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Daily News

December 10, 2020

Incoming House Appropriations Committee Chair Rosa DeLauro (D-CT) could play a key role in FDA-related spending decisions due to her close dealings with Rep. Sanford Bishop (D-GA), who heads the FDA appropriations subcommittee that DeLauro has previously chaired, the Alliance for a Stronger FDA suggests.

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House lawmakers on Wednesday (Dec. 9) introduced a bipartisan bill that would establish a subscription-style reimbursement model for antimicrobial drugs to incentivize drug makers to create new, innovative antibiotics by removing volume sales as the payment driver.

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Sanofi Pasteur may not charge the U.S. government more than other G7 countries for its coronavirus vaccine candidate, according to a redacted contract posted on HHS’ website.

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December 09, 2020

LabCorp’s Pixel COVID-19 Test Home Collection Kit became the first direct-to-consumer non-prescription COVID-19 diagnostic test to receive emergency use authorization from FDA, the agency announced Wednesday evening (Dec. 9).

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The House on Wednesday (Dec. 9) passed a one-week government funding extension as lawmakers continue to negotiate a potential COVID-19 relief package and stakeholders push to get their priorities, like a fix for pay cuts to certain physicians and a continued moratorium on the Medicare sequester, into an end-of-the-year bill.

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The White House Office of Management and Budget on Monday (Dec. 7) finished reviewing a final rule to put in place a 340B administrative dispute resolution process, after having previously withdrawn a proposed rule on the issue, raising questions about how the Trump administration can legally move forward with a final rule.

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The House on Wednesday (Dec. 9) passed by voice vote a bipartisan bill that would require FDA and the National Institute on Drug Abuse to issue guidelines on the production of marijuana, as part of the legislation’s larger goal to make marijuana accessible to be studied for medical purposes.

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FDA biologics center director Peter Marks said the agency is working with its colleagues in the United Kingdom to understand why two U.K. health care workers experienced severe allergic reactions to Pfizer’s COVID-19 vaccine, and he said the agency will discuss the issue with its advisers during the agency’s Thursday (Dec. 10) advisory committee meeting.

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Xavier Becerra, President-elect Joe Biden’s nominee for HHS secretary, recently asked the federal government to use a controversial monopoly-busting mechanism to lower the cost of the COVID-19 drug remdesivir, and there are several COVID-19 drugs and vaccines that are susceptible to the government’s so-called march-in rights.

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Former HHS Secretaries Donna Shalala and Kathleen Sebelius expressed confidence that President-elect Joe Biden’s HHS pick, Xavier Becerra, will gain enough bipartisan support to be confirmed, stressing that even though the California attorney general is a strong proponent of Medicare for All, he is a team player who will be dedicated to the less-aggressive policy of shoring up and building off the Affordable Care Act per Biden’s approach.

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HHS’ latest application of the PREP Act allows doctors to provide certain COVID-19 pandemic-related services via telehealth across state lines -- effectively allowing the providers to avoid long-standing cross-state licensure requirements for a limited number of services.

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Policymakers could help drive down Affordable Care Act premiums by letting smaller, mission-driven Medicaid managed care insurers sell exchange plans to a limited number of enrollees at first and then expand as capital allows, says the lobby that represents safety net plans.

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A coalition of employers and other health care stakeholders dedicated to protected job-based coverage asks Congress to include in the COVID-19 relief package under discussion 10 policies that would provide quick relief and help people keep coverage, including axing the mandate that consumers refund subsidy overpayments, funding 95% of COBRA costs and more.

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CMS will reinstate for certain beneficiaries the 5% weight loss eligibility requirement for the Medicare Diabetes Prevention Program that was waived in March due to the COVID-19 emergency, but suppliers are concerned beneficiaries’ access to gyms or healthy food choices has been limited due to the pandemic and few have access to the technology CMS requires to report their weight loss.

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December 08, 2020

FDA and Pfizer are clashing again over whether COVID-19 vaccine trials should be unblinded once a vaccine has emergency use authorization.

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President-elect Joe Biden said Tuesday (Dec. 8) his three priorities for his first 100 days in office are: a federal mask mandate, administration of 100 million COVID-19 vaccines and opening of schools.

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United Healthcare tells Inside Health Policy that the insurer is offering exchange plans in eight states for the 2021 plan year.

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President Donald Trump on Tuesday (Dec. 8) said his administration will consider invoking the Defense Production Act if there are any problems with manufacturing enough COVID-19 vaccines for U.S. citizens, coming amid reports that the U.S. government did not take the opportunity to buy more doses from Pfizer over the summer and that the drug makers’ remaining doses through next June have been allocated to other countries.

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Senior White House administration officials denied a recent New York Times report that alleged the Trump administration passed up the opportunity to purchase more doses of Pfizer’s COVID-19 vaccine and as a result Pfizer now might be unable to provide more of its vaccine to the United States until next June because of its commitments to other countries.

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A pharmaceutical economics professor says the federal government should consider creating an agency, separate from FDA, of which the sole purpose would be to track drug use, create multiple drug shortage lists and develop shortage mitigation strategies.

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