Drugs

House Bill Introduced to Lower Drug Costs

Republican House lawmakers have introduced the Lower Costs, More Cures Act (H.R. 19) to lower drug costs for Americans without limiting access to cures. The bill “uses bipartisan reforms to lower out-of-pocket spending, protect access to new medicines and cures, strengthen transparency and accountability, and champion competition,” they say in a release. The measure was introduced by Greg Walden (R-OR), Kevin Brady (R-TX), Virginia Foxx (R-NC), and Doug Collins (R-GA).

The legislation includes a number of provisions affecting FDA. For example, Subtitle A includes provisions that allows for actions against bad actors who delay generics and biosimilars coming to market by withholding drug samples. Another provision is aimed at changing conditions of first generic exclusivity to spur access and competition. The is also an Over the Counter Monograph Safety, Innovation, and Reform Section that would provide new authorities to the FDA aimed at increasing the number of over-the-counter products available. Additionally, there are provisions on biosimilars, and reducing “evergreening” by restricting manufacturers from obtaining new exclusivities on previously approved chemical entities.

Click here for a section-by-section summary of the Lower Costs, More Cures Act.

Click here for legislative text of the Lower Costs, More Cures Act.

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

Read more

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