Mar 20, 2020 08:33 PM
https://www.statnews.com/2020/03/19/with...r-it-cant/
EXCERPT: For about 20 minutes on Thursday, President Trump undermined six decades of dogma on the development of safe and effective drugs. Trump, addressing a nation under shelter and quarantine from the coronavirus pandemic, said a new drug for Covid-19, yet to be proved safe and effective, was now “approved or very close to approved.” Another, also not approved for coronavirus, would be “available almost immediately,” in part because using it is “not going to kill anybody.”
Then, minutes later, the commissioner of the Food and Drug Administration, Stephen Hahn, took the dais in the White House briefing room and delicately walked back each one of Trump’s statements. Nothing about the FDA’s deliberate process had changed, and no miracle medicine was a pen stroke away from solving the crisis. Pharma stocks that had surged fell back again.
The president’s remarks ran afoul of nearly every established FDA norm ... for instance, and avoiding promises, let alone those that can’t be kept. But they were also a sign of his long-running impatience with the realities of drug development [...] “Trump entered the White House fuming at bureaucrats ... in particular trying to bring down the FDA,” said Arthur Caplan ... “That’s pure ideology, and it turns out that ideology is barren and impotent in the face of a pandemic.”
In many ways Trump’s science policy has been defined by his disdain for red tape at the FDA. [...] The coronavirus pandemic has rekindled Trump’s eagerness to expedite the development of new medicines. But in this case the process of developing new therapies is already moving at an unprecedented pace. ... “The FDA has been a global leader in medical product development,” said Jeff Allen, president and CEO of Friends of Cancer Research. “There’s nothing to suggest that they are standing in the way of the important development and access to these therapies.”
Still, the bracing pace may not be enough for Trump. [...] Most FDA watchers can recite by heart the history of how the agency was granted the ability to review drugs for safety and efficacy in the first place. It wasn’t until a so-called “elixir” that was being promoted to cure sore throats killed over 100 people that Congress acted in 1938 to give the FDA the ability to regulate drugs for safety. Decades later, in the 1960s, a drug promoted to help with morning sickness led to thousands of babies born with lifelong birth defects. The crisis prompted Congress to again boost the FDA’s power. Among those changes were some requiring the FDA to not just consider safety, but also efficacy, when approving drugs.
Those are responsibilities that the FDA still holds dear. “Let me make one thing clear: FDA’s responsibility to the American people is to ensure that products are safe and effective. And we are continuing to do that,” Hahn said Thursday. (MORE - details)
EDIT: Videos added
EXCERPT: For about 20 minutes on Thursday, President Trump undermined six decades of dogma on the development of safe and effective drugs. Trump, addressing a nation under shelter and quarantine from the coronavirus pandemic, said a new drug for Covid-19, yet to be proved safe and effective, was now “approved or very close to approved.” Another, also not approved for coronavirus, would be “available almost immediately,” in part because using it is “not going to kill anybody.”
Then, minutes later, the commissioner of the Food and Drug Administration, Stephen Hahn, took the dais in the White House briefing room and delicately walked back each one of Trump’s statements. Nothing about the FDA’s deliberate process had changed, and no miracle medicine was a pen stroke away from solving the crisis. Pharma stocks that had surged fell back again.
The president’s remarks ran afoul of nearly every established FDA norm ... for instance, and avoiding promises, let alone those that can’t be kept. But they were also a sign of his long-running impatience with the realities of drug development [...] “Trump entered the White House fuming at bureaucrats ... in particular trying to bring down the FDA,” said Arthur Caplan ... “That’s pure ideology, and it turns out that ideology is barren and impotent in the face of a pandemic.”
In many ways Trump’s science policy has been defined by his disdain for red tape at the FDA. [...] The coronavirus pandemic has rekindled Trump’s eagerness to expedite the development of new medicines. But in this case the process of developing new therapies is already moving at an unprecedented pace. ... “The FDA has been a global leader in medical product development,” said Jeff Allen, president and CEO of Friends of Cancer Research. “There’s nothing to suggest that they are standing in the way of the important development and access to these therapies.”
Still, the bracing pace may not be enough for Trump. [...] Most FDA watchers can recite by heart the history of how the agency was granted the ability to review drugs for safety and efficacy in the first place. It wasn’t until a so-called “elixir” that was being promoted to cure sore throats killed over 100 people that Congress acted in 1938 to give the FDA the ability to regulate drugs for safety. Decades later, in the 1960s, a drug promoted to help with morning sickness led to thousands of babies born with lifelong birth defects. The crisis prompted Congress to again boost the FDA’s power. Among those changes were some requiring the FDA to not just consider safety, but also efficacy, when approving drugs.
Those are responsibilities that the FDA still holds dear. “Let me make one thing clear: FDA’s responsibility to the American people is to ensure that products are safe and effective. And we are continuing to do that,” Hahn said Thursday. (MORE - details)
EDIT: Videos added