Drugs

Gottlieb Wants ‘Right-to-Try’ Changes: CNBC

CNBC reports that despite pressure from President Donald Trump for Congress to pass “right-to-try” legislation giving terminally ill patients access to experimental drugs, FDA commissioner Scott Gottlieb is seeking changes in the legislation. In 8/2017, CNBC reports, the Senate passed on a unanimous vote a bill allowing anyone facing a “life-threatening disease or condition” to access experimental treatments.

That measure is now facing changes in the House, and it is likely that a modified or totally new bill will ultimately be sent back to the Senate, the report says. Gottlieb reportedly has said he wants the Senate bill’s language narrowed to people facing “terminal illness.”

The report references the current FDA compassionate use or expanded access program, noting that the agency has approved 99.7% of those requests and that it has taken steps to streamline and speed the application process.

“Currently, when unapproved drugs are administered to patients for research purposes, important ethical and safety mechanisms are in place,” American Cancer Society Action Network spokesperson Alissa Crispino told CNBC. She said that right-to-try “removes important safety protections and creates openings for bad actors to take advantage of patients.”

Terminally ill cancer patient Michael Becker, who formerly was president of the drug company Cytogen, said in an online first-person account referenced by CNBC that “people like me already have access to experimental therapies. Cutting out FDA as a gatekeeper increases the risk of patients being harmed through the peddling of false hope and snake oil.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome