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Rx Drugs

January 06, 2021 | Daily News

President-elect Joe Biden’s promise to freeze Trump administration proposed rules could also delay a few drug-pricing rules that the Trump administration recently finished but that have not taken effect, and it would be much easier for Biden administration officials to overturn final rules if Democrats win back the Senate and invoke the Congressional Review Act.

January 05, 2021 | Daily News

FDA drug center director Janet Woodcock, who last May joined the Trump administration’s Operation Warp Speed initiative and recused herself from FDA’s COVID-19 product review decisions, will take on a new role at FDA -- principal medical adviser to FDA chief Stephen Hahn.

January 05, 2021 | Daily News

Industry lawyers say it is unclear how FDA will handle on-site facility inspections as the COVID-19 health emergency spills into 2021 and sponsors of COVID-19 vaccines and therapeutics that received emergency use authorization move toward full approvals.

January 04, 2021 | Daily News

FDA announced late Monday evening (Jan. 4) that changing the doses for authorized COVID-19 vaccines is not backed by scientific evidence and could pose health risks despite recent suggestions by a top Operation Warp Speed official that some of the vaccines could be safely administered in half-doses.

January 04, 2021 | Daily News

FDA forecasts plans in its latest unified agenda to propose seven new rules, none of which have been included in previous agendas.

January 04, 2021 | Daily News

The drug and device industries are pushing back against FDA’s plans to finalize a rule this month that will amend the definition of “intended use,” alleging the rule would violate the First and Fifth Amendments.

December 31, 2020 | Daily News

Pharmaceutical Research and Manufacturers of America says the Health Resources and Services Administration rushed the 340B administrative dispute resolution regulation without thinking through the consequences and the changes in the 340B landscape between 2016 and 2020, making it a faulty regulation.

December 31, 2020 | Daily News

Specialty drugs spending is on the rise, but the use of biosimilars could help lower overall costs, according to the Pharmaceuticals Strategy Group’s year-end report on drug costs.

December 30, 2020 | Daily News

The HHS Office of General Counsel on Wednesday (Dec. 30) said drug manufacturers are required to provide 340B discounts to providers in the program via contract pharmacies, stating in an advisory opinion that the method by which 340B providers dispense drugs doesn’t affect the drug makers’ obligation to provide discounts.

December 30, 2020 | Daily News

As other countries start planning human challenge trials to study and speed development of COVID-19 vaccines, debate continues in the United States over whether the controversial trial approach, in which participants are infected with the live virus, is ethical or necessary.

December 30, 2020 | Daily News

The National Coalition on Health Care is urging the Biden transition team to make controlling drug prices a priority and suggests the incoming administration let insurers band together as one to negotiate drug prices and use inflationary rebates to curb price inflation.

December 29, 2020 | Daily News

Medicare seems to have figured out how to make coronavirus antibody therapies free for everyone in Medicare after initially struggling to determine how to make the administration of antibody therapies free for Part B beneficiaries who lack supplemental coverage.

December 24, 2020 | Daily News

Operation Warp Speed chief Moncef Slaoui said he thinks vaccine makers should unblind their trials once they get emergency use authorization and let participants who received placebo move over to the active vaccine arm, no matter their risk group, a view that conflicts with FDA’s stance that vaccine makers should keep their trials blinded for as long as possible to obtain more robust safety and efficacy data.

December 23, 2020 | Daily News

The Trump administration managed to buy another 100 million doses of Pfizer’s coronavirus vaccine for about $2 billion after turning down the extra 100 million doses this summer, and as recently as this November, and finding itself in a bind because other countries bought those doses in the interim.

December 22, 2020 | Daily News

The Trump administration on Tuesday (Dec. 22) finished a rule that implements the Trump administration’s executive order requiring community health centers to pass 340b discounts for insulin and EpiPens to patients.

December 22, 2020 | Daily News

The U.S. government and Moderna are considering conducting dose sparing trials of the company’s COVID-19 vaccine to see if it could be just as effective at doses lower than the 100 micrograms for which it’s currently indicated, Operation Warp Speed chief Moncef Slaoui said during a press call Tuesday (Dec. 21).

December 22, 2020 | Daily News

CMS will delay for two years a policy of subtracting copay coupons and other patient financial assistance from prices used to determine how much Medicaid pays for drugs, according to the final Medicaid best price rule out Monday (Dec. 21).

December 22, 2020 | Daily News

Drug makers are largely unscathed by the year-end government spending bill because Congress instead used hospital surprise billing legislation to pay for coronavirus relief, but the legislative package does include proposals that were part of drug price transparency bills, including one to give congressional Medicare and Medicaid advisers data on closely guarded rebates.

December 22, 2020 | Daily News

Several insurers across the country have either not included cost-free coverage of PrEP as required or make it difficult for the enrollee to figure out how to get the coverage, according to an analysis by the HIV + HEP Policy Institute, which calls on regulators to enforce the law.

December 21, 2020 | Daily News

Federal Judge Catherine Blake said Friday she will rule by Dec. 24 on whether to put on hold the Trump administration’s plan to tie Medicare Part B reimbursement to foreign drug prices.

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