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Rx Drugs

February 19, 2019 | Daily News

In a win for generic drug makers, the Supreme Court on Tuesday (Feb. 19) left in place a lower court ruling that struck a Maryland law against generic drug price gouging.

February 15, 2019 | Daily News

Hospitals that sued CMS over cuts to reimbursement for 340B drugs are asking the court to make CMS recalculate payments to make up for those cuts, but the government says that would require all hospital outpatient payments be recalculated in order to keep the pay system budget neutral and tells the court to let CMS figure out how to fix the situation.

February 15, 2019 | Daily News

Hospitals are asking a federal court to give CMS 30 days to scrap its plans to continue lower reimbursement for 340B drugs in 2019, as the court already found the 2018 pay cuts beyond the scope of the agency’s authority.

February 15, 2019 | Daily News

CMS will require hospitals that administer the expensive new CAR-T gene therapy to participate in a clinical registry or study aimed at determining whether real-world results mirror those from clinical trials used to get the treatments approved, according to a national coverage determination published Friday (Feb. 15) for chimeric antigen receptor (CAR) T-cells therapy.

February 15, 2019 | Daily News

House Ways & Means Chairman Rep. Richard Neal (D-MA) said Tuesday (Feb. 12) that he asked HHS Secretary Alex Azar to consider making prescription drug makers pay rebates to Medicare if they hike Part B drug prices faster than the rate of inflation.

February 15, 2019 | Daily News

FDA on Friday (Feb. 15) finalized a compounding rule that, for the first time, places six bulk drug substances on the list of bulk substances that can be used by compounders not registered as outsourcing facilities -- also known as the 503A bulks list.

February 15, 2019 | Daily News

FDA took another step toward encouraging more generic drug development by unveiling draft guidance on Friday (Feb. 15) that explains how drug developers can apply for the competitive generic therapy pathway, which is intended for generic versions of drugs that have little-to-no competition on the market.

February 14, 2019 | Daily News

FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package to be voted on Thursday (Feb. 14) to avert another shutdown.

February 14, 2019 | Daily News

FDA stakeholders are applauding the $269 million increase in FDA funding included in a government spending package passed by Congress Thursday (Feb. 14) to avert another shutdown.

February 14, 2019 | Daily News

A bipartisan group of House Energy & Commerce Committee leaders asked to meet with FDA Commissioner Scott Gottlieb to discuss challenges the agency faces in inspecting foreign drug manufacturing facilities.

February 13, 2019 | Daily News

In an in-person meeting, Senate Finance Committee Democrats on Wednesday (Feb. 13) asked HHS Secretary Alex Azar how the administration plans to eliminate Medicare Part D rebates without letting drug makers pocket that money instead of sharing it with seniors, according to a Democratic committee aide.

February 13, 2019 | Daily News

FDA released a draft guidance on Wednesday (Feb. 13) that calls for drug industry stakeholders and agency staff to draft a set of pharmaceutical quality consensus standards that potentially could be recognized by the agency.

February 13, 2019 | Daily News

HHS Secretary Alex Azar is scheduled to visit Democrats on the Senate Finance Committee Wednesday (Feb. 13) after holding a similar meeting a month ago with committee Republicans, according to a source familiar with the meeting.

February 13, 2019 | Daily News

Two FDA advisory committees on Tuesday (Feb. 12) recommended FDA approve Janssen’s esketamine intranasal spray to treat treatment-resistant depression, which some advisers called a “game changer” for those with TRD.

February 13, 2019 | Daily News

A coalition of organizations focused on health care, public health and safety, drug diversion prevention, and drug abuse prevention and treatment, and a former congresswoman, wrote to FDA Commissioner Scott Gottlieb urging the agency to embrace innovative, at-home systems for disposal of drugs when it implements wide-ranging legislation passed last year as part of congressional efforts to curb the opioid crisis.

February 12, 2019 | Daily News

A key liberal House Democrat said he is open to more moderate approaches to Medicare price negotiation than his own, but House Republicans oppose Medicare negotiation, especially if the plan were to let the government exclude coverage of drugs.

February 12, 2019 | Daily News

This week is the deadline for CMS to say how Medicare will pay hospitals for expensive CAR-T cancer treatments, and that first-of-its-kind national coverage decision will set a precedent that likely spills over into the commercial market.

February 11, 2019 | Daily News

Two FDA advisory panels on Tuesday (Feb. 12) will discuss the safety and efficacy of a novel esketamine drug-device combination intended to treat treatment-resistant depression (TRD), with the proposed treatment marking the first antidepressant product for which a randomized withdrawal trial was used to help show efficacy.

February 08, 2019 | Daily News

Capping out-of-pocket Part D costs is a priority for the administration, but HHS Secretary Alex Azar told patient advocates that lowering drug list prices comes first, according to sources familiar with the conversations.

February 08, 2019 | Daily News

Sen. Sherrod Brown (D-OH) and House Democrats are pushing sister bills to curb rising drug prices: one would direct Medicare to negotiate drug prices and let the government force generic competition before patents and exclusivities expire when negotiations fail; the other would penalize companies that price gouge.

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