The House sent “right to try” legislation on experimental drugs to President Trump’s desk Tuesday — a measure Trump, Vice President Pence and groups backed by mega-donors Charles and David Koch have repeatedly urged Congress to pass. The House passed the bill largely along party lines by a 250-169 vote. Twenty-two Democrats broke…
The House passed legislation on Tuesday that would give terminally ill patients the right to try experimental treatments, sending a major White House priority to President Trump’s desk after several false starts. The bill, which passed 250-169 and has been a priority for conservative think tanks and outside groups, now goes to Trump, who…
Patients with life-threatening conditions could soon have a new way to ask drug makers for medicines the Food and Drug Administration hasn’t yet approved, after the House on Tuesday voted to approve a version of “right-to-try” legislation. The House passed the legislation 250-169. Now, the measure awaits a signature from President Trump, who repeatedly…
Academic researchers found FDA has approved precision medicines 1.7 years faster on average than nonprecision medicine and with substantially less premarket evidence, which they cautioned could expose patients to unknown risks and uncertain benefits. While the decreased review time speeds up marketing and lowers development costs, it also necessitates waiting for years to collect postmarket…
Health care organizations and companies representing patients, providers, laboratories and diagnostic manufacturers called on Senate and House leaders to advance legislation that would reform and modernize the process for bringing innovative diagnostics and clinical laboratory tests to market. In a letter to the chairmen and ranking members of the Senate Committee on Health, Education,…
A coalition of over 80 groups, including manufacturers, providers, laboratories and patient advocates, sent a letter Wednesday (May 9) to key members of Congress attempting to create momentum around passing legislation in 2018 revising government oversight of diagnostics, including laboratory developed tests (LDTs). The unified call for congressional movement comes as FDA is providing…
The FDA’s push to use real-time data for evaluating drugs and devices could bring about more useful electronic medical records that improve patient care, current and former commissioners said May 4. The Food and Drug Administration is asking Congress for $100 million in its 2019 budget to build a database of 10 million individual…
On the heels of FDA’s first approval of a tissue-agnostic cancer treatment, cancer research advocates are eagerly awaiting an FDA public workshop scheduled for May 9 on the scientific and regulatory issues associated with granting orphan drug designation to these therapies. The head of a major cancer think tank hopes the meeting will provide some…
The FDA may be creating expectations among seriously ill patients that are unlikely to be fulfilled by designating new cancer drugs as breakthrough therapies, a Harvard Medical School faculty member told Bloomberg Law. Jonathan J. Darrow was taking aim at an almost six-year-old program that allows drug companies to get their medicines reviewed by the…
The idea of a breakthrough therapy was promoted to speed approvals of medicines that held promise for treating a life-threatening disease and demonstrated substantial improvement over existing drugs. However, a new study finds that while cancer drugs considered to be breakthroughs were approved more quickly, they were not safer, more novel, or more effective than…
