Drugs

Republicans Introduce ‘Right to Try’ Bill

Reps. Andy Biggs (R-AZ) and Brian Fitzpatrick (R-PA) have introduced the Right to Try Act of 2017, which would allow terminally ill patients an option to receive drugs that have passed FDA’s “basic safety testing but are still working their way through the often lengthy bureaucratic process to final approval.” In a statement, Biggs says the bill is a companion to legislation introduced in the Senate by Sen. Ron Johnson (R-WI).

The congressmen say that right-to-try is already law in 33 states and the bill would ensure that the federal government, including FDA, does not interfere with those state laws. Biggs says the legislation includes these safeguards:

applies only to terminally ill patients and does not undo the current FDA approval process;
applies only to drugs that have gone through FDA Phase 1 safety testing;
requires physician certification that other options are exhausted or not available, thus maintaining incentives for patients to seek and join clinical trials;
ensures adverse outcomes are not held against pending pharmaceutical applications for FDA approval, thereby preventing drug companies from being discouraged to participate; and
precludes patients, doctors, and manufacturers from assuming any additional liability.

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