enacted 21st Century Cures Act continues that trend.
But what will happen when a drug that’s rushed to market causes patient injury and death?
“We’re going to be cutting regulations at a level that nobody’s ever seen before. … And we’re going to have tremendous protection for the people — maybe more protection for the people,” Trump said Tuesday.
Trump is promising the impossible, and it may come back to bite him. Then again, maybe it won’t.February 1, 2017