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Rx Drugs

November 11, 2019 | Daily News

White House Domestic Policy Council Director Joe Grogan is not a fan of including drug rebate reform in the Senate’s drug pricing bill, and he would rather spend what little time is left tweaking policies that ensure the bill doesn’t raise premiums and that spread more of the bill’s Part D savings to more seniors.

November 11, 2019 | Daily News

FDA is laying the groundwork to study how the general public interprets drug promotion.

November 08, 2019 | Daily News

White House Domestic Policy Advisor Joe Grogan suggested that lawmakers are close to an agreement on surprise billing legislation and believes that something will pass either stand alone or attached to drug pricing measures by the end of the year.

November 07, 2019 | Daily News

Dozens of hospital and pharmacy groups have thrown their support behind a bipartisan Senate bill to avert drug shortages, with sources telling Inside Health Policy some of the groups worked with the cosponsors to develop the bill.

November 07, 2019 | Daily News

Humira revenues fell 33.5% internationally in the third quarter of this year due to biosimilar competition, according to AbbVie, while revenues increased 9.6% in the United States, where there is no biosimilar competition until 2023.

November 07, 2019 | Daily News

Sen. Dick Durbin (D-IL) said Wednesday (Nov. 6) he will soon request a floor vote on legislation to require that television drug advertisements disclose list prices.

November 07, 2019 | Daily News

HHS has sued Gilead for patent infringement after the drug manufacturer repeatedly refused to obtain licenses for HHS patents on an HIV medication. The suit, filed in federal court in Delaware, alleges Gilead willfully infringed on patents given to HHS meant to protect the government’s work in developing pre-exposure prophylaxis (PrEP), and has profited from research funded by taxpayers through the sale of the brand-name drugs Truvada and Descovy, according to HHS.

November 06, 2019 | Daily News

Senate Homeland Security and Governmental Affairs Committee ranking Democrat Sen. Gary Peters (MI) on Tuesday (Nov. 5) launched an investigation to identify solutions to high drug prices and drug shortages, which he said raise serious health, economic and national security threats.

November 06, 2019 | Daily News

Senate Finance Committee Chair Chuck Grassley suggested  Tuesday (Nov. 5) that he plans to file an updated drug pricing bill next week, and a White House official said the administration is working with the Iowa Republican and ranking Finance Democrat Ron Wyden (OR) on provisions to limit seniors’ monthly out-of-pocket costs and to help seniors with sharply rising insulin list prices.

November 06, 2019 | Daily News

FDA will start picking leaders for newly formed review divisions as part of the second phase of its reorganization of the Office of New Drugs, the agency announced Wednesday (Nov. 6).

November 01, 2019 | Daily News

The White House Office of Management and Budget is reviewing the controversial price transparency provisions in CMS’ proposed 2020 outpatient pay rule separately from the rest of the rule, according to the OMB website.

October 31, 2019 | Daily News

The Senate health committee on Thursday (Oct. 31) cleared for a floor vote legislation that would reform FDA’s regulation of over-the-counter drugs, including by setting up a user fee program and providing 18 months of exclusivity for innovative OTC drug products, as proposed by the House.

October 31, 2019 | Daily News

FDA needs new authority from Congress to monitor, in real time, information about facilities that produce active pharmaceutical ingredients, FDA drug center director Janet Woodcock told lawmakers during a House Energy & Commerce health subcommittee hearing Wednesday (Oct. 30).

October 31, 2019 | Daily News

A bipartisan Senate bill introduced Tuesday (Oct. 29) would require that FDA speed facility inspections and application reviews for generic drugs in short supply, make bulk drug manufacturers disclose supply disruptions, and direct makers of life-supporting drugs to develop back up manufacturing plans and tell FDA where drugs are made.

October 30, 2019 | Daily News

The White House opposes House Speaker Nancy Pelosi’s (D-CA) government drug price negotiation bill, Domestic Policy Council chief Joe Grogan told Politico on Wednesday (Oct. 30).

October 30, 2019 | Daily News

The White House sees little chance for enactment of House Speaker Nancy Pelosi’s (D-CA) government drug price negotiation bill and is pushing for passage of the Senate Finance Committee's bill, Domestic Policy Council chief Joe Grogan told Politico on Wednesday (Oct. 30).

October 30, 2019 | Daily News

During a House Energy & Commerce health subcommittee hearing on Wednesday (Oct. 30), FDA drug center director Janet Woodcock urged Congress to address loopholes in the agency’s authority that allow some active pharmaceutical ingredient suppliers and foreign finished product manufacturers to bypass facility registration and inspection requirements while still being able to ship and sell finished drug products in the United States.

October 29, 2019 | Daily News

In its highly anticipated drug shortages report published Tuesday (Oct. 29), FDA says drug makers need more financial incentives to produce older, less profitable drugs, and they need to be rewarded and recognized for implementing mature quality management systems in their manufacturing processes.

October 29, 2019 | Daily News

The House on Monday (Oct. 28) unanimously passed legislation that would require HHS to publish pharmacy benefit managers’ aggregate rebates, discounts and price concessions and require plans to include real-time benefit information on drug costs in Medicare Part D.

October 29, 2019 | Daily News

The House will vote on its government drug-price negotiation bill soon after returning from next week’s recess, Majority Leader Steny Hoyer (D-MD) said.

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