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Rx Drugs

August 28, 2020 | Daily News

The National Institutes of Health will study an alternative to remdesivir that could save the government money because the patents for the drug are older than those for remdesivir, according to Public Citizen, which requested the NIH research.

August 28, 2020 | Daily News

President Donald Trump touted his administration’s COVID-19 response and again suggested a vaccine could be available sooner than the end of the year, as he accepted the Republican presidential nomination late Thursday evening (Aug. 27).

August 27, 2020 | Daily News

Pharmacists joined hospital groups to call on HHS Secretary Alex Azar to stop drug makers from conditioning discounts on 340B claims reports or limiting discounts for drugs purchased through contract pharmacies.

August 27, 2020 | Daily News

FDA will hold an advisory committee meeting on Oct. 22 to discuss general COVID-19 vaccine development and emergency use authorization or licensure policies, the agency announced in a Thursday (Aug. 27) Federal Register notice.

August 26, 2020 | Daily News

In a Wednesday (Aug. 26) journal article, Operation Warp Speed head Moncef Slaoui and vaccines project lead Matthew Hepburn reiterate their hopes of getting a COVID-19 vaccine developed and ready to be deployed by early 2021.

August 26, 2020 | Daily News

FDA chief Stephen Hahn has not responded to Senate Republicans’ requests for more information on why the agency decided to revoke emergency use authorization for hydroxychloroquine and chloroquine in June, and then to subsequently reject Henry Ford Health System’s request to reissue the authorization.

August 26, 2020 | Daily News

The generic drug lobby has refiled its suit challenging a California law that bans so-called pay-for-delay settlements after a U.S. district court Tuesday (Aug. 25) dismissed the case saying generic drug makers failed to prove they would be financially harmed by the law. AAM tells Inside Health Policy it has refiled the case with additional evidence.

August 26, 2020 | Daily News

Brand drug makers are offering two alternatives to the president’s most-favored-nation executive order: one would hurt doctors and hospitals, instead of drug makers, and the other is loosely based on the Senate Finance Committee drug pricing bill, according to a summary of the proposals obtained by Inside Drug Pricing.

August 25, 2020 | Daily News

The Association for Accessible Medicines has named National Pharmaceutical Council head Dan Leonard to be its new president and CEO, the generic drug lobby announced Tuesday (Aug. 25).

August 25, 2020 | Daily News

HHS Secretary Alex Azar is letting pharmacists temporarily administer vaccines to children during the pandemic, and hospital pharmacists want Azar to use the same authority he relied on for that directive to let pharmacists administer coronavirus vaccines to adults and children once they are available.

August 25, 2020 | Daily News

The White House has tapped Heartland Institute health care expert David Gortler to be senior advisor to FDA chief Stephen Hahn, bringing in a former FDA medical officer who has criticized the agency for making approval decisions based on little evidence and has advocated a new drug review regime that looks at drug pricing.

August 25, 2020 | Daily News

FDA chief Stephen Hahn walked back statements that convalescent plasma could save 35% of COVID-19 patients, after public health experts blasted him for mischaracterizing the data and misleading the public at a recent White House press briefing.

August 24, 2020 | Daily News

Key House Energy & Commerce Committee Democrats wrote to FDA chief Stephen Hahn Monday (Aug. 24) raising concerns President Donald Trump and the White House have stepped up political pressure on the agency and asking how Hahn is protecting the agency’s credibility.

August 23, 2020 |

The president tweeted Saturday night (Aug. 22) that he signed last week the executive order to base Medicare reimbursement on the lowest drug prices among developed countries — an order he earlier said he would hold off signing if the drug industry presented an acceptable alternative by Monday (Aug. 24).

August 23, 2020 | Daily News

The president tweeted Saturday night (Aug. 22) that he signed last week the executive order to base Medicare reimbursement on the lowest drug prices among developed countries — an order he earlier said he would hold off signing if the drug industry presented an acceptable alternative by Monday (Aug. 24).

August 21, 2020 | Daily News

With a Monday deadline looming, the drug industry does not seem to have agreed on a policy to present to the White House as an alternative to the president’s plan to base Medicare reimbursement on the cheapest prices for drugs in other developed countries.

August 21, 2020 | Daily News

Phoenix Biotechnology, the company behind the controversial push to use the botanical extract oleandrin as a COVID-19 cure, tells Inside Health Policy the company is pursuing a “multitude of different angles” at FDA to bring the product to market, coming as President Donald Trump touts the botanical but leading scientific experts cast doubt on its effectiveness as a COVID-19 treatment and cite potential health risks.

August 21, 2020 | Daily News

The American Hospital Association on Friday (Aug. 21) told Novartis, AstraZeneca, Lilly, Merck and Sanofi their plans to stop 340B discounts on drugs obtained through contract pharmacies or require data submissions before such discounts can be accessed “violate statutory, administrative and ethical guidelines and principles,” and said the drug makers need to stop.

August 20, 2020 | Daily News

The Health Resources and Services Administration tells Inside Health Policy that drug makers that curb 340B discounts at contract pharmacies might prevent vulnerable people from getting affordable drugs and the agency is encouraging drug makers to continue the discounts -- but it cautions the agency can only take enforcement action if there is a violation of the statute.

August 19, 2020 | Daily News

FDA last week put on hold plans to issue an emergency use authorization for donated convalescent plasma to treat COVID-19 after National Institutes of Health Director Francis Collins, National Institute of Allergy and Infectious Diseases Director Anthony Fauci and other top health officials argued the emerging data were too weak, the New York Times reported Wednesday (Aug. 19) morning, citing two senior administration officials.

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