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Rx Drugs

June 06, 2018 | Daily News

CMS will announce as early as next week an agreement to lower the cash price of insulin for beneficiaries who choose to buy the drugs without their insurance, according to a source familiar with plan.

June 06, 2018 | Daily News

FDA is weighing how to further incentivize testing of previously approved mass-marketed drugs to treat rare diseases, despite the fact that a legislative proposal to do just that has been fiercely contested by drug pricing advocates.

June 06, 2018 | Daily News

In a change of tone for HHS, CMS on Tuesday (June 5) highlighted findings in the Medicare trustees annual report that showed spending growth has slowed in the Part D retail drug benefit.

June 05, 2018 | Daily News

Senate Democrats will use the month of August to work on legislation to lower health care costs, including drug prices, according to Minority Leader Charles Schumer (D-NY), who says that Majority Leader Mitch McConnell (R-KY) handed Democrats a "wonderful, great opportunity" with his decision to scrap the recess period that parties typically use to campaign for the mid-term elections.

June 05, 2018 | Daily News

The Senate health committee will hold a hearing on the 340B drug discount program with Health Resources and Services Administration personnel on June 19, the committee announced.

June 05, 2018 | Daily News

The Senate Judiciary Committee will begin marking up the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act Thursday (June 7), the committee announced Tuesday (June 5).

June 05, 2018 | Daily News

FDA sent warning letters to nine online networks operating 53 websites demanding they stop illegally marketing misbranded and unapproved drugs, specifically opioids, the agency announced Tuesday (June 5).

June 04, 2018 | Daily News

FDA announced Monday (June 4) evening approval of the first biosimilar to Neulasta (pegfilgrastim), which reduces the chance of infection for cancer patients undergoing chemotherapy.

June 04, 2018 | Daily News

Total Part D reimbursement for brand-name drugs increased 77 percent from 2011 to 2015, even though seniors filled 17 percent fewer prescriptions over the same period, according to the HHS Office of Inspector General.

June 04, 2018 | Daily News

FDA's evolving plan to significantly reorganize its Office of New Drugs includes centralizing project management functions across the agency's 19 review divisions, enhancing information technology capabilities, establishing a unified post-market safety surveillance framework, and focusing on multidisciplinary teams assigned to new drug applications, FDA Commissioner Scott Gottlieb and drug center Director Janet Woodcock announced Monday (June 4).

June 04, 2018 | Daily News

Senate appropriators are calling on FDA to develop a framework to add information about co-prescribing opioids with naloxone to opioid labels and Risk Evaluation and Mitigation Strategies information.

June 04, 2018 | Daily News

The administration would be wise to test drug price-cutting policies on ophthalmologists and rheumatologists before expanding demonstrations to cover more politically powerful cancer doctors, health care analysts say, though ophthalmologists and rheumatologists stress that they helped kill the Obama administration’s proposed Part B demo.

June 01, 2018 | Daily News

The Health Resources and Services Administration signaled Friday (June 1) that it plans to make additional changes to the 340B program -- including changes affecting providers.

June 01, 2018 | Daily News

The Health Resources and Services Administration is pushing back the effective date of 340B ceiling prices and penalties requirements until July 2019, according to a final rule released Friday (June 1) that again tied the delay to a need for more rulemaking and formulation of 340B policies surrounding the president’s drug pricing plan.

June 01, 2018 | Daily News

FDA plans to assemble an internal group that will determine how the agency should move forward with implementing the newly enacted federal Right to Try law, a spokesperson for FDA told Inside Health Policy Friday (June 1).

May 31, 2018 | Daily News

The Community Oncology Alliance is suing the Trump administration for continuing to apply sequestration pay cuts to Medicare reimbursement for doctor-administered drugs.

May 31, 2018 | Daily News

The architect of the new national Right to Try law is already taking FDA Commissioner Scott Gottlieb to task over the agency’s planned implementation of that law.

May 31, 2018 | Daily News

Rheumatologists are putting a hold on designing a provider-pay model that removes rebate-driven middlemen in Medicare Part D while the doctors deal with the administration’s proposals to move Part B drugs to Part D and to revive the Competitive Acquisition Program, according to Madelaine Feldman, vice president of the Council of State Rheumatology Organizations.

May 31, 2018 | Daily News

FDA released long awaited guidance Thursday (May 31) outlining when the agency will waive the requirement that brands and generics share a single safety system, but those following the issue say FDA can only do so much without a change in statute.

May 31, 2018 | Daily News

FDA needs to tread carefully as it tackles the opioid epidemic by focusing on lowering misuse and abuse of prescription drugs to ensure it doesn't in turn cause people to turn to alternative substances and spark a new wave of addiction, FDA Commissioner Scott Gottlieb, drug center Director Janet Woodcock and Deputy Center Director for Regulatory Programs Douglas Throckmorton write in a New England Journal of Medicine article published Wednesday (May 30).

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