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Rx Drugs

September 24, 2020 | Daily News

The Trump administration on Thursday (Sept. 24) finalized a rule laying out steps for states to create programs to import certain prescription drugs from Canada and separately put out guidance on how drug makers could import both drugs and biologic products, such as insulin.

September 24, 2020 | Daily News

Senate health committee ranking Democrat Patty Murray (WA) said the president’s expected nomination Saturday of a conservative Supreme Court judge could lead to the Affordable Care Act being overturned, which she said would pour “rocket fuel” on the ongoing pandemic and eliminate a requirement that health insurers cover vaccines without cost-sharing.

September 24, 2020 | Daily News

Drug industry executives are scheduled to testify on drug pricing practices over two days at a House Oversight Committee hearing next week, following an 18-month committee probe into price increases, executive compensation and patent strategies.

September 24, 2020 | Daily News

The nonprofit generic drug maker Civica Rx says the U.S. government could curb drug shortages by funding new U.S. manufacturing processes, giving drug makers tax credits to make drugs and ingredients domestically, creating a list of critical drugs with production targets, and setting up a privately run drug stockpile.

September 23, 2020 | Daily News

President Donald Trump on Wednesday evening (Sept. 23) asserted that FDA’s reported efforts to develop stricter emergency use authorization criteria for COVID-19 vaccines seems like a political move, and he said the White House will review any criteria the agency develops.

September 23, 2020 | Daily News

President Donald Trump on Wednesday evening (Sept. 23) asserted that FDA’s reported efforts to develop stricter emergency use authorization criteria for COVID-19 vaccines seems like a political move, and he said the White House will review any criteria the agency develops.

September 23, 2020 | Daily News

Sen. Elizabeth Warren (D-MA) called for Operation Warp Speed chief Moncef Slaoui to resign or be fired from that position, a day after the House select subcommittee on the coronavirus released financial documents that the subcommittee said raise questions about Slaoui’s investments in GlaxoSmithKline, which is working to develop a COVID-19 vaccine under the government’s initiative.

September 23, 2020 | Daily News

The House Energy & Commerce oversight subcommittee will hold a hearing on Sept. 30 to hear from scientists and public health experts on what criteria they think COVID-19 vaccines should be required to meet before being approved or authorized by FDA for distribution in the United States, the subcommittee announced Wednesday (Sept. 23).

September 23, 2020 | Daily News

The Health Resources and Services Administration on Monday (Sept. 21) told Eli Lilly and Company that it shouldn’t assume HHS agrees with its decision to end 340B pricing for drugs obtained through most contract pharmacies, and warned the drug maker it could face a lawsuit if HRSA finds the company “knowingly violates a material condition of the program that results in over-charges to grantees and contractors.”

September 22, 2020 | Daily News

Public health and clinical trial experts say the clinical trial protocols released by three leading COVID-19 vaccine makers are on par with standard trial protocols, but one expert wonders whether the companies will be able to meet FDA’s requirements for safety data if trials are stopped early or the agency grants emergency use authorization before the trials are finished.

September 22, 2020 | Daily News

The House again passed two bipartisan bills that aim to give FDA authority to destroy counterfeit medical devices and that direct the agency to establish centers of excellence focused on continuous manufacturing.

September 21, 2020 | Daily News

HHS on Sunday evening (Sept. 20) defended a new internal policy that requires HHS Secretary Alex Azar to formally sign off on any health agency rules, including those from FDA, saying that it’s intended to minimize litigation risks.

September 17, 2020 | Daily News

In a letter sent to FDA Thursday (Sept. 17), more than 90 organizations, led by the Infectious Diseases Society of America, urged agency officials to ensure the review process for any potential COVID-19 vaccine candidate will be transparent and adhere to high regulatory standards.

September 17, 2020 | Daily News

Pressure on HHS to stop drug makers from undermining the role of contract pharmacies in the 340B drug discount program is growing after a bipartisan group of 28 senators on Thursday (Sept. 17) added to the dozens of House lawmakers also calling on HHS Secretary Alex Azar to do something about the actions of a handful of drug companies before their tactics spread.

September 17, 2020 | Daily News

Amid increased calls from experts and former HHS officials for COVID-19 vaccine developers to publicize the protocols they are using to determine when to start and stop clinical trials, vaccine manufacturer Moderna became the first to publish its clinical trial protocols Thursday (Sept. 17).

September 17, 2020 | Daily News

Pfizer hopes to develop a second-generation coronavirus vaccine that is fridge-stable and can be delivered in a single dose, Pfizer Senior Vice President and Head of Vaccine Research and Development Kathrin Jansen said Tuesday (Sept. 15).

September 17, 2020 | Daily News

Drug importation is likely to advance regardless of the election’s outcome, but the future of price-inflation caps and international reference pricing is uncertain and Medicare price negotiation will not happen unless Democrats win the White House and both chambers of Congress, according to the Biotechnology Industry Organization.

September 17, 2020 | Daily News

Mail deliveries of prescription drugs are running on average about a day later than usual due to actions by U.S. Postmaster General Louis DeJoy, according to a report released Wednesday (Sept. 9) by Democratic Sens. Elizabeth Warren (MA) and Bob Casey (PA).

September 16, 2020 | Daily News

The American Hospital Association, Association of American Medical Colleges and America’s Essential Hospitals asked the full U.S. Court of Appeals for the District of Columbia Circuit to rehear their lawsuit over cuts to hospitals’ Medicare reimbursement for 340B drugs, arguing the court’s initial decision doesn’t match up with previous court rulings and doesn’t take into account the exceptional importance of the issue at hand.

September 16, 2020 | Daily News

A group of Democratic senators and Sen. Bernie Sanders (I-VT) asks the Pharmaceutical Research and Manufacturers of America in a Sept. 15 letter what it is doing to stop what they allege are likely illegal moves by drug makers to limit 340B discounts obtained through contract pharmacies as well as requests for claims data from those pharmacies, coming as Sen. Joe Manchin (D-WV) hikes pressure on HHS Secretary Alex Azar to step in with his own Sept. 15 letter.

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