August 15th, 2019 Norman Sharpless, MD Acting Commissioner Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2019-D-1536 for “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.” Submitted electronically via regulations.gov Dear Acting Commissioner Sharpless, On behalf of the Global Healthy Living Foundation (GHLF), thank you for the opportunity […]
August 13th, 2019 The Honorable Alex M. Azar II Secretary U.S. Department of Health and Human Services 200 Independence Avenue, SE Washington, DC 20201 Re: Nondiscrimination in Health and Health Education Programs or Activities [HHS–OCR–2019–0007] [RIN 0945–AA11] Submitted electronically via federalregister.gov Dear Secretary Azar, The Global Healthy Living Foundation (GHLF) is a 20-year-old 501(c)(3) patient […]
April 2, 2019 Department of Health and Human ServicesOffice of Inspector GeneralAttention: OIG-0936-P Cohen Building, Room 5527330 Independence Avenue, SWWashington, DC 20201RE: “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy BenefitManager […]
April 1st, 2019 Alex Azar, JD Secretary, US Department of Health and Human Services 330 C Street SWWashington, DC 20416 Re: Pain Management Best Practices Inter-Agency Task Force Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations (HHS-OS-2018-0027)Comments submitted electronically at www.regulations.govDear Secretary Azar,Thank you for the opportunity to submit comments on […]
March 27, 2019 Submitted electronically via www.regulations.gov Honorable Alex AzarSecretaryDepartment of Health and Human Services 200 Independence Avenue, SWWashington, DC 20201Seema VermaAdministratorCenters for Medicare & Medicaid ServicesP.O. Box 8013Baltimore, MD 21244-1850Preston RutledgeAssistant Secretary Employee Benefits Security AdministrationDepartment of Labor200 Constitution Avenue, NWWashington, DC 20210Victoria JudsonAssociate Chief Counsel (Employee Benefits, Exempt Organizations, and Employment Taxes)Internal Revenue […]