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Rx Drugs

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.

January 14, 2021 | Daily News

Drug makers hiked net prices on seven drugs, without clinical evidence to support their higher prices, that cost taxpayers an additional $1.2 B in 2019, according to the Institute for Clinical and Economic Review.

January 13, 2021 | Daily News

Drug makers Eli Lilly, Sanofi and AstraZeneca sued HHS over its general counsel advisory opinion that says drug manufacturers are required to provide 340B discounts to providers in the program via contract pharmacies, with two of the drug makers stating the advisory opinion, if allowed to stand, would doom any administrative disputes over contract pharmacy restrictions.

January 13, 2021 | Daily News

Incoming Senate Finance Committee Chair Ron Wyden (D-OR) on Wednesday (Jan. 13) made clear that health care reforms, particularly reining in drug costs, will be a high priority but also warned the budget reconciliation process Democrats are expected to pursue could be a difficult path.

January 13, 2021 | Daily News

U.S. District Judge Dan Aaron Polster will allow plaintiffs in the national multi-district opioid litigation to obtain and preserve former FDA chief David Kessler’s expert testimony so that it can be used at future trials if he is again named FDA commissioner or takes on another official role under the Biden administration that could prevent him from testifying as an expert witness in the case.

January 12, 2021 | Daily News

The U.S. government will release supplies of Pfizer’s and Moderna’s COVID-19 vaccines that so far have been held back in reserve, HHS Secretary Alex Azar and Operation Warp Speed officials announced Tuesday (Jan. 12), coming just four days after Azar blasted President-elect Joe Biden’s plan to release the reserve supply as unethical and inconsistent with science and data, due to supply issues.

January 12, 2021 | Daily News

Pharmaceutical benefit managers sued the Trump administration Tuesday (Jan. 12) over a last-minute rule to end Medicare drug rebates that PBMs use to negotiate lower prices for insurers.

January 11, 2021 | Daily News

HHS Secretary Alex Azar criticized President-elect Joe Biden’s reported plan to quickly release the second doses of Pfizer’s and Moderna’s COVID-19 vaccines, which the Trump administration has held in reserve to ensure there are enough doses in stock to give everyone their second shot.

January 11, 2021 | Daily News

FDA Chief Stephen Hahn told reporters on Friday (Jan. 8) that the agency is working with the White House and industry to figure out how to increase availability of and speed up administration of COVID-19 vaccines, including by testing whether vaccines are effective at lower doses and considering novel clinical trial designs that would assess different vaccine dosing and administration methods.

January 11, 2021 | Daily News

FDA will not make non-traditional hand sanitizer manufacturers, such as breweries and distilleries that entered the market for COVID-19, pay over-the-counter monograph user fees, the agency’s drug center said in a Sunday (Jan. 10) email, citing HHS’ Federal Register notice that details the user fee exemption.

January 08, 2021 | Daily News

CMS for the first time will let a state exclude drugs from its Medicaid formulary and still keep automatic Medicaid rebates.

January 08, 2021 | Daily News

The American Hospital Association calls for the federal government to cut out “unnecessary confusion and complexity” around COVID-19 vaccine distribution and ramp up its communication and coordination with states, jurisdictions and other stakeholders to ensure the country can vaccinate at least 246 million people by May 31, which is the number of people required to achieve 75% herd immunity.

January 08, 2021 | Daily News

Sanofi, AstraZeneca and Novartis officials told Inside Health Policy their companies continue to restrict 340B discounts available through contract pharmacies, and Eli Lilly reportedly is continuing its restrictions as well, despite a recent HHS General Counsel advisory opinion asking the drug makers to scrap their policies and restore the discounts.

January 07, 2021 | Daily News

Eight Democratic governors want HHS Secretary Alex Azar and Operation Warp Speed Chief Operating Officer Gen. Gustave Perna to release the second doses of Pfizer’s COVID-19 vaccine, which federal officials have held back saying they would send them once it’s time to administer second doses to those who received the first dose.

January 07, 2021 | Daily News

A pharmaceutical prescribing expert tells Inside Health Policy that FDA ignored its own data when it warned earlier this week that allowing patients to go longer than the authorized three to four weeks between COVID-19 vaccine inoculations is not supported by current scientific evidence.

January 06, 2021 | Daily News

HHS late Tuesday evening (Jan. 5) indicated it planned to exempt distilleries and other small businesses that supplied hand sanitizer during the COVID-19 public health emergency from FDA’s over-the-counter monograph user fee program.

January 06, 2021 | Daily News

Democratic control of the Senate sets up a debate between the liberal and moderate wings of the party over how to curb drug prices, but the bigger obstacle to drug pricing legislation could be a Republican filibuster, unless Democrats pay for Bidencare policies with drug pricing measures in budget-neutral legislation that they could pass with a simple majority using a budget process called budget reconciliation.

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