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Rx Drugs

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.

November 26, 2018 | Daily News

FDA Commissioner Scott Gottlieb called low prices and CMS reimbursement for generic prescription drugs a “root cause” of drug shortages in a blog post he co-authored with the agency’s drug center chief, Janet Woodcock, last week.

November 21, 2018 | Daily News

Oklahoma and CMS officials are scheduled to talk this week about whether the scope of the state’s Medicaid agreement allows for drug reimbursement over time, according to Becky Pasternik-Ikard, chief executive officer of Oklahoma's Medicaid agency.

November 21, 2018 | Daily News

As pharmacy and other health care stakeholders convened last week to discuss myriad issues surrounding illegal online sales of prescription drugs, one FDA official called for companies that manage and sell internet domain names to ramp up enforcement of their terms of use agreements and stop allowing violative website operators to continue leasing domains under different website names. This, the official said, would help fix the whack-a-mole issue on FDA’s side of enforcement.

November 21, 2018 | Daily News

One industry lawyer found that FDA has put out many more new rules for the food and medical device industries over the past six years than it has for other industries, such as drugs, biologics, cosmetics and animal feed.

November 20, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Monday (Nov. 19) introduced a new risk-based framework for how the agency will regulate software products that are designed to be used in conjunction with prescription drugs, also known as prescription drug-use-related software.

November 20, 2018 | Daily News

Sen. Bernard Sanders (I-VT) and Rep. Ro Khanna (D-CA) on Tuesday (Nov. 20) unveiled a prescription drug-pricing bill that blends Republican and Democratic proposals: The legislative plan would expand the Trump administration’s international reference pricing concept to span the entire U.S. drug market and includes a Democratic proposal to give the government power to invalidate brand-drug makers’ exclusivity if their drug prices are deemed excessively high.

November 20, 2018 | Daily News

FDA is proposing to try out a minimally invasive dog drug study that the agency hopes will encourage industry to pursue similar studies, or ones that do not involve live dogs at all.

November 19, 2018 | Daily News

Some lawmakers and congressional staff don’t expect a big legislative push for 340B reform in the next Congress, but Rep. Buddy Carter (R-GA) says he is optimistic his legislation to boost the program’s transparency and reporting could gather bipartisan support.

November 19, 2018 | Daily News

Kaleo CEO Spencer Williamson offered to lower the $4,100 price of the opioid overdose reversal drug Evzio as long as insurers give patients greater access to it, during his appearance on CBS’ “60 Minutes” on Sunday.

November 19, 2018 | Daily News

FDA Commissioner Scott Gottlieb said the agency hopes to boost its use of real-world evidence and other tools to analyze drug performance and support new indications, and he announced FDA will issue a framework to evaluate the use of RWE.

November 16, 2018 | Daily News

Incoming Senate Finance Committee chairman Charles Grassley (R-IA) and Senate Democratic Whip Dick Durbin (D-IL) on Friday asked the Trump administration to put in place by year’s end its proposal to require drug manufacturers disclose list prices in direct-to-consumer advertising, and they also called on HHS and CMS to adopt additional drug-price disclosure measures.

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