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Rx Drugs

July 02, 2019 | Daily News

Sen. Elizabeth Warren (D-MA), a contender for the 2020 Democratic presidential nomination, is calling on former FDA Commissioner Scott Gottlieb to step down from his recently announced board of directors position with the pharmaceutical giant Pfizer.

July 02, 2019 | Daily News

FDA on Monday (July 1) eliminated postmarket requirements that makers of HIV prevention drug Truvada and its generics provide training materials to health care professionals and educational information to consumers, due to evidence that most providers and at-risk individuals are aware of the risks of the drug and know how to use it properly.

June 27, 2019 | Daily News

The Senate health committee on Wednesday (June 26) passed, 20 to 3, bipartisan legislation to lower health care costs that includes drug-pricing provisions.

June 27, 2019 | Daily News

Sen. Ron Wyden (D-OR) wants to reverse a Trump-era drug-pricing policy by putting biosimilars in common billing codes to drive down prices of biosimilars, sources following Senate Finance Committee negotiations say.

June 27, 2019 | Daily News

A coalition of patient advocates, provider groups and drug makers is criticizing the Institute for Clinical and Economic Review for using a metric they say discriminates against people with disabilities and chronic illness.

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safety and effectiveness to already-approved analgesics when making future approval decisions, the agency revealed in a draft guidance published Thursday (June 20).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.

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