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Rx Drugs

January 22, 2021 | Daily News

The White House Office of Management and Budget pulled six FDA guidances and rules from its review, a move prompted by President Joe Biden’s freeze on all regulations issued by the Trump administration that have not yet gone into effect.

January 22, 2021 | Daily News

One of President Joe Biden’s executive orders out Thursday steps into the still smoldering issue over coverage of non-diagnostic COVID-19 testing, demanding that HHS clarify insurers’ responsibilities.

January 22, 2021 | Daily News

White House Press Secretary Jen Psaki confirmed Friday (Jan. 22) the Defense Production Act has been invoked and processes to ramp up COVID-19 response supplies, including vaccine and test supplies, are “rapidly ongoing,” coming as New York officials say the state is on the verge of running out of its first-dose batches.

January 22, 2021 | Daily News

Eli Lilly will pursue an expanded emergency use authorization for its monoclonal antibody, bamlanivimab, the company said Friday (Jan. 22) as it revealed that data from an ongoing trial suggest the therapy reduced long-term care facility residents’ risk of contracting symptomatic COVID-19 by 80% compared with those who did not receive the therapy.

January 21, 2021 | Daily News

HHS is freezing for 60 days an 11th-hour final rule from the Trump administration that makes certain health clinics pass 340B discounts on insulin and epinephrine to patients -- but health clinics say the rule might raise prices for some patients.

January 21, 2021 | Daily News

President Joe Biden on Thursday (Jan. 21) signed an executive order directing HHS and other agencies involved in COVID-19 response to take immediate action using all available authorities, including using the Defense Production Act, to fill vaccine, testing and personal protective equipment supply gaps and to take steps to address the pricing of pandemic response supplies.

January 21, 2021 | Daily News

The House Energy & Commerce health subcommittee, and possibly the oversight subcommittee, are expected to hold coronavirus hearings the week of Feb. 1, according to lobbyists.

January 21, 2021 | Daily News

The Senate Finance Committee on Thursday (Jan. 14) released a bipartisan report that blames both drug companies and pharmaceutical benefit managers for rising insulin prices.

January 21, 2021 | Daily News

The Maryland legislature last week overrode GOP Gov. Larry Hogan’s veto of funding for the nation’s first state board created to make drugs affordable.

January 19, 2021 | Daily News

CMS is using a demonstration to weaken two pillars of patient protections in Part D: protected drug classes and the requirement that insurers cover at least two drugs in each class.

January 19, 2021 | Daily News

FDA chief Stephen Hahn blasted an 11th-hour agreement that HHS penned with the U.S. Department of Agriculture shifting FDA’s regulation of animal food biotechnology products to USDA, with the outgoing FDA head vowing his agency will continue to oversee genetically modified animals intended for human consumption.

January 19, 2021 | Daily News

New York Gov. Andrew Cuomo (D) wants to purchase COVID-19 vaccine doses directly from Pfizer rather than waiting for allocations from the federal government, but HHS, which has to give Pfizer permission to sell directly to state governments, isn’t on board with the idea.

January 15, 2021 |

President-elect Joe Biden on Friday (Jan. 15) outlined his plan to expand the availability of and access to COVID-19 vaccines by releasing most of the available doses in reserve, invoking the Defense Production Act to ensure there’s a robust supply, expanding vaccine eligibility to people ages 65 and over, and standing up more vaccination centers across the country and launching mobile vaccination clinics.

January 15, 2021 | Daily News

President-elect Joe Biden on Friday (Jan. 15) outlined his plan to expand the availability of and access to COVID-19 vaccines by releasing most of the available doses in reserve, invoking the Defense Production Act to ensure there’s a robust supply, expanding vaccine eligibility to people ages 65 and over, and standing up more vaccination centers across the country and launching mobile vaccination clinics.

January 15, 2021 | Daily News

Incoming Senate health committee Chair Patty Murray (D-WA) has asked HHS Secretary Alex Azar to rescind all the policies it has imposed on FDA in recent months and to defer to FDA for all future agency policy changes, according to a Thursday (Jan. 14) letter obtained by Inside Health Policy.

January 14, 2021 | Daily News

President-elect Joe Biden’s $1.9 trillion COVID-19 relief proposal unveiled Thursday (Jan. 14) calls on Congress to subsidize COBRA coverage through September and to implement one of Biden’s major health agenda items: increasing and expanding the Affordable Care Act’s tax credits.

January 14, 2021 | Daily News

President-elect Joe Biden late Thursday (Jan. 14) unveiled a $1.9 trillion COVID-19 relief package that would pump $20 billion into a national vaccination program that results in 100 million vaccinations by the end of his first 100 days.

January 14, 2021 | Daily News

HHS is exempting physicians from certain certification requirements needed to prescribe buprenorphine for opioid use disorder, the department announced Thursday (Jan. 14).

January 14, 2021 | Daily News

The Pharmaceutical Research and Manufacturers of America is pausing political donations to Republicans who voted against certifying the presidential election.

January 14, 2021 | Daily News

Advocates for lower drug prices say the Commerce Department’s eleventh-hour proposal to prohibit the government from using high prices as a reason to license third parties to make drugs and vaccines developed with federal funding is a give-away to the drug industry.

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