More than 70 drugs approved from 2001 through 2010 ran into safety concerns later that resulted in withdrawals from the market, “black box” warnings or other actions.
Even as drug pricing issues continue to draw scrutiny, federal safety regulations and incentives offer drug companies a new avenue to get a sweet return on their development costs.
Casi todos los estadounidenses con marcapasos -y personas en todo el mundo- caminan portando partes fabricadas en Tijuana, México, en donde se ha creado una industria que podría estar en riesgo si la administración Trump cambia el juego del comercio global.
The medical supply industry makes a particularly revelatory case study of the difficulties of untangling global trade.
Sen. Bernie Sanders’ bill to allow Americans to buy cheaper medicines from Canada would bypass a requirement that blocked past legislative efforts over two decades.
Marathon, maker of an expensive treatment for Duchenne muscular dystrophy, sells the drug for $140 million in cash and stock to PTC Therapeutics.
The numbers show that President Trump’s choice for FDA commissioner, Scott Gottlieb, has long-standing ties to pharmaceutical companies as a board member or consultant and that he had to recuse himself multiple times while working at the FDA.
More than 30 states have laws on the books to allow dying patients the right-to-try experimental treatments. But these treatments may not be covered by insurance, and ethicists worry vulnerable people could be exploited near the end of their lives. The laws may also duplicate a process the FDA already has in place.
Citing a Kaiser Health News investigation, Senate Judiciary Committee Chairman Chuck Grassley vows to examine the orphan drug program and possible fixes.
Tom Price will have significant authority to rewrite the rules for the Affordable Care Act.