Taking a breather from the political rhetoric that’s permeated the U.S response to COVID-19 and pushed legislation aimed at lowering drug prices to the back burner, a House subcommittee Wednesday advanced several bipartisan bills intended to improve the safety and ensure the supply of drugs and medical devices.
U.S. FDA commissioner Stephen Hahn appeared before a congressional panel to discuss the administration’s budget proposal for the agency, but the outbreak of COVID-19 predictably dominated the proceedings.
The Office of the National Coordinator (ONC) and CMS both posted their final rules for electronic health records (EHRs), and analysts with Cowen Washington Research Group said both rules essentially replicate the draft versions. The provisions dealing with data blocking and interoperability are expected to benefit developers of HER systems in the near term, and telehealth should also benefit, albeit over a longer scale of time.
Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.
LONDON – The World Health Organization (WHO) has released its COVID-19 R&D roadmap, highlighting the gaps in knowledge about the virus and setting out priorities for research. The organization is now calling on groups around the world to use the document – drawn up by 400 experts – to coordinate their efforts.
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.
The March 4 congressional hearing on the budget for the NIH was peppered with questions about the COVID-19 outbreak, although the general sentiment is that the agency will receive yet another boost in appropriations in fiscal 2021.
Against the backdrop of the global spread of COVID-19, India announced restrictions Tuesday on the export of 26 active pharmaceutical ingredients (APIs) and formulations of those ingredients.
COVID-19 is bringing more pressure to bear on Congress to pass S. 2723, the Mitigating Emergency Drug Shortages (MEDS) Act, which has been sitting in the Senate Health, Education, Labor and Pensions (HELP) Committee since Sen. Susan Collins (R-Maine) introduced it in October 2019 – a few months before the novel coronavirus emerged.
LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths.