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Rx Drugs

November 09, 2020 | Daily News

President-elect Joe Biden congratulated the “brilliant women and men” at Pfizer and BioNTech after the companies on Monday (Nov. 9) announced their coronavirus vaccine showed 90% effectiveness in the first interim analysis of the phase 3 trial.

November 06, 2020 | Daily News

The Health Resources and Services Administration asked Eli Lilly in June to rethink its plan to stop 340B discounts for certain drugs supplied via contract pharmacies but the agency stopped short of declaring the policy illegal, according to internal correspondence between HRSA and Eli Lilly obtained by Inside Health Policy.

November 05, 2020 | Daily News

With most members of the House oversight committee returning to Congress next year, as well as those on the special COVID-19 investigative panel, the committee is expected to focus on pandemic issues, including the distribution of relief funds and the vaccine approval and distribution process, in addition to drug pricing.

November 05, 2020 | Daily News

No matter the outcome of the election, the drug industry will be exposed to reforms that could hurt its profits as lawmakers seek offsets for the costly task of dealing with the wave of people losing insurance due to the pandemic and the more than 20 million people whose coverage could be disrupted if the Supreme Court strikes the Affordable Care Act this summer, lobbyists and analysts say.

November 04, 2020 | Daily News

As of Wednesday afternoon (Nov. 4), it was unclear which party will take control of the Senate, but either way the Senate health committee will experience a change in leadership, as committee Chair Lamar Alexander (R-TN) will retire at the end of the year.

November 03, 2020 | Daily News

The American Hospital Association is concerned that drug manufacturers could use Kalderos’ 340B Pay system to turn the 340B program from a discount program, where providers pay a lower price for drugs, into a rebate program where manufacturers return funds to providers after the drug makers verify that the lower prices are valid.

November 03, 2020 | Daily News

Johnson & Johnson has resumed its phase 3 COVID-19 vaccine study in the United States and in some countries in Latin America, a spokesperson for the company told Inside Health Policy on Tuesday (Nov. 3).

November 02, 2020 | Daily News

Both President Donald Trump and Democratic nominee Joe Biden want to allow Americans to save money by importing prescription drugs from Canada, but such a policy might not matter in a Biden administration if Congress passed a policy allowing Medicare to negotiate cheaper drug prices, drug policy experts say.

October 30, 2020 | Daily News

CMS is asking for feedback on a proposal to add coronavirus vaccination rates to performance measures that determine whether Medicare Advantage and Part D plans receive bonuses because the agency believes health plans will play a crucial role in encouraging seniors to get the vaccine.

October 30, 2020 | Daily News

FDA on Friday (Oct. 30) released a list of 223 essential drugs and biologics and 96 device medical countermeasures, nearly three months after the White House directed the agency to issue the list as part of the Trump administration’s so-called buy American executive order that was signed in August.

October 30, 2020 | Daily News

Novartis scaled back its earlier plan to restrict 340B discounts on drugs accessed through contract pharmacies after stakeholders complained.

October 29, 2020 | Daily News

The Trump administration’s final rule requiring insurers to reveal their negotiated prices with providers received quick praise from Republicans and some employers, but key health insurance lobbies said the rule is flawed and will increase, not lower, costs for consumers.

October 29, 2020 | Daily News

FDA has entered into a three-year collaborative agreement with Emulate under which multiple centers within the agency will study the biotechnology company’s Organ-Chips technology to evaluate COVID-19 vaccines and therapies and study the human immune response to SARS-CoV-2, Emulate announced Thursday (Oct. 29).

October 29, 2020 | Daily News

CMS is making group and individual health plans inform enrollees of their out-of-pocket drug costs and whether copay coupons and other forms of financial assistance count toward deductibles and out-of-pocket maximums.

October 29, 2020 | Daily News

Pfizer will likely say whether its coronavirus vaccine works after the election, Pfizer CEO Albert Bourla said Tuesday (Oct. 27), then by the end of November the company hopes to apply for emergency use authorization.

October 28, 2020 | Daily News

Coronavirus vaccines will be free to all Medicare beneficiaries because Medicare will cover, in entirety, the up to $2.6 billion cost of paying doctors to administer coronavirus vaccines, and doctors will bill traditional Medicare for all beneficiaries so private Medicare Advantage plans do not need to cover the cost, CMS Administrator Seema Verma said Wednesday (Oct. 28).

October 28, 2020 | Daily News

HHS announced plans Wednesday (Oct. 28) to pay Eli Lilly up to $1.187 billion for 950,000 vials of a coronavirus antibody drug, on the condition that FDA authorizes it for emergency use, which would come out to $1,250 per treatment, similar to the $1,500 price per treatment of Regeneron’s experimental antibody drug.

October 28, 2020 | Daily News

Former FDA chief Scott Gottlieb warned that the federal government’s COVID-19 vaccine allocation plan could create access issues for underserved communities and older populations, and he urged officials to focus on mitigating any potential disruptions, including weighing how to help states set up mobile vaccination sites.

October 28, 2020 | Daily News

FDA has indicated that it might not conduct pre-approval inspections of sites that are manufacturing COVID-19 vaccines and that are being considered for emergency use authorization, but there’s a lack of clarity about the agency’s alternative approaches to site inspections.

October 28, 2020 | Daily News

A leading pharmacy compounding group predicts that FDA might face lawsuits from states and compounding pharmacies over its final memorandum of understanding, which subjects compounding pharmacies located in states that don’t sign the MOU to a 5% sales cap on the amount of compounded product that can be shipped out-of-state.

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