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Rx Drugs

January 16, 2020 | Daily News

Nearly half of total 2018 spending on brand name medicines went to the supply chain and brand drug makers are retaining an increasingly smaller share of list prices, according to an industry-funded study by the Berkeley Research Group.

January 16, 2020 | Daily News

Although it’s an off year for state legislatures, states are expected to make progress on legislation and initiatives to lower drug prices, and state attorneys general are showing more interest in protecting residents from high drug prices, according to National Academy for State Health Policy Executive Director Trish Riley.

January 15, 2020 | Daily News

The Government Accountability Office says the Health Resources and Services Administration doesn’t provide enough assurance that nongovernmental hospitals meet 340B eligibility requirements, as it identified several weaknesses in HRSA’s review of nongovernmental hospital contracts that are required for such providers to qualify for 340B discounts.

January 15, 2020 | Daily News

Members of two FDA advisory committees unanimously voted 27-0 against approving Nektar Therapeutics’ oxycodegol opioid for management of chronic low back pain. During the joint committee meeting on Tuesday (Jan. 14), advisors took issue with the lack of efficacy data for broader patient populations, and they were especially disappointed that the sponsor had only conducted one phase III efficacy study.

January 14, 2020 | Daily News

House Energy & Commerce Committee Republican leaders will re-open their 2018 investigation into opioid manufacturers Insys Therapeutics, Mallinckrodt Pharmaceuticals and Purdue Pharma, and the role each company played in the opioid epidemic, lawmakers announced Tuesday (Jan. 14).

January 13, 2020 | Daily News

Federal appellate judges suggested Monday (Jan. 13) that CMS’ attempt to require that drug makers include list prices in television advertisements might lead to consumer confusion without bringing down drug prices.

January 13, 2020 |

The third phase of FDA’s Office of New Drugs restructuring has been pushed back from Jan. 13 to Jan. 21, Peter Stein, director of OND, wrote in an email to industry on Monday (Jan. 13).

January 13, 2020 | Daily News

Opioid abuse, drug compounding and drug shortages are some of the key issues FDA’s drug center will focus on in 2020, drug center director Janet Woodcock said in an email Monday (Jan. 13).

January 13, 2020 | Daily News

The Pew Charitable Trusts and other stakeholders working to stem antimicrobial resistance (AMR) view lawmakers’ plans for a second iteration of the 21st Century Cures Act as an opportunity to enact policies to spur development of new antibiotics.

January 10, 2020 | Daily News

FDA on Thursday (Jan. 9) launched a biotechnology regulation website in collaboration with U.S. Department of Agriculture and the Environmental Protection Agency that is intended to streamline information from the three agencies charged with overseeing agriculture biotechnology products.

January 10, 2020 | Daily News

California Gov. Gavin Newsom is taking a page from President Donald Trump’s playbook by insisting Californians pay no more for drugs than paid by other countries, and if Californians were to get that so-called most-favored-nation status, all state Medicaid programs would get the same deal due to the Medicaid Best Price rule.

January 10, 2020 | Daily News

CMS suggested as part of new guidance laying out ways to avoid duplicate discounts between 340B and Medicaid that states could use state plan amendments to keep some -- or all -- providers and contract pharmacies from using 340B drugs for Medicaid beneficiaries, and 340B hospitals quickly pushed back.

January 09, 2020 | Daily News

FDA must soon update Congress on its plan for regulating cannabidiol (CBD) products, but there are myriad issues the agency still needs to grapple with as that deadline looms.

January 09, 2020 | Daily News

New York Gov. Andrew Cuomo (D) announced his intent to import Canadian drugs, cap insulin costs and rein in drug companies that overcharge patients.

January 08, 2020 | Daily News

FDA has proposed withdrawing more than 200 generic drug applications because the application holders repeatedly failed to file annual reports.

January 08, 2020 | Daily News

More than half of voters consider out-of-pocket costs for prescription drugs and other aspects of health care as top concerns ahead of the first primaries, according to a recent poll from Morning Consult and Bipartisan Policy Center.

January 08, 2020 | Daily News

New York Gov. Andrew Cuomo (D) will advance legislation this year to place fentanyl analogues on the state’s controlled substances list, according to the governor’s 2020 State of the State agenda unveiled Wednesday (Jan. 8).

January 07, 2020 | Daily News

In light of President Donald Trump’s Medicare executive order, CMS is seeking advice on how to eliminate Medicare regulations that are more stringent than state laws and limit what services certain non-physician practitioners can offer.

January 07, 2020 | Daily News

FDA has extended the comment period for its homeopathic draft guidance to March 23, 2020, the agency announced Tuesday (Jan. 7).

January 06, 2020 | Daily News

CMS on Monday (Jan. 6) proposed for 2021 to speed up the transition to a new Medicare Advantage risk-adjustment model and to increase its reliance on encounter data in the first part of the so-called advance notice and call letter for MA and Part D.

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