Senate sets up Califf confirmation vote with narrow procedural win

Senate sets up Califf confirmation vote with narrow procedural win-rollcall:  The Biden administration’s nominee to lead the Food and Drug Administration, Robert Califf, survived a Senate procedural vote, 49-45, on Monday evening with the help of five Republicans.

Biden’s FDA pick makes major ethics pledges to win over Elizabeth Warren

Biden’s FDA pick makes major ethics pledges to win over Elizabeth Warren-politico:  President Joe Biden’s nominee to lead the Food and Drug Administration is making major ethics concessions to Sen. Elizabeth Warren as he tries to lock down critical confirmation votes.

Senate panel advances Biden's FDA pick in 13-8 vote

Senate panel advances Biden's FDA pick in 13-8 vote-politico:  The Senate HELP Committee voted 13-8 to advance Robert Califf's nomination to head the Food and Drug Administration, putting the Biden administration one step closer to installing a permanent leader at an agency critical to the pandemic response.

Biden nominates Califf as FDA chief

Biden nominates Califf as FDA chief-politico:  President Joe Biden on Friday nominated former Commissioner Robert Califf to lead the Food and Drug Administration, in a move that would bring the Obama-era official back for a second tour atop the agency.

Controversial drug approval stokes concern about lack of a permanent FDA chief

Controversial drug approval stokes concern about lack of a permanent FDA chief-politico:  The Food and Drug Administration’s approval of a controversial new Alzheimer’s drug this week has hardened opposition to acting commissioner Janet Woodcock, who remains President Joe Biden’s apparent favorite to be the agency’s permanent leader.

How the bitter political fight over painkillers could derail Biden's FDA pick

How the bitter political fight over painkillers could derail Biden's FDA pick-politico:  Joe Biden’s pick to head the Food and Drug Administration was supposed to be an easy one.  But two months into his presidency, the search for a commissioner to run a health agency critical to the pandemic response has become a drawn-out and messy affair, vexing administration officials and threatening to disrupt a rare period of harmony on health care within the Democratic Party, according to more than a half-dozen current and former officials and people familiar with the deliberations.

FDA commissioner race could test pharmaceutical industry’s sway

FDA commissioner race could test pharmaceutical industry’s sway-rollcall:  A tug of war over who should lead the Food and Drug Administration at a critical moment has become a referendum on how the value of agency experience stacks up against new perspectives on how the FDA should regulate the pharmaceutical industry.

Trump health official’s approach to contracts faces scrutiny

Trump health official’s approach to contracts faces scrutiny-rollcall: A company that won a $628 million contract from the Department of Health and Human Services last week is one Robert Kadlec, the official who leads the agency's pandemic response, knows well.

New FDA chief plans for "the most serious scenarios" of coronavirus outbreak-

New FDA chief plans for “the most serious scenarios” of coronavirus outbreak-politico: New FDA commissioner Stephen Hahn faced a jam-packed agenda: opioids, CBD, vaping, and how to let states safely import drugs. Then the Wuhan coronavirus broke out.

Trump bets on Washington outsider to lead FDA amid political battles

Trump bets on Washington outsider to lead FDA amid political battles-politico: President Donald Trump is betting on a Washington outsider to navigate a series of hot-button health care issues at the center of his 2020 campaign: a vaping crisis, an ambitious plan to import drugs and a raging opioid epidemic. Stephen Hahn, a longtime cancer researcher and Trump’s new pick to lead the FDA, would be thrust into the middle of high-profile debates that have plagued the administration and stoked outrage on Capitol Hill if he is confirmed. The political stakes are high for Trump, who’s sought to claim health care as a top reelection issue.

FDA funding set to jump as Congress votes to avert shutdown

FDA funding set to jump as Congress votes to avert shutdown-fiercebiotech: Congress has approved a budget deal to avert another government shutdown. The deal, which was signed into law on Friday by President Trump, includes the biggest increase in FDA funding in several years.

US FDA back in business after shutdown, but regulatory work has 'piled up'

US FDA back in business after shutdown, but regulatory work has 'piled up'-spglobal: After 35 days of having about half of its employees either fully or partially furloughed, the U.S. Food and Drug Administration is back in business, though its leaders acknowledged the shutdown has put the agency behind in its regulatory work.

Could the FDA keep working without more funding, if drug reviews are deemed essential to protecting lives?

Could the FDA keep working without more funding, if drug reviews are deemed essential to protecting lives?-stat: Two former Food and Drug Administration lawyers have a creative possibility for how the agency could continue to do some of its work if the shutdown drags on: argue that reviewing certain drugs is essential to protecting people’s lives.

FDA directs dwindling resources toward reviewing new drugs

FDA directs dwindling resources toward reviewing new drugs-washingtonpost: The Food and Drug Administration plans to furlough more people and suspend lower-priority tasks to preserve money for drug reviews, including for new treatments for depression, diabetes and several types of cancer.

FDA Is Revamping Clearance Procedures for Medical Devices

FDA Is Revamping Clearance Procedures for Medical Devices-wsj: The Food and Drug Administration is significantly revamping the way it clears most medical devices for U.S. marketing, planning to rely far less on comparisons with much older products already on the market.

Decrying political pressure at FDA, former commissioners push a breakaway plan

Decrying political pressure at FDA, former commissioners push a breakaway plan-stat: A bipartisan group of seven former FDA Commissioners are uniting to advocate for breaking the Food and Drug Administration out of the Department of Health and Human Services and making it an independent agency.

White House proposes a narrowing of FDA’s mission — and a new name

White House proposes a narrowing of FDA’s mission — and a new name - The Trump administration has proposed a fundamental change to the mission of the Food and Drug Administration, one that would transfer most of the responsibility for regulating food safety to the Department of Agriculture and rename the FDA the “Federal Drug Administration.

House passes Trump-backed drug bill, letting sick patients bypass FDA

House passes Trump-backed drug bill, letting sick patients bypass FDA: The House on Tuesday approved a right-to-try drug bill that would allow terminally ill patients nationwide to directly request experimental treatments from drugmakers, a libertarian-inspired effort that captured the personal interest of President Donald Trump and Vice President Mike Pence.

US regulators float ideas for boosting medical device safety

US regulators float ideas for boosting medical device safety-ap: U.S. health officials on Tuesday proposed steps to improve the government’s system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments.

Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny

Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny-nytimes: Trump administration officials, seeking ways to lower drug costs, are targeting pharmaceutical companies that refuse to provide samples of their products to generic drug companies, making it impossible to create inexpensive generic copies of a brand-name medicine.