Henry Kerali ponders whether President Trump’s anticipated FDA shakeup could result in drugs being brought to market faster than ever before
“Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products” – Donald J. Trump
Over the last few months, President Trump has given little away in terms of his vision for the pharma and biotech industries. However, drip by drip, Trump has provided small granules of what he has in store for the healthcare space.
In one of his first press conferences as president, Trump gave his clearest indication yet of what he intends to do:
We have to get our drug industry coming back. Our drug industry has been disastrous. They’re leaving left and right. They supply our drugs but they don’t make them here, to a large extent. And the other thing we have to do is create new bidding procedures for the drug industry, because they’re getting away with murder.
Pharma has a lot of lobbies, a lot of lobbyists, a lot of power. And there’s very little bidding on drugs. We’re the largest buyer of drugs in the world, and yet we don’t bid properly. We’re going to start bidding. We’re going to save billions of dollars over a period of time.
His comments above are in keeping with his protectionist vision for the US – putting America first, making America great again. To Trump, the industry has exploited tax laws in M&As whereby pharma companies have manufactured drugs overseas at a discount while selling them back home at a high price.
But if we go to the start of this article, a key part of Trump’s health care platform is the pledge to reform the Food and Drug Administration (FDA). On close inspection, one has to wonder what actually constitutes ‘reform’ in Trump’s view. While at the best of times the newly elected president is unpredictable, it’s a brave person who dares to presume what Trump is thinking at any given time.
Nevertheless, one look at the shortlist of people in line to lead the FDA offers a glimpse into the president’s thoughts.
On the one hand, there’s Jim O’Neill, the firebrand libertarian who believes new drugs should demonstrate safety before efficacy. And then there’s the outspoken doctor, Joseph Gulfo, who shortly before entering the fray to lead the FDA, made noteworthy remarks on how the administration needed sweeping reforms.
But it’s the desire ‘to put greater focus on the need of patients for new and innovative medical products,’ that hints at a future push to bring new drugs to market quicker than ever before. Cutting through the proverbial red tape, so to speak. While that would have its advantages – faster timelines, cheaper clinical trials, etc. – regulations would need to be eased.
That, industry experts agree, would have a knock-on effect that would involve lowering standards already in place. Bringing drugs to market quicker could potentially put the patient’s safety at risk and therein lies the problem. The patient’s safety is paramount.Therefore, depending on who Trump nominates to lead the FDA, the commissioner will need to balance the act of fulfilling the president’s aim to bring drugs to market quicker, while ensuring the patient is safe and out of harm’s way.
PHOTO CREDIT: Gage Skidmore via Flickr Creative Commons