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House Outcome on 'Right to Try' Bill Uncertain

The House on Tuesday evening was poised to vote on a bill intended to give dying patients greater access to experimental treatments, but it was unclear whether Republican leaders had enough votes to pass it under a fast-track process. Even if it does pass, the sponsor of the Senate version said it was uncertain how the Senate might respond.

 

Bloomberg - Opposition to Experimental Drug Bill Unchanged Ahead of Vote

Terminally ill patients would be put at risk by changes to a House bill giving them access to experimental drugs, bioethicists and patients groups told Bloomberg Law.

 

The bill, set to be voted on in the House March 13, narrowed the Senate version’s definition of who could seek unapproved drugs. It also expanded the Senate version’s liability protections for drug companies and hospitals. Both bills give access to drugs that are in clinical trials and haven’t yet been approved by the Food and Drug Administration.

 

STAT - ‘Right-to-try’ law threatens patient safety and rational drug development

In President Trump’s first State of the Union address, he challenged Congress to give people who are terminally ill immediate access to experimental treatments without going through the FDA. A number of states have already passed such “right-to-try” laws. The Senate has passed a federal version, and a revised version is now under consideration in the House, with a vote likely on Tuesday.

 

Inside Health Policy - Funding Bill Allows HHS To Transfer Funds To FDA's Oncology Center Of Excellence

HHS will be able to transfer funds to FDA's Oncology Center of Excellence thanks to language included in the House Appropriations Committee's fiscal 2018 agriculture appropriations bill released Tuesday (June 27). Inside Health Policy had previously reported that FDA was using its existing funding to support OCE, and that the agency and the National Institutes of Health were exploring how to get resources transferred through the Economy Act (see related story).

Reuters - Trump chooses Gottlieb to run FDA

 

U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, the White House said on Friday.

 

If confirmed by the Senate, Gottlieb would be in charge of implementing Trump's plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco.

 

Washington Post - Trump calls the FDA ‘slow and burdensome,’ but it’s faster than ever

Two days before Christmas, the Food and Drug Administration gave Thomas Crawford an unexpected gift: approval of the first treatment ever for a devastating genetic disease that causes muscle wasting in babies and often results in death at an early age.

 

The drug “is nothing short of oh-my-God amazing” when given to infants who have not yet had symptoms, said Crawford, a Johns Hopkins pediatric neurologist who was involved in the clinical trials for the drug for spinal muscular atrophy.

STAT - Trump should unleash the FDA’s newest weapon against beating cancer

Our nation’s health regulators stand at a crossroads. In one direction lies advancement through cutting-edge programs; in the other are practices that no longer reflect our best scientific insight. Health officials want to move forward, but external conditions are holding them back.

 

President Trump can help our nation’s public health talent take the promising path forward by embracing groundbreaking regulatory reforms. Such audacious action will ensure America’s global leadership and national health.

 

Bloomberg BNA - FDA Mulling Ways to Break Silos, Review Products by Clinical Areas

The FDA is considering ways to review more medical treatments by clinical area, following in the steps of the cancer center established this summer.

 

“Historically, as almost everyone knows, FDA has been remarkably siloed,” Food and Drug Administration Commissioner Robert M. Califf said Nov. 4. “But what you hear loud and clear from patients is they’d like a have a way to be in contact with the FDA that’s not by product type but by what’s relevant to their disease. And we obviously heard that loud and clear from the cancer patients.”

 

Bloomberg - Cancer ‘Moonshot' to Harness Microsoft's Computing Power: Report

The White House's “moonshot” initiative to transform cancer care taps into industry giants from Microsoft and Amazon Web Services to ridesharing services Uber and Lyft, under a plan released Oct. 17.

 

Bloomberg BNA - Reliable Next-Gen Data May Avert FDA Review, Shuren Says

Formal FDA review may not be needed for interpreting results of advanced genetic screening tests if the associated databases contain reliable information, the agency's device chief said.

 

Jeffrey E. Shuren, director of the Center for Devices and Radiological Health, made the remarks while explaining the Food and Drug Administration's plan to regulate next-generation sequencing tests. These diagnostic tests, which can screen an entire genome to detect variations linked to diseases, are considered critical to the White House's precision medicine initiative.

 

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