Group Comment Letter to FDA on Clinical Immunogenicity Considerations from Biosimilar and Interchangeable Insulin Products
Dear Commissioner Hahn,
The undersigned groups share the Food and Drug Administration’s (FDA) deep commitment to the development of a robust biosimilars market and appreciate the Agency’s work to develop an efficient approval pathway for biosimilars to bring savings and access to America’s patients. As such, we support the approach outlined in the “Clinical Immunogenicity Considerations from Biosimilar and Interchangeable Insulin Products” draft guidance. Specifically, we agree with the Agency’s assessment that if a manufacturer demonstrates its proposed biosimilar insulin is “highly similar” to its reference product, the Agency may waive the need for the manufacturer to conduct additional immunogenicity studies in order for the Agency to deem the product as interchangeable with its reference product.
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Lear MoreComments of the Healthcare Supply Chain Association (HSCA) on FDA Request for Comments on Ethylene Oxide Sterilization of Medical Devices
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments to the U.S. Food and Drug Administration (FDA) regarding the use of Ethylene Oxide (EtO) to sterilize medical devices.
HSCA represents the nation’s leading healthcare group purchasing organizations (GPOs), the sourcing and purchasing partners to virtually all of America’s 7,000+ hospitals, as well as the vast majority of the 68,000+ long-term care facilities, surgery centers, clinics, and other healthcare providers. GPOs work with healthcare providers to support a safe and reliable supply of healthcare products. We help ensure quality medical products at the best value for patients, hospitals, payers, Medicare and Medicaid, and taxpayers. The value that GPOs deliver allows healthcare providers and physicians to focus on their core mission: providing first-class patient care.
HSCA and its member GPOs have a unique line of sight over the entire healthcare supply chain – from raw materials to the manufacturing process for drugs and medical devices to their delivery to patients. Even seemingly minor disruptions to the healthcare supply chain could have significant consequences for patients. In that vein, we appreciate the Agency’s efforts to seek feedback and input on this critical matter.
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Lear MoreHSCA Submits Comments to ANSI on Healthcare Supply Chain Data Standards to Help Improve Accuracy, Efficiency, and Patient Safety
Washington, DC (November 26, 2019) – The Healthcare Supply Chain Association (HSCA) Committee for Healthcare eStandards (CHeS) today submitted comments to the American National Standards Institute’s (ANSI) Accredited Standards Committee (ASC) X12 supporting the Committee’s recommendation to include medical device identifiers in the healthcare electronic claim form.
The vast majority of healthcare insurance claims are communicated electronically, using electronic data interchange (EDI) standards that are promulgated and maintained by the ASC X12 Committee. The ANSI ASC X12 Committee is currently proposing a number of changes to the electronic healthcare claim form, including adding medical device identifiers to the form to enable providers and payers to exchange product information.
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Lear MoreHSCA Statement on FDA Drug Shortages Task Force Report
Washington, DC (October 29, 2019) – Healthcare Supply Chain Association (HSCA) President and CEO Khatereh Calleja today released the following statement regarding the recent report by the Food and Drug Administration (FDA) Drug Shortages Task Force on drug shortages:
“Ongoing critical prescription drug shortages jeopardize patient access to essential medications. As FDA has noted, the causes of drug shortages are complex and multifactorial, requiring an all-hands-on-deck, multi-stakeholder solution. HSCA and its member group purchasing organizations (GPOs) are on the front lines of helping providers prevent and mitigate drug shortages, working collaboratively with hospitals, physicians, manufacturers, distributors, and government agencies to ensure that providers and patients have access to the life-saving drugs they need.
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Lear MoreComments of the Healthcare Supply Chain Association (HSCA) on Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2020
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments on the U.S. Drug Enforcement Administration’s (DEA or Agency) proposed aggregate production quotas for Schedule I and II controlled substances. HSCA supports DEA’s efforts to support interagency collaboration around controlling opioid diversion. We are concerned, however, that absent differentiation of injectable opioids from solid dosage form for purposes of the rule, these changes to aggregate production quotas could lead to injectable narcotic shortages that threaten patient care.
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Lear MoreHSCA CEO to Lead Panel Discussion on Innovation at AdvaMed’s MedTech Conference
Washington, DC (September 23, 2019) – The Healthcare Supply Chain Association (HSCA), the association representing the nation’s leading healthcare group purchasing organizations (GPOs), today announced HSCA President and CEO Khatereh Calleja will moderate a panel on “Chasing Value: Understanding How to Work with GPOs to Introduce New Health Care Innovation in the Supply Chain” at AdvaMed’s MedTech Conference on Monday, September 23rd at the Boston Convention and Exhibition Center in Boston, Massachusetts.
The panel will feature healthcare leaders from Vizient, Premier, Intalere, 410 Medical, and Access Scientific. Panelists will discuss successful partnerships, best practices and how they have successfully worked together and launched new innovations.
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Comments of the Healthcare Supply Chain Association (HSCA) on USTR Request for Comments on the Proposed Modification of Action Pursuant to Section 301
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments to the U.S. Trade Representative (USTR) on the proposed modification of action regarding Chinese exports under Section 301.
Click here for the full comments.
Lear MoreHSCA Applauds FDA for Releasing New Data to Enable Generic Competition
Washington, DC (June 19, 2019) – Healthcare Supply Chain Association (HSCA) President and CEO Khatereh Calleja today released the following statement applauding the U.S. Food and Drug Administration (FDA) for releasing new data to help generic drug competitors:
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Lear MoreNew Analysis of U.S. Health Data Finds Healthcare Group Purchasing Organizations Save Healthcare System, Medicare and Medicaid, and Taxpayers Up to $34.1 Billion Annually
Analysis of CMS expenditure data finds that GPOs will reduce healthcare spending by $456.6 billion over the next ten years
Washington, DC (May 15, 2019) – The Healthcare Supply Chain Association (HSCA), which represents the nation’s leading healthcare group purchasing organizations (GPOs), today announced a new analysis of data from the Centers for Medicare and Medicaid Services (CMS) found that GPOs save the healthcare industry up to $34.1 billion annually and will reduce healthcare spending by up to $456.6 billion over the next ten years. The report, conducted by healthcare economists at Dobson DaVanzo & Associates, found that GPOs reduce supply-related purchasing costs to nursing homes and hospitals by 13.1 percent compared to providers who do not use GPO services.
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Lear MoreHSCA Names Leading National Healthcare Expert Khatereh Calleja as President & CEO
Washington, DC (April 2, 2019) – The Healthcare Supply Chain Association (HSCA) Board of Directors is
pleased to announce that it has named leading national healthcare expert Khatereh Calleja as President
and CEO of the Healthcare Supply Chain Association, effective April 29, 2019. Calleja joins HSCA from
AdvaMed, the world’s largest association representing manufacturers of medical devices, diagnostic
products, and medical information systems, where she served as Senior Vice President of Technology
and Regulatory Affairs.
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