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WASHINGTON (AP) – Congress OKs bill speeding federal drug approvals, mapping $6.3 billion for biomedical research, battling drug addiction.
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WASHINGTON (AP) – A bipartisan bill to speed government drug approvals and bolster biomedical research cleared its last procedural hurdle in the Senate on Monday in an emotional moment for outgoing Vice President Joe Biden. The overwhelming 85-13 vote put the measure on track for final legislative approval by the Senate as early as Tuesday. President Barack Obama has promised to sign the measure, one of the last for the president and the 114th Congress, whose leaders hope to adjourn by week’s end after a two-year session that has seen them clash frequently with the president. The bill envisions providing…… [read more]
President Donald Trump pledged Tuesday to expedite drug approvals and force foreign nations to pay their fair share for drugs manufactured in the U.S. “We’re gonna be changing a lot of the rules. We’re going to be ending global free loading,” Trump said during a White House meeting with pharmaceutical industry executives. “Foreign price controls reduce the resources of American drug companies to finance drug and R&D innovation.” Trump added that “it’s very unfair to this country” and promised an America-first trade policy. “Our trade policy will prioritize that foreign countries pay their fair share for U.S.-manufactured drugs so our…… [read more]
Dr. Scott Gottlieb, President’s Trump’s nominee to head the Food & Drug Administration, has said the FDA displays an “unreasonable hunger for statistical certainty” and a “profound lack of confidence in the ability of doctors to make careful judgments.” In a bid to speed reviews and “change the FDA review culture itself,” Gottlieb proposed in a 2012 article that the FDA should follow the lead of its European Union counterpart, and let “a body of politically appointed (and therefore politically accountable) officials … ultimately [decide] on whether a new drug should be approved.” This week, as Gottlieb came before a…… [read more]
Senate has approved $15.25 billion in disaster aid in deal to extend debt limit and keep government open
BREAKING: The Senate has approved $15.25 billion in disaster aid as part of an agreement struck by President Trump and congressional Democrats that will also raise the federal borrowing limit and keep the government open until December 8. The House is expected to quickly vote on the package, despite growing opposition from fiscal conservatives who oppose pairing aid with debt and spending elements. The Senate package doubles the total amount of disaster aid approved by the House on Wednesday. This story will be updated. Senate Majority Leader Mitch McConnell (R-Ky.) speaks at the Capitol after President Trump overruled congressional Republicans…… [read more]
WASHINGTON (AP) – Sen. Elizabeth Warren delivered a ferocious attack Monday on congressional Republicans and Senate Majority Leader Mitch McConnell over a medical research bill, and put fellow Democrats on the spot by pushing them to oppose a measure she said “is corrupt, and it is very, very dangerous.” As Congress began the final stretch of its post-election session, Warren said the 996-page measure – a top priority for GOP leaders and backed by the biomedical industry – was riddled with provisions that she called “a bunch of special giveaways” to big pharmaceutical companies. “They didn’t send us here to…… [read more]
In June, pharmaceutical giant Genentech sent doctors a letter saying they should no longer prescribe a blockbuster drug called Tarceva to most patients suffering from lung cancer. A study had found that only a small number of patients — those with a certain gene mutation — might be helped by the drug, the company said. The news upended a 2010 decision by the Food and Drug Administration to greatly expand use of the $94,000-a-year drug, despite warnings from a panel of experts that said there was little evidence it actually worked. The FDA’s decision resulted in more harm than the…… [read more]
The Trump administration’s first budget proposes ending a program to encourage student-loan borrowers to go into public service by forgiving their debt to save an estimated $27 billion over the next decade. Here’s how the program works: If you take out a federal student loan, you have your loans forgiven after making 10 years of on-time payments and working for an employer the Department of Education deems to be serving the public good. Qualified employers include local, state and federal government agencies and nonprofit organizations. (Private lenders don’t offer this option.) show chapters This couple paid off their student loans…… [read more]
President Donald Trump’s vow to overhaul the Food and Drug Administration could bring major changes in policy, including steps to accelerate the process of approving new prescription drugs, setting up a clash with critics who say his push for deregulation might put consumers at risk. Trump has been vetting candidates to run the agency, which regulates the safety of things ranging from drugs and medical devices to food and cosmetics. Among them is Jim O’Neill, a former official at the Health and Human Services Department who is an associate of the Silicon Valley billionaire and Trump supporter Peter Thiel. O’Neill…… [read more]
CORE at Lakewood Ranch is intended to provide high-paying employment opportunities in the life-sciences sector. Dale White Staff Writer @dalewhiteHT LAKEWOOD RANCH – The developer Schroeder-Manatee Ranch received initial approval Thursday for “CORE at Lakewood Ranch,” a proposed biomedical research park that could collaborate with other institutions in the master-planned community such as Manatee Technical College and the Lake Erie College of Osteopathic Medicine. An acronym for “Collaboration Opportunities for Research and Exploration,” CORE is intended to provide high-paying employment opportunities in the life-sciences sector in an area that otherwise would remain approved for traditional retail, office and residential uses.…… [read more]
It takes 12 years, on average, to develop a prescription drug and get it approved for use by the Food and Drug Administration (FDA), according to pharmaceutical company Eli Lilly. Some experts and lawmakers say that’s too long. A bill now before Congress, the 21st Century Cures Act, would ease guidelines for certain drug and device approvals. If approved, it would also provide $10 billion over 10 years to the National Institutes of Health (NIH) to accelerate research efforts by providing grants to scientists working on potential new cures. READ MORE: The Top Earning Drugs in 2014 Made Tens of…… [read more]