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Rx Drugs

January 18, 2019 | Daily News

CMS proposed Friday (Jan. 18) to share with insurers savings from lower Part D catastrophic spending in return for plans agreeing to penalties when they exceed spending targets.

January 17, 2019 | Daily News

Three years after publishing a draft guidance on rare disease drug development, FDA on Wednesday (Jan. 16) released a revised version of the guidance that agency commissioner Scott Gottlieb said will “provide additional advice to innovators on how they can pursue more efficient, effective development programs.”

January 16, 2019 | Daily News

In a new draft guidance released Wednesday (Jan. 16), FDA provides recommendations to generic drug makers on how to prepare and submit changes to their tentatively approved drug applications so they can receive final lawful approval on the earliest date possible based on patent and exclusivity protections.

January 16, 2019 | Daily News

Premier Inc. announced on Monday (Jan. 14) it has formed a company intended to help address drug shortages.

January 11, 2019 | Daily News

Senate Finance Committee Chairman Sen. Chuck Grassley (R-IA) will discuss a bill on pharmacy benefit manager transparency this session with his committee, a spokesman for the senator told Inside Health Policy.

January 11, 2019 | Daily News

The Senate has added to its list of active legislation the House-passed pandemic and emergency preparedness bill, which features language that would reform the way FDA regulates over-the-counter drugs and establish a user fee program for OTC products.

January 10, 2019 | Daily News

Democratic and independent lawmakers, including two potential contenders for the 2020 presidential nomination, called on President Donald Trump to support a package of three aggressive bills intended to lower prescription drug prices.

January 10, 2019 | Daily News

Newly tapped Senate Finance Chair Chuck Grassley (R-IA) said Wednesday (Jan. 9) he opposes Medicare drug price negotiation, but he seemed to imply he’s open to either changing or eliminating the risk corridors that help protect Part D drug plans from losing money.

January 10, 2019 | Daily News

Senate Finance Committee Chair Chuck Grassley (R-IA) said he is waiting to see what CMS formally proposes before passing judgment on the International Pricing Index demonstration, but he nevertheless opposes the most important aspect of the informal proposal: indexing U.S. drug prices to those set by foreign countries.

January 09, 2019 | Daily News

Over the next five years, FDA hopes to grow its electronic safety surveillance system, known as Sentinel, into a national data and scientific resource that functions as a multi-purpose center for evidence generation, FDA Commissioner Scott Gottlieb wrote in an FDA Voice blog on Wednesday (Jan. 9).

January 09, 2019 | Daily News

Incoming House Oversight & Reform Committee Chairman Rep. Elijah Cummings (D-MD) and Reps. Peter Welch (D-VT) and Joe Neguse (D-CO) will join original sponsors Sen. Bernard Sanders (I-VT) and Rep. Ro Khanna (D-CA) in supporting a bill that would expand the Trump administration’s international reference pricing concept to span the entire U.S. drug market and would give the government power to invalidate brand-drug makers’ exclusivity if their drug prices are deemed excessively high.

January 09, 2019 | Daily News

As one of his first actions as governor, California Gov. Gavin Newsom (D) ordered the state health department to consolidate purchasing power for prescription drugs under its Medicaid program.

January 09, 2019 | Daily News

FDA Commissioner Scott Gottlieb reiterated over the weekend (Jan. 5 and 6) that the agency will not accept any new abbreviated new drug applications for generic drugs during the government shutdown, and said that funding to review some pending brand-drug and biologic applications will run out in about a month.

January 08, 2019 | Daily News

The House late Tuesday (Jan. 8) passed, for the second time in the past month, a legislative package that would both reauthorize a number of hazard preparedness programs and reform the way FDA regulates over-the-counter (OTC) drugs.

January 08, 2019 | Daily News

FDA is setting up a new Office of Drug Evaluation Science (ODES) that will act as a centralized point of information for various performance metrics and provide more predictable and efficient assessment of safety data, FDA Commissioner Scott Gottlieb announced Tuesday (Jan. 8).

January 08, 2019 | Daily News

Hospitals have revamped their lawsuit over repeated delays of the 340B ceiling price and penalties rule to ask that the federal D.C. district court make the Health Resources and Services Administration publish 340B ceiling prices on an HHS website by April -- which the agency has said it expects to do.

January 08, 2019 | Daily News

Hospitals are urging the federal D.C. district court not to give the federal government extra time to say how the court should move forward following its ruling that CMS lacked authority to cut reimbursement for 340B drugs in the 2018 outpatient hospital rule.

January 08, 2019 | Daily News

The House will consider on Tuesday (Jan. 8) legislation that would reform FDA’s process for regulating over-the-counter drugs and would reauthorize a number of HHS hazard preparedness programs, according to House Majority Leader Rep. Steny Hoyer’s (D-MD) daily schedule for Tuesday.

January 07, 2019 | Daily News

The Supreme Court on Monday (Jan. 7) heard oral arguments on a drug labeling case over whether drug maker Merck Sharp & Dohme Corp. should be held liable for injury to consumers even after FDA rejected the company’s proposal to include on its drug label warnings about potential fractures that could be caused by the osteoporosis drug Fosamax.

January 07, 2019 | Daily News

Congressional Democrats set the stage for 2019 by raising the stakes on legislation to control drug prices, and Republicans also are pushing bills to rein in drug prices.

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