Politics, Policy & Law

House readies to vote on $2 trillion stimulus bill

The U.S. Senate passed a $2 trillion spending package late Wednesday, which appropriates $27 billion to HHS’s Public Health and Social Services Emergency Fund to combat COVID-19. The Coronavirus Aid, Relief, and Economic Security (CARES)...

Revamped Senate stimulus bill would provide $27B to HHS to combat pandemic

The U.S. Senate’s latest COVID-19 stimulus bill would appropriate $340 billion to support local and national agencies to combat the pandemic, including billions for biopharma R&D. HHS’s Public Health and Social Services Emergency Fund would...

Time for a 21st Century Manhattan Project

Politics, incompetence and disorganization got us into this mess. Science, solidarity and discipline can get us out of it. There’s already a blueprint for organizing science and industry to overcome an existential threat. It was...

FDA guidance encourages remote patient monitoring during pandemic

In response to the COVID-19 outbreak, FDA released guidance Friday encouraging companies and healthcare professionals to expand the use of remote monitoring technology to "help eliminate unnecessary patient contact and ease the burden on hospitals,...

Coronavirus bill includes antibiotic, net operating loss carryback, drug shortage provisions

The phase three coronavirus stimulus bill that is expected to be signed into law next week is likely to include provisions that are intended to stimulate development of antibiotics, relax limits on carrying back net...

NIH hits pause on non-critical lab work

NIH became the latest group to pare back its research due to the COVID-19 outbreak, following in the footsteps of multiple biopharmas that have paused preclinical and clinical programs this week. The organization will shift...

FDA urged to follow science, not hope, in quest for COVID-19 cures

Former FDA Commissioner Margaret Hamburg and FDA’s former Acting Chief Scientist Luciana Borio Thursday cautioned the agency to put science ahead of hope when responding to the COVID-19 pandemic. They spoke with BioCentury following public...

Former FDA Commissioners Gottlieb and McClellan propose actions to speed COVID-19 countermeasures

FDA should create task forces to facilitate the rapid development of point-of-care diagnostics, therapeutics and prophylactics for COVID-19, former FDA Commissioners Scott Gottlieb and Mark McClellan recommended in a working paper released Thursday. They also...

BIO hosting virtual summit to coordinate industry COVID-19 response

BIO is hosting a two-day virtual summit with companies that are developing COVID-19 medical countermeasures, government officials and other stakeholders. In addition to biopharma company representatives, White House Coronavirus Task Force Response Coordinator Deborah Birx;...

Grassley-Wyden drug price bill attacks rebates, includes inflation caps

A revised version of bipartisan Senate drug pricing legislation would pass Medicare Part D rebates to beneficiaries, rather than drug plans. The Congressional Budget Office estimates the Prescription Drug Pricing Reduction Act, co-sponsored by Sens....

Biotech CEOs respond to Sanders attack: science, not politics, will defeat the pandemic

Biopharma executives rebuked Sen. Bernie Sanders (I-Vt.) for attacking them and the biopharmaceutical industry Sunday evening during a debate with former Vice President Joe Biden. Science, not politics, will defeat COVID-19, industry leaders told BioCentury....

Patient access to new Alzheimer’s drugs will depend on diagnostic innovation and payment reform

If Biogen’s Alzheimer’s disease therapy aducanumab gets approved this year, it will set off a payment time bomb given the huge patient population, and the fact it almost exclusively falls in the Medicare age group....

U.S. moves to unlock COVID-19 test capacity

The U.S. government and industry took steps Friday to unlock COVID-19 testing capacity, including authorizing a commercial test, allowing New York to regulate tests conducted in the state, and funding development of two rapid diagnostics....

Insulin companies commit to CMS program that caps Medicare out-of-pocket insulin costs

The three major U.S. insulin suppliers, Eli Lilly, Novo Nordisk and Sanofi, said they will participate in a program CMS announced Wednesday that will cap out-of-pocket insulin costs for Medicare beneficiaries. CMS will allow enhanced...

White House backs limited Medicare drug reform legislation

The White House is backing a limited set of Medicare drug pricing reforms and hopes to have them included in legislation that is slated for enactment in May. Joe Grogan, director of the White House...