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Rx Drugs

February 13, 2020 | Daily News

The Center for American Progress is recommending several policies to help states cut drug costs, but it is not enthusiastic about drug imports.

February 13, 2020 | Daily News

In March, FDA’s newly established Controlled Substances Program will launch its Opioid Data Warehouse, which will allow the agency to integrate diverse data sources and enhance data analysis to pinpoint trends and new developments in the opioid crisis, FDA Deputy Center Director for Regulatory Programs Doug Throckmorton said Wednesday (Feb. 12).

February 12, 2020 | Daily News

If the coronavirus epidemic continues to spread in China, the United States will begin to see shortages of drugs and medical supplies, former FDA chief Scott Gottlieb warned lawmakers during a Senate Homeland Security and Governmental Affairs Committee roundtable meeting Wednesday (Feb. 12).

February 11, 2020 | Daily News

Senate Majority Leader Mitch McConnell (R-KY) threw cold water on the chances of the Senate agreeing on drug pricing legislation hours after Sen. Chuck Grassley (R-IA) said he is gathering GOP support for his bill (S. 2543), and Senate Minority Leader Chuck Schumer (D-NY) insisted that senators also get a chance to vote on House Democrats’ Medicare drug price negotiation plan if the Senate takes up drug pricing legislation.

February 11, 2020 | Daily News

A bipartisan group of senators on Tuesday (Feb. 11) introduced their version of a bill that aims to close an Orphan Drug Act loophole that some experts allege allows drug makers to obtain orphan drug designation, and the corresponding seven years of exclusivity, if they claim they’re unable to recover development costs on the drug.

February 11, 2020 | Daily News

Senate Finance Chair Chuck Grassley said Tuesday (Feb. 11) he is updating his drug pricing bill to get more GOP support, but the Iowa Republican’s office said he is not axing the inflationary rebates that most Republicans oppose.

February 10, 2020 | Daily News

The president’s 2021 budget proposal assumes drug pricing legislation would save $135 billion -- a similar amount to the estimated savings from the Senate Finance Committee’s drug pricing bill -- but the budget does not endorse the Senate bill, an administration official said.

February 07, 2020 | Daily News

FDA Commissioner Stephen Hahn on Friday (Feb. 7) told a group of reporters that the agency is currently not aware of any disruption to the medical supply chain in China that could be caused by the coronavirus outbreak.

February 06, 2020 | Daily News

In a draft guidance published Thursday (Feb. 6), FDA says it hopes to nearly cut in half the amount of time it takes to review and act on biosimilar application supplements that seek approval for additional indications beyond those currently licensed.

February 06, 2020 | Daily News

The biosimilars industry and FDA will grapple with myriad regulatory shifts in 2020, with one of the most immediate challenges being the drug-to-biologic transition that some brand and generic drug makers will face next month.

February 05, 2020 | Daily News

The Bipartisan Policy Center is floating what it touts as a consensus, middle-of-the-road health reform plan aimed at lowering costs and stabilizing the market by building on the current system instead of repealing the health law or replacing it with a single-payer system.

February 05, 2020 | Daily News

FDA on Tuesday (Feb. 4) told Pfizer it had partially granted its 2018 citizen petition in which the company requested the agency publish guidance to ensure truthful and non-misleading communications about reference biologics and biosimilars.

February 05, 2020 | Daily News

Lawmakers and experts are pushing for reforms to stop alleged gaming of the Orphan Drug Act’s cost recovery pathway, which is designed to let drug makers obtain an orphan drug designation if they show they won’t recover their development costs.

February 05, 2020 | Daily News

The president on Tuesday (Feb. 4) gave a nod to Senate Finance Committee Chair Chuck Grassley (R-IA) and his drug pricing bill, but it’s unclear whether that mention during the State of the Union address was strong enough to convince Senate Republicans to back the bill.

February 04, 2020 | Daily News

FDA granted emergency use authorization to the first diagnostic test to detect novel coronavirus, the agency announced Tuesday (Feb. 4).

February 04, 2020 | Daily News

Former FDA Commissioner Scott Gottlieb criticized the Senate Finance Committee drug pricing bill’s inflationary rebate policy, arguing that patients who pay a drug’s full list price or those whose drug costs are tied to the list price will pay more if Congress imposes inflation caps on drug prices.

February 04, 2020 | Daily News

The Trump administration is criticizing drug pricing policies in the Netherlands, even though the Netherlands is among the countries President Donald Trump plans to rely on for setting Medicare drug prices.

February 04, 2020 | Daily News

CMS is developing a demonstration to make insulin affordable by offering Part D plans that provide extra help to seniors during the coverage gap phase of the program, possibly by capping their monthly costs, sources familiar with the initiative say.

February 03, 2020 | Daily News

FDA published a draft guidance on Monday (Feb. 3) that aims to curb misleading promotional labeling and advertisements for reference biologics or biosimilars by clarifying what should be considered when comparing reference products and biosimilars in promotional materials, and when it’s appropriate to present data from studies that aren’t included in the FDA-approved labeling.

February 03, 2020 | Daily News

FDA and the Federal Trade Commission are joining forces to advance biosimilars adoption, discourage false or misleading communications about biosimilars, and deter anticompetitive behaviors, the agencies announced in a joint statement Monday (Feb. 3).

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