On Dec.30, 2020, the Department of Health and Human Services (HHS) Office of the General Counsel released an advisory opinion concluding that drug manufacturers are obligated to deliver discounts under the 340B Drug Pricing...more
On Dec. 10, the United States Supreme Court issued its ruling in Rutledge v. Pharmaceutical Care Management Association. The Court reversed the 8th Circuit to uphold a state’s ability to regulate the price at which pharmacy...more
12/14/2020
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Health Insurance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Preemption ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
SCOTUS
Food/Dietary Supplements -
FDA Releases Final Serving Size Guidance – The guidance is intended to “help manufacturers of packaged foods comply with the FDA’s updated Nutrition Facts labeling regulations. ...more
Food/Dietary Supplements -
FDA Warns Consumers Not to Use Certain Products Following Consent Decree – The FDA issued a warning to consumers to steer clear of certain drug, dietary supplement and medical device products...more
Food/Dietary Supplements -
FDA Acting Commissioner Remarks on Smarter Public Food Safety – Dr. Sharpless stated, “I have been [a] strong proponent of leveraging new and emerging technologies and of developing novel analytical...more
Food/Dietary Supplements -
FDA to Hold Public Meeting on Food Standards of Identity – The FDA will hold a public meeting “to give interested persons an opportunity to discuss FDA’s effort to modernize food standards of...more
Food/Dietary Supplements -
FDA Suspends Food Facility Registration – The FDA announced the suspension of a Texas-based seafood producer....more
Food/Dietary Supplements -
FDA Issues Report on Certain Dog Foods – The Food and Drug Administration (FDA) continues to investigate cases of dilated cardiomyopathy (DCM) in dogs consuming certain dog foods. ...more
7/2/2019
/ Centers for Disease Control and Prevention (CDC) ,
Cybersecurity ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Transparency ,
Trump Administration ,
Warning Letters
Food/Dietary Supplements -
FDA Releases Food Contact Guidance – The FDA published a guidance titled “Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk:...more
Sharpless Begins as FDA Acting Commissioner – On April 5, Norman E. “Ned” Sharpless, M.D., became the acting commissioner of the FDA. Previously he was the director of the National Cancer Institute....more
Food/Dietary Supplements -
FDA Announces Plans to Strengthen Food Safety Program – The FDA proposed new funding under the 2020 budget to address multiple areas of the food safety system. ...more
Food/Dietary Supplements -
FDA Continues Critical Food Programs During Shutdown – Food and Drug Administration (FDA) Commissioner Scott Gottlieb tweeted: “We’ve received multiple inquiries about which critical food...more
Food/Dietary Supplements - FDA Investigates Multiple Foodborne Illness Outbreaks – The FDA and the CDC have launched a multistate investigation of a Salmonella Concord outbreak linked to certain tahini products. ...more
12/4/2018
/ 510(k) RTA ,
Animal Drugs ,
Centers for Disease Control and Prevention (CDC) ,
CLIA ,
Dietary Supplements ,
Drug Pricing ,
E-Cigarettes ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Medicare Advantage ,
Medicare Part D ,
Pharmaceutical Industry ,
Section 340B
Food/Dietary Supplements - FDA Issues Added Sugar Guidance – The FDA announced the availability of a guidance document that answers questions about the new food labeling requirements. ...more
Last week Health and Human Services (HHS) released its Statement of Regulatory Priorities for Fiscal Year 2019. Several of the FY19 priorities include: (1) combatting the opioid crisis; (2) strengthening individual health...more
As U.S. spending on pharmaceuticals continues to rise, reaching $373.9 billion in 2014, government scrutiny of drug pricing practices has increased in response.
Early last year, the U.S. Department of Health and Human...more
On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more
9/11/2015
/ AIDS ,
Audits ,
Compliance ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
FQHC ,
GPOs ,
Healthcare ,
HRSA ,
Managed Care Contracts ,
MCOs ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B