Why Trump's Latest Attack on the FDA Was Total Nonsense stat : Gizmodo
That's because in 1983, Reagan signed into law the Orphan Drug Act, creating significant financial incentives for the development of orphan drugs. Despite what O'Neill may think, there ample evidence that the drug approval process, at least, is working just fine. One of his potential nominees, however, is Silicon Valley investor Jim O'Neill, an outspoken critic of FDA regulations. Approvals for new orphan drugs have more than doubled over the past decade, with a record 37 of them approved in 2015. In January, he told a group of pharmaceutical company executives that he planned to slash more than 75 percent of drug regulations.
Rare disease drugs, like the one Megan Crowley takes or Exondys, cost upward of $300,000 per patient per year. For emphasis: the entire universe of drugs that other regulators approved and FDA didn't represents one approved drug in ten. The FDA already seems to be willing to make a bet on rare disease drugs that have less data behind them, in part because of pressure from Congress. Risks sometimes emerge with rare disease drugs, too. Acomplia, from Sanofi, was supposed to be a treatment for obesity and heart disease risk, but it increased the risk of suicidal behavior.
President Trump's address to Congress prodded biotech stocks to rocket Wednesday on his apparent support for drug innovation and a speedier FDA approval process. RELATED:Roche CEO Shrugs Off Trump's Drug Status; 2016 Sales Narrowly MissCelgene, Lilly, Merck Sit With Trump On His Calls To Manufacture In U.S.J&J CEO 'Underwhelmed' Investors After Trump Dodges Drug Pricing In September, the FDA pushed its target approval date back three months to April after requesting additional efficacy data. Trump held up Crowley, who took the helm at Amicus in 2005, as an example of innovation in the drug world. RBC analyst Michael Yee says Trump's comments support his positive thesis on the biotech sector.
collected by :Lucy William
Rare disease drugs, like the one Megan Crowley takes or Exondys, cost upward of $300,000 per patient per year. For emphasis: the entire universe of drugs that other regulators approved and FDA didn't represents one approved drug in ten. The FDA already seems to be willing to make a bet on rare disease drugs that have less data behind them, in part because of pressure from Congress. Risks sometimes emerge with rare disease drugs, too. Acomplia, from Sanofi, was supposed to be a treatment for obesity and heart disease risk, but it increased the risk of suicidal behavior.
President Trump's address to Congress prodded biotech stocks to rocket Wednesday on his apparent support for drug innovation and a speedier FDA approval process. RELATED:Roche CEO Shrugs Off Trump's Drug Status; 2016 Sales Narrowly MissCelgene, Lilly, Merck Sit With Trump On His Calls To Manufacture In U.S.J&J CEO 'Underwhelmed' Investors After Trump Dodges Drug Pricing In September, the FDA pushed its target approval date back three months to April after requesting additional efficacy data. Trump held up Crowley, who took the helm at Amicus in 2005, as an example of innovation in the drug world. RBC analyst Michael Yee says Trump's comments support his positive thesis on the biotech sector.
collected by :Lucy William
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