OSHA Touts COVID Settlement Mandating Disease Plans At Seven Meat Plants

The Occupational Safety and Health Administration says it has secured a settlement agreement with several subsidiaries of the food-processing giant JBS Foods that will mandate infection-control plans at seven plants across six states, after COVID-19 outbreaks at two of the facilities in 2020 led to seven worker deaths and hundreds of confirmed infections. On May 27, OSHA announced that “four subsidiaries and affiliates” of JBS have agreed to develop and implement a single “infectious-disease preparedness plan” at all seven plants...
Article Type: 
Daily News
Tags: 
corona
food-safety
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 06/03/2022
FDA Volume: 
Vol. 28, No. 22
Author: 
David LaRoss
Topics: 
ISSUE: FDA WEEK
Coronavirus
Food Safety

JAMA: Govt. Spends Billions On Drugs Without Proven Clinical Benefit

From 2012 through 2020, Medicare and Medicaid spent $40 billion on drugs that received accelerated approvals from 2012 to 2017 and were later converted to standard FDA approvals based on clinical trials that evaluated surrogate endpoints, and the government spent another $14 billion on accelerated approval drugs that were not converted to standard approvals, according to a study published in the Journal of the American Medical Association . “These findings suggest that drugs that are granted accelerated approval were...
Article Type: 
Inside Drug Pricing Daily News
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 06/06/2022
IDP Volume: 
Vol. 5, No. 23
Author: 
John Wilkerson

FDA Ends Pre-Cert But Could Revisit In The Future, With Congress’ Help

FDA recently decided to end its device software precertification pilot program and hand development over to the Medical Device Innovation Consortium, saying it needs additional authority from Congress to implement the program as envisioned, but it may not be the end of the road for the initiative. One former FDA official believes the agency may eventually try to revisit the pre-cert program, though he acknowledged it could take years, especially as Congress would need to sign off. “Congress can actually...
Article Type: 
Daily News
Tags: 
device-approval
device-trial
mhealth
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 06/03/2022
FDA Volume: 
Vol. 28, No. 22
Author: 
Kelly Lienhard
Topics: 
ISSUE: FDA WEEK
Mid Day E-mail
Medical Devices

White House Launches HHS Office Dedicated To Environmental Justice

The White House has established an HHS office charged with protecting the health of vulnerable communities by dealing with pollution, climate change and other environmental issues. The new office will be part of the Office of Climate Change and Health Equity, which President Biden created by executive order in 2021 . The Office of Environmental Justice will serve as “the HHS-wide hub for environmental justice policy, programming, and analysis,” the White House announced Tuesday (May 31). It will lead initiatives...
Article Type: 
Daily News
Tags: 
health-equity
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 06/03/2022
FDA Volume: 
Vol. 28, No. 22
CMS Issue: 
Inside CMS - 06/02/2022
CMS Volume: 
Vol. 25, No. 22
Author: 
Jessica Karins
Topics: 
ISSUE: INSIDE CMS
ISSUE: FDA WEEK
Mid Day E-mail
Health Equity

USTR Again Extends Tariff Exclusions For Medical-Care Products From China

The Office of the U.S. Trade Representative has again extended exclusions from Section 301 tariffs granted to some medical-care products considered vital to efforts to combat COVID-19. In a Federal Register notice, USTR notes that its November 2021 extensions of most of the exclusions, which initially were granted in December 2020, were set to expire on May 31. The notice says the exclusions, covering 81 product types, will be extended another six months. “In light of the continuing efforts...
Article Type: 
Daily News
Tags: 
corona
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 06/03/2022
FDA Volume: 
Vol. 28, No. 22
Author: 
Dan Dupont
Topics: 
ISSUE: FDA WEEK
Mid Day E-mail
Coronavirus
Medical Devices

FTC, DOJ To Hold Event On Antitrust Enforcement Of Drug Industry

The Federal Trade Commission and the Justice Department will hold a two-day meeting starting June 14 to explore new ways to enforce the antitrust laws affecting the pharmaceutical industry, FTC announced Tuesday (May 31) . It’s not clear whether antitrust enforcement of pharmacy benefit managers will come up because the agenda is still being worked out, but an FTC spokesperson said the commission is interested in PBMs regardless of whether PBM policy is a prominent topic at the event. On...
Article Type: 
Inside Drug Pricing Daily News
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 06/06/2022
IDP Volume: 
Vol. 5, No. 23
Author: 
John Wilkerson

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