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Rx Drugs

June 21, 2019 | Daily News

The White House budget office began reviewing CMS’ proposal to base Medicare Part B drug prices on prices paid abroad, increasing pressure on Senate Finance Committee members to reach a deal on alternative changes to the doctor reimbursement system for drugs and on industry to support those changes.

June 20, 2019 | Daily News

FDA wants to hear from stakeholders on whether new preapproval incentives are needed to encourage development of safer pain and addiction therapies at a public hearing slated for Sept. 17.

June 20, 2019 | Daily News

FDA will take into account a proposed opioid’s broader public health effects, including on non-users, and look at how the product compares in safety and effectiveness to already-approved analgesics when making future approval decisions, the agency revealed in a draft guidance published Thursday (June 20).

June 20, 2019 | Daily News

After two months as FDA Acting Commissioner, Ned Sharpless said he would like to be nominated for the position permanently, though he acknowledged the decision ultimately lies with The White House.

June 20, 2019 | Daily News

FDA drug center chief Janet Woodcock urged senators Wednesday (June 19) to reform the over-the-counter drug regulatory system to boost the self-care industry and save consumers money, marking the second time in the past few days that the issue has cropped up at Senate hearings on health care costs.

June 20, 2019 | Daily News

The House passed legislation Tuesday (June 18) to stop authorized generics from lowering the rebates that drug companies must pay in Medicaid. The rebate measure was also included in the president’s budget request.

June 20, 2019 | Daily News

FDA on Thursday (June 13) released draft guidance meant to help industry conduct tests on assisted reproduction technology (ART) devices, in order to ensure companies screen for toxicity.

June 19, 2019 | Daily News

The House late on Tuesday (June 18) passed legislation that would fund the Money Follows the Person demonstration through 2024, preserve asset protections for the spouses of Medicaid beneficiaries who receive long term care benefits and extend the Community Mental Health Services Demonstration.

June 19, 2019 | Daily News

Despite Senate health committee Chair Lamar Alexander’s (R-TN) ongoing concerns with the 340B drug discount program, 340B reforms were not included in the latest version of the committee’s cost-cutting legislation introduced by Alexander and ranking Democrat Patty Murray (WA) Wednesday (June 19).

June 19, 2019 | Daily News

Senate Finance Committee Chair Chuck Grassley opposes indexing prices of Medicare Part B drugs to those in foreign countries, but the Iowa Republican thinks that third-party vendors should negotiate prices for Part B specialty drugs that are in short supply.

June 19, 2019 | Daily News

Senate health committee Chair Lamar Alexander (R-TN) and ranking Democrat Patty Murray (WA) ultimately decided not to include drug-pricing provisions that would tie patient coinsurance to net prices instead of list prices and require drug makers to justify price hikes in the committee’s final package on lowering health care costs.

June 19, 2019 | Daily News

The Senate health committee’s latest health cost-containment legislation adds funding for community health centers, the National Health Service Corps, teaching health center Graduate Medical Education and special diabetes programs through fiscal 2024, as well as including a new section to strengthen mental health parity and additional drug pricing provisions.

June 18, 2019 | Daily News

FDA has expanded its patent certification list to include additional data that can help subsequent generic drug applicants determine when their products can be approved and marketed, the agency announced Tuesday (June 18).

June 18, 2019 | Daily News

American Hospital Association Executive Vice President Tom Nickels said the group plans to make information from 1,100 hospitals on how they use the 340B drug discount program public and to share information from AHA’s voluntary transparency initiative with the Health Resources and Services Administration.

June 18, 2019 | Daily News

Senate health committee Chair Lamar Alexander (R-TN) told Sen. Robert Casey (D-PA) and the rest of the health committee he is committed to finding a path forward for over-the-counter drug monograph reform legislation that has stalled in the Senate.

June 18, 2019 | Daily News

Some biologics experts are perplexed by the Trump administration’s argument that subjecting biologics products to United States Pharmacopeia (USP) monographs would hamper innovation.

June 18, 2019 | Daily News

Americans for Safe Access and data company Aurelius Data Inc. have partnered to develop a research platform that will compile use, perception and biometric data on consumers who are using cannabis products to help their medical conditions, and will make those insights available in a subscription-based database that allows users to see what regimens patients are using.

June 18, 2019 | Daily News

Senate health committee Chair Lamar Alexander (R-TN) said Tuesday (June 18) that his committee will mark up its bipartisan legislation to lower health costs next week.

June 17, 2019 | Daily News

The Pharmaceutical Research and Manufacturers of America is running attack ads that say AARP cares more about insurers than seniors, but AARP says the poll that PhRMA is relying on for that message is so misleading that the seniors’ group filed a complaint with the organization that guards against push polling.

June 17, 2019 | Daily News

Former FDA Commissioner Scott Gottlieb named payer tactics as one of the biggest obstacles facing the gene therapy space, as novel drugs seeking coverage after receiving FDA approval are often viewed by payers as not having enough data on which to base a coverage decision.

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