Safe Biologics

JANUARY 6, 2024

CMS accepted public comments on the Proposed Rule until January 5, 2024. ASBM was among the organizations which submitted comments. ASBM’s comments read, in part: Automatic substitution of biosimilars is highly controversial among physicians and is banned in many countries, including most of Europe.

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Biosimilars 100

Safe Biologics

DECEMBER 3, 2023

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars. Read the new FDA Guidance here.

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Safe Biologics

JANUARY 12, 2024

Participants discussed how the price-setting policy will result in fewer drugs being developed, reduced patient access to these medicines, and will likely fail to control costs as its proponents claim. ASBM submitted comments opposing the proposal and defending the current state law. View video of the podcast here.

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Biosimilars Drug Pricing 130

PhRMA

JULY 12, 2023

This week, PhRMA submitted comments to the U.S. In our comments, we expressed our strong opposition to policy proposals that would inhibit the biopharmaceutical industry partnering with the government to address pressing public health needs.

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Safe Biologics

FEBRUARY 1, 2024

Comments may be submitted here until April 30, 2024. ASBM’s comments read, in part: Automatic substitution of biosimilars is highly controversial among physicians and is banned in many countries, including most of Europe. Read ASBM’s full comments on the proposed policy here.

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Biosimilars Documentation Drug Pricing 130

Express Pharma

MARCH 5, 2024

As a Member of the Task Force, Nutraceutical Council to PSA office, Government of India, he also comments on how enabling policies can elevate India’s Nutraceuticals sector on the global stage.

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Communication 102

PhRMA

JANUARY 31, 2023

PhRMA recently submitted comments to the Office of the U.S. The comments highlight foreign government actions and policies that undermine American innovation, biopharmaceutical leadership and more than 4.4 Trade Representative (USTR)’s 2023 Special 301 Report. million American jobs.

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PhRMA

JUNE 7, 2023

The Inflation Reduction Act (IRA) makes significant changes to Part D’s benefit structure and coverage, which will require careful policy development and thoughtful implementation.

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Drug Channels

MARCH 21, 2024

I found Mark’s comments to be intriguing and highly provocative, so I invited him to publish an edited version exclusively here on Drug Channels. How will the most consequential change in federal drug pricing policy affect drug pricing? Read on for Mark’s unfiltered view of the PBM industry.

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Drug Pricing 98

European Pharmaceutical Review

MAY 9, 2024

For instance, identifying what regulations or guidance needs amendment or the potential need for new such policies or rules. A sign-on letter from 6,000 industry members was also obtained.

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Communication 67

PhRMA

MARCH 21, 2023

The White House’s Office of Science and Technology Policy (OSTP) recently solicited stakeholder feedback on the clinical research infrastructure for emergency clinical trials, for which PhRMA submitted comments.

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Safe Biologics

NOVEMBER 12, 2023

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. Comments may be submitted here.

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Biosimilars Drug Pricing Packaging Labelling 130

PhRMA

OCTOBER 7, 2022

PhRMA submitted comments this week in response to the Department of Health & Human Services (HHS) proposed rule on the Nondiscrimination in Health Programs and Activities.

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PhRMA

APRIL 14, 2023

In comments submitted to CMS , PhRMA outlined key concerns with the guidance and the underlying policy and recommendations to mitigate the harm of the price setting scheme.

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Drug Channels

AUGUST 8, 2023

senators issued a request for information (RFI) for “input on bipartisan policy solutions that would provide stability and appropriate transparency to ensure the 340B program can continue to achieve its original intent of supporting entities serving eligible patients.” Recently, a bipartisan group of six U.S. I shared my $0.02

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Drug Pricing Hospitals 72

PhRMA

MARCH 20, 2023

Recent PhRMA comments to the U.S. trade policies that expand market access, protect American intellectual property (IP) rights and address unfair trade barriers abroad. According to the report, U.S. exports of pharmaceutical preparations exceeded $90 billion in 2022 — an increase of $7 billion over the previous year.

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PhRMA

MARCH 1, 2023

Food and Drug Administration (FDA) are in the process of considering new collaboration initiatives aimed at biopharmaceutical patents.

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Drug Development 83

Putting Patients First Blog

SEPTEMBER 11, 2023

NHC comments on the 2024 Physician Fee Schedule September 11, 2023 By: Allen Pinn, Coordinator, Policy On July 13, the Centers for Medicare & Medicaid Services (CMS) released their proposed rule for the 2024 Physician Fee Schedule. Below is a summary of the NHC’s comments submitted September 11, 2023.

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Drug Pricing 59

Putting Patients First Blog

NOVEMBER 13, 2023

The comments submitted by the NHC supported increased efforts to eliminate discrimination against people with disabilities and kept patients’ experiences and access to health care at the forefront. Below is a summary of the comments. Conclusion To read the NHC’s full comments, click here.

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Communication 52

European Pharmaceutical Review

MAY 2, 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a policy paper on its strategic approach to artificial intelligence (AI). It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023.

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Express Pharma

NOVEMBER 22, 2023

India must utilise its technical resources, demographic dividend, skilled manpower, forward-looking government policies, and economies of scale to become a world leader in pharmaceuticals. Do we have the right policies, infrastructure, and mindset to achieve these aspirations?

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Vaccines 92

Express Pharma

NOVEMBER 1, 2023

Commenting on the recognition, Archana Bhaskar, Chief Human Resources Officer, Dr Reddy’s said, “We are proud to be recognised by Science Magazine for the second year in a row in its global top 20 pharma employers list. Reddy’s is placed at number 16, marking a year-on-year improvement of two places.

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Putting Patients First Blog

FEBRUARY 5, 2024

A Reminder of NHC Benefits February 5, 2024 By: Bob Scott, Director, Member Services The National Health Council (NHC) brings diverse organizations together to forge consensus, drive patient-centered health policy, and provide a united voice for the more than 160 million people with chronic diseases and disabilities and their family caregivers.

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Documentation Communication 59

European Pharmaceutical Review

MAY 16, 2024

According to GSK, The Fleming Initiative’s will gather “world-class scientific, technology, policy and behavioural science expertise with clinical experience in a global network of centres to find, test, and scale solutions to [antimicrobial resistance] (AMR)”.

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Safe Biologics

DECEMBER 6, 2023

The policy change represents a stark departure from the perspectives of the U.S. The FDA will be accepting comments on the draft guidance through Nov. Comments may be submitted here. Submit comments on the guidance here. Read the new FDA Guidance here.

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Putting Patients First Blog

JANUARY 16, 2024

NHC 2025 Notice of Benefit and Payment Parameters (NBPP) Comments January 16, 2024 Allen Pinn, Coordinator, Policy The National Health Council (NHC) submitted comments to the Centers for Medicare and Medicaid Services (CMS) regarding the 2025 Notice of Benefit and Payment Parameters (NBPP) on January 8.

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Insurance Coverage and Processing Communication 59

European Pharmaceutical Review

NOVEMBER 16, 2023

The report noted that biosimilar adoption levels vary significantly across Europe because of differences in baseline use of biologics, biosimilar reimbursement, procurement, policies, and education, based on research published in a paper in the Journal of Market Access & Health Policy in 2017.

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Biosimilars 87

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

2, 2024, FDA’s Center for Veterinary Medicine (CVM) announced that it will withdraw its Program Policy and Procedures Manual Guide 1240.3605 (PPM). CVM invited the public and stakeholders to comment on FDA’s regulation of animal foods with certain types of claims, that under the now withdrawn PPM, would be considered drug claims.

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Putting Patients First Blog

SEPTEMBER 21, 2023

Fall Federal-State Roundtable Recap September 21, 2023 By: Allen Pinn, Coordinator, Policy The National Health Council (NHC) held its second Federal-State Policy Roundtable on September 19, 2023. The Roundtable gathered over 60 federal and state policy professionals from NHC’s membership from across the nation.

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Drug Pricing 52

Putting Patients First Blog

SEPTEMBER 11, 2023

Created by and for patient organizations over 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. Our specific comments are included below. We promote increased access to affordable, high-value, sustainable health care. Sincerely, Randall L.

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FDA Law Blog: Biosimilars

JUNE 5, 2023

The evidentiary recommendations and guidelines outlined in the Format are used by manufacturers and health care decisions-makers to inform coverage, policy, and reimbursement decisions for medical products. Please review the proposed revisions to the Format and provide your comments in this form by June 30.

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Putting Patients First Blog

JULY 18, 2023

Washington Representatives Summer Meeting Overview July 18, 2023 By: Allen Pinn, Coordinator, Policy After much anticipation, the NHC held its inaugural Washington Representatives Summer meeting at Top of the Hill (TOTH) in Washington, DC. Below is an overview of the sessions during the meeting.

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Packaging Biosimilars 52

Putting Patients First Blog

NOVEMBER 27, 2023

Recap: 2023 Washington Representatives Retreat November 27, 2023 By: Bhriana Onuoha, Senior Coordinator, Communications Last week, over 100 policy professionals from the National Health Council’s (NHC) membership gathered in Annapolis, MD, for the NHC’s annual Washington Representatives Retreat. Fishman led the Latest from CMMI session.

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Communication 52

Putting Patients First Blog

NOVEMBER 28, 2023

Created by and for patient organizations more than 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. In addition, payment policies, including cost-sharing requirements, and provider networks must still support access and in-person availability.

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Communication 40

Express Pharma

MAY 19, 2023

“Tweak in policy is mooted,” the document from the prime minister’s office said, adding that “important things” had been “overlooked” It did not elaborate. Modi’s office and the health ministry did not respond to a request for comment. com reported on Tuesday. .”

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Putting Patients First Blog

OCTOBER 15, 2023

Created by and for patient organizations more than 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. However, the NHC strongly opposes policies that achieve savings if they negatively impact patient safety, quality, or access to existing or future care.

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Insurance Coverage and Processing 40

Putting Patients First Blog

AUGUST 28, 2023

Since a strong CED pathway is critical to increasing access to breakthrough technologies, we submit our comments on TCET as an addition to our comments on the new CED guidance. Patient Engagement In our comments on the proposed CMS guidance on CED, the NHC offered the following recommendation on patient engagement.

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