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Rx Drugs

December 06, 2018 | Daily News

Through its new real-world evidence framework, FDA will evaluate how RWE can be used to support changes to labeling about a drug or biologic product’s effectiveness.

December 06, 2018 | Daily News

Spending on health care grew at a slower rate in 2017 than in 2016 in part because Medicaid spending slowed due to the lull in Medicaid expansions and drug spending growth slacked off following the spike in spending to treat hepatitis C, according to the CMS actuary’s office.

December 06, 2018 | Daily News

The Supreme Court heard oral arguments Tuesday (Dec. 4) in a case that pits brands versus generics over whether secret sales of drugs trigger the one-year countdown to file a patent.

December 06, 2018 | Daily News

The Federal Trade Commission says it stands ready to help FDA thwart citizen petition abuses aimed at delaying generic and biosimilar competition, but FTC’s comments to FDA offer no insights into how the antitrust enforcer would improve upon its past, limited performance in curtailing citizen petition abuses.

December 05, 2018 | Daily News

The American Hospital Association and a wide range of health care stakeholders urged congressional leaders to pass a key health security bill before the end of the lame-duck session, arguing that, without reauthorization from lawmakers, essential HHS emergency preparedness authorities will expire and gaps in federal response programs will remain unfilled.

December 05, 2018 | Daily News

The incoming Senate Finance Committee chair and ranking Democrat introduced Tuesday (Dec. 4) a bill to recoup Medicaid rebates from drug companies that misclassify drugs.

December 05, 2018 | Daily News

The incoming Senate Finance Committee chair and ranking Democrat introduced Tuesday (Dec. 4) a bill to recoup Medicaid rebates from drug companies that misclassify drugs.

December 05, 2018 | Daily News

The Institute for Clinical Economic Review (ICER) on Monday (Dec. 3) issued a final report featuring recommendations for how to develop policy on and increase access to extended-release medications for addiction treatment.

December 03, 2018 | Daily News

The administration criticized state laws that open up restricted pharmacy networks, because administration officials believe those laws make it difficult for plans and pharmacy benefit managers to negotiate discounts from providers, which increases costs to consumers.

December 03, 2018 | Daily News

In a further bid to streamline generic drug development, FDA on Monday (Dec. 3) clarified the procedures for generic drug makers to request meetings with the agency after receiving complete response letters (CRL) indicating deficiencies in their applications.

December 03, 2018 | Daily News

Sen. Bill Cassidy (R-LA) told Inside Health Policy that he is in the early stages of developing a bill that would address payment models for high-cost prescription drugs such as gene therapies.

November 30, 2018 | Daily News

In advance of World AIDS Day on Dec. 1, FDA announced a pilot program with the World Health Organization (WHO) that would provide WHO with FDA reviews of new HIV drug applications, thereby allowing WHO to make regulatory decisions about the new drugs faster and to share their decisions with regulators in developing countries with HIV-affected patient populations, FDA writes.

November 30, 2018 | Daily News

AbbVie announced Friday (Nov. 30) that it has reached an agreement to delay the launch of Pfizer’s biosimilar referencing the blockbuster arthritis drug Humira.

November 29, 2018 | Daily News

Incoming Senate Finance Chair Chuck Grassley outlined his agenda for lowering drug prices in a floor speech Thursday (Nov. 29) that included praise for actions taken by the Trump administration but made no mention of HHS’ controversial proposal to base Medicare Part B reimbursement on drug prices set by foreign governments.

November 29, 2018 | Daily News

The Health Resources and Services Administration quickly finalized a regulation to push up implementation of the 340B ceiling price and penalties rule to Jan. 1, saying the action will not interfere with HHS’ overall drug-pricing strategy and HRSA can continue with additional 340B rulemaking after the ceiling price and penalties regulation has been implemented.

November 28, 2018 | Daily News

The White House Office of Management and Budget on Tuesday (Nov. 27) began reviewing a final regulation that, as proposed, would move up implementation of the 340B ceiling price and penalties rule to Jan. 1.

November 27, 2018 | Daily News

Drug pricing is one of the only areas where the two parties and the president might find common ground to make laws, and President Donald Trump, Democrats and incoming Senate Finance chair have been harping on drug prices so long that it will be difficult for them to do nothing, according to two former White House health aides for Republican and Democratic administrations.

November 27, 2018 | Daily News

The International Consortium of Harmonisation agreed with FDA Commissioner Scott Gottlieb this month that its members should develop standard international approval requirements for generic drugs, which would facilitate simultaneous approvals in multiple markets.

November 27, 2018 | Daily News

Continuing drug shortage issues are a result of economic and policy failures that span many years, FDA Commissioner Scott Gottlieb told a crowd of researchers, health care providers, industry representatives and other experts during the agency’s Tuesday (Nov. 27) drug shortages public meeting, held in coordination with the Duke Margolis Center for Health Policy.

November 26, 2018 | Daily News

MS proposed Monday (Nov. 26) letting Part D plans exclude drugs in protected classes from Part D formularies when their makers raise prices faster than inflation or when drug companies make new formulations of drugs already on the market.

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