ACA Repeal Falls Short, Skyrocketing Drug Prices, & A New Digital Health Innovation Action Plan From The FDA
This week’s BioBlog explores many topics related to the biopharmaceutical industry and the Affordable Care Act. Articles on 340B program, the approval of Celgene and Agios’ enasidenib (AG-221), the rising costs of drugs, and other issues directly impacting healthcare throughout America demonstrate the continued need for reform and innovation in the broader healthcare industry.
The American Society of Clinical Oncology (ASCO) recently sent a letter to the leadership team of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigation expressing support to curb the improper application of the 340B Drug Pricing Program. However, ASCO also expressed concern that 340B remains within the intended project scope.
Gottlieb to delay issuing layoff notices and reassures FDA staff that Congress will reauthorize user fees
FDA commissioner Scott Gottlieb announced he will delay layoffs until after September 30th. Previously, it was thought that layoffs would commence in August. The agency is awaiting the Senate’s confirmation of the bill to reauthorize user fee programs.
In a surprising turn of events, the Senate failed to pass a repeal of the Affordable Care Act (Obamacare). Video and article commentary on the story is available on the Boston Globe.
About 5.9 million people or about 57% of everyone enrolled in the Affordable Care Act receives a subsidy. This article explores details of the population who stand to lose their subsidy if the Trump administration halts cost-sharing reduction subsidies to low income people.
Everyone loves to complain about the soaring cost of prescription drugs, but what is really behind the increasing prices? This piece is an exploration of the interplay between pharmacy benefits managers, drug companies, and other players in the situation concerning the rising cost of medications.
Celgene and Agios received a swift FDA decision on enasidenib (AG-221), their new therapy for acute myeloid leukemia. The drug, now called Idhifa, focuses on about 9% to 13% of the AML market.
The FDA recently unveiled a new publication entitled Digital Health Innovation Action Plan. In it, the agency outlines their efforts to ensure that all consumers and health agencies have access to safe, high quality, and effective digital health products. This includes software for consumers, technology that facilitates communications among service providers, and products that help clinical practices manage their workflows.