Drugs

Problem Solvers Caucus Drug Price Principles

Members of the congressional Problem Solvers Caucus, 23 Democrats and 23 Republicans from both the House and the Senate, have released a list of seven principles for supporting prescription drug pricing legislation. A media statement from Sens. Susan Collins (R-ME) and Joe Manchin (D-WV) said legislation to address the country’s constantly rising prescription drug prices would also boost access to healthcare nationwide, increase price transparency, and grow competition. The principles are:

support access to medications for patients through more transparency, competition, and affordability in the U.S. prescription drug market;
support price transparency standards that give patients, healthcare providers, and the federal government clear information about drug costs;
believe drug manufacturers should have to disclose, in a way consumers and providers can understand, the price of treatment for advertised drugs and explanation of prices;
believe pharmacy benefit managers should have to disclose, in a way consumers and providers can understand, the discounts they receive from drug manufacturers that affect the cost of medications for patients;
support patent transparency standards that help new drugs come to market as soon as possible;
support competition among drug manufacturers that ensures continued research and development, makes drugs more affordable, and increases access for patients who need them; and
believe in enforcement mechanisms that pave the way for new, more affordable drugs if other manufacturers do not comply with transparency standards or engage in anti-competitive behavior.

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