After nearly three months of the U.S. federal government operating on stopgap spending measures, Congress has agreed to a $1.4 trillion spending bill for fiscal 2021. The omnibus package, which includes $97 billion for the Department of Health and Human Services, gives both the FDA and NIH small increases in funding.
The Senate passed by a vote of 96-1 the spending bill for the outbreak of the new coronavirus (COVID-19), which will be on President Donald Trump’s desk by week’s end. The bill provides $7.8 billion in new funds to tackle the outbreak and another $490 million in existing funds for telehealth, all with the aim of speeding the response to the pathogen.
One sentence buried more than 1,500 pages into a fiscal 2020 spending bill the U.S. Senate passed Thursday could open the door to a broader range of insulin biosimilars. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides.
One sentence buried more than 1,500 pages into a fiscal 2020 spending bill the U.S. Senate passed Thursday could open the door to a broader range of insulin biosimilars. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides.
The U.S. House of Representatives passed two spending packages that boosted funds for both the FDA and the NIH, but device and generic drug makers saw other benefits. The House legislation would allow makers of biosimilars and generic drugs to sue brand names for blocking access to the index article, but also repealed the medical device tax, a change that would bolster development of the novel therapies that are the industry’s lifeline. Both spending bills carry numerous provisions related to the health care economy and will go to the Senate for passage, hopefully before the government runs out of money Dec. 20.
The U.S. House of Representatives passed two spending packages that boosted funds for both the FDA and the NIH, but generic drug makers and device makers saw other benefits. The two bills not only repealed the medical device tax, but also would allow makers of biosimilars and generic drugs to sue brand names for blocking access to the index article, a move intended to tamp down on the cost of small-molecule pharmaceuticals and biotech therapies.