Trump Criticizes ‘Slow and Burdensome’ FDA Approval Process

In a joint session of Congress on Tuesday evening, President Donald Trump repeated his attacks on the US Food and Drug Administration’s (FDA) “slow and burdensome approval process,” promising to “slash the restraints, not just at FDA but across our government.”

The speech, widely regarded as a positive step away from his more off-the-cuff rallying cries, pointed to Megan Crowley, who was in attendance in the Capitol and is diagnosed with a rare condition known as Pompe disease. Her father’s company won FDA approval in 2006 for a treatment that could help those suffering from Pompe disease.

But the example is counterintuitive to Trump’s claims that FDA needs to further speed its approval process, particularly as the Pompe treatment won approval after nine months of FDA review. The case highlights how FDA can approve a treatment for a rare and unmet medical need in less time than for most generic drugs, and based on less data than what a drug for a non-rare disease would need for approval.

FDA currently has four different tracks companies can take to speed medicines to patients with unmet needs, including the Fast Track (expedites the review of drugs to treat serious conditions), Breakthrough Therapy (for drugs that could substantially improve on available treatments), Accelerated Approval (approval based on a surrogate endpoints) and Priority Review (six-month FDA review instead of 10 months) processes.

The comments also highlight a fundamental misunderstanding about how FDA works. As experts have explained to Focus, the agency cannot unilaterally slash its own approval standards without modifications to laws set in place by Congress. And none of the bills introduced since Trump took office further address the approval process as just before Trump took office, Congress passed the mammoth 21st Century Cures bill in early January.

At another point in the speech, Trump also pledged to “work to bring down the artificially high price of drugs and bring them down immediately,” echoing comments he has made earlier. But the comments lack specifics of how Trump and his administration, which has yet to appoint an FDA commissioner, would take aim at spiking prices.

How the approval process will become faster, less expensive and still keep Americans safe has yet to be revealed. As the chemist Derek Lowe has pointed out, “Many people (and many politicians among them) seem to imagine that there’s this big logjam of wonder drugs that’s having to work its way slowly through a thin hallway full of persnickety bureaucrats – if only we could open those floodgates! But this isn’t actually the case.”