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The best and worst developments in public health have always come from moments of crisis. But many of the elixir victims were very young children, and agency officials wasted no time spinning the incident up into a national crisis. The public grew skeptical of the effort when the vaccines were linked to an extremely rare but serious side effect. “It was supposed to be this great triumph,” says Joshua Sharfstein, a professor at the Johns Hopkins Bloomberg School of Public Health and author of “The Public Health Crisis Survival Guide.” “But it ended up seeding a generation of vaccine hesitancy instead.” The takeaway from these and similar parables is clear, Dr. Sharfstein says: Crisis can be a powerful catalyst for shaping policy and improving society. The United States is in what can only be described as an epoch of crisis.
Persons: Sulfanilamide, , Joshua Sharfstein, Sharfstein, , it’s Organizations: and Drug Administration, Centers for Disease Control, Fort, Johns Hopkins Bloomberg School of Public Health Locations: Fort Dix, United States, Republic
If the Supreme Court agrees with the appeals court, the approval of mifepristone could be reset to where it stood before 2016, limiting telehealth access to medication abortion and reimplementing other restrictions. “Nevertheless, drug developers invest in new medicines because, if their investments succeed, FDA’s rigorous drug approvals and subsequent regulatory actions are sturdy enough to facilitate reliable returns. “And without necessary investment, drug development would freeze, stifling innovation and limiting treatment options for patients.”Of course, if the Supreme Court upholds the appeals court decision, the most immediate impact would be to mifepristone itself. “It is both my hope and my ‘bet’ that the court doesn’t uphold the 5th Circuit on the standing argument,” Cohen wrote. “But I have learned the Supreme Court is hard to predict much of the time.”
Persons: thalidomide, mifepristone that’s, , Daniel Grossman, ” Grossman, ” PhRMA, Glenn Cohen, Dr, Sanjay Gupta, Cohen, ” Cohen Organizations: CNN, Food and Drug, Federal Food, FDA, US, University of California San, Reproductive, Guttmacher Institute, Circuit, Appeals, Pharmaceutical Research, Manufacturers of America, Harvard Law School, CNN Health Locations: Massengill, University of California San Francisco, Texas
Historically, regulation often happens gradually as a technology improves or an industry grows, as with cars and television. In 1937, an untested and poisonous liquid version of sulfanilamide, meant to treat bacterial infections, killed more than 100 people across 15 states. “Before we seek to regulate, we have to understand why we are regulating,” said Representative Jay Obernolte, a California Republican who has a master’s degree in A.I. “Only when you understand that purpose can you craft a regulatory framework that achieves that purpose.”Brain drainEven so, lawmakers say they’re making strides. “Congress is taking the issue really seriously,” said Camille Carlton of the Center for Humane Technology, a nonprofit that regularly meets with lawmakers.
Persons: , Jonathan Lewallen, Jay Obernolte, ” Mr, Obernolte, Camille Carlton Organizations: Food and Drug Administration, University, Tampa, California Republican, Center for Humane Technology Locations: California, A.I
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