Trump Takes Aim at Speeding Approvals
President Trump took aim at speeding up FDA’s approval process during his 2/28 address to Congress. Noting that it was Rare Disease day, Trump illustrated the need for getting therapies to patients sooner by profiling rare disease survivor Megan Crowley, who was sitting in the Capitol gallery.
“Megan was diagnosed with Pompe Disease, a rare and serious illness, when she was 15 months old,” Trump said in his address. “She was not expected to live past five. On receiving this news, Megan’s dad, John, fought with everything he had to save the life of his precious child. He founded a company to look for a cure, and helped develop the drug that saved Megan’s life. Today she is 20 years old and a sophomore at Notre Dame.”
“Megan’s story,” Trump continued, “is about the unbounded power of a father’s love for a daughter. But our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need. If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles like Megan. In fact, our children will grow up in a Nation of miracles.”
But cutting regulations at FDA may do more harm than good, many experts argue (see earlier story). FDA is already the fastest regulatory agency in the world getting drugs approved. And many delays that occur in drug development are related to delays in conducting clinical trials needed to demonstrate safety and efficacy, or in assuring that a manufacturing facility can make quality drugs.
Pharmaceutical scientist Derek Lowe told Vox.com that he has spent 28 years in the lab and has seen hundreds of thousands of compounds tested on a huge variety of drug targets, but he has never brought a drug to market. The reason? “We don’t know how to find drugs that work,” he said. For every 5,000 compounds discovered in the preclinical phase of drug development, only about five show enough promise to be studied in humans. The real hurdle researchers face is not so much regulation, it is struggling with human biology in the lab, according to Lowe.
Consumer advocacy group Public Citizen is less diplomatic in its reaction to president Trump’s claims that FDA’s approval process is “slow and burdensome. ” The group says that his claims “reflect complete ignorance about the FDA’s current regulatory schemes for ensuring that medications and medical devices are safe and effective... The regulatory pendulum for the FDA’s review of medical products already has swung too far toward promoting speed over the rigor of evidence demonstrating safety and effectiveness. Trump’s reckless proposal to slash FDA regulations in an effort to further speed FDA’s review of medical products would dangerously undermine FDA’s approval processes and lead to countless preventable injuries, deaths and illnesses across the U.S.”