After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more
On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of multiple myeloma. The decision came...more
Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives.
Originally published in Law360 - September 11, 2023....more
12/11/2023
/ Advertising ,
Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Marketing ,
Misleading Statements ,
Pharmaceutical Industry ,
Prescription Drugs ,
Social Media
On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved...more
What is the COVID-19 Trademark Prioritized Examination Program? In an effort to address the critical need to develop medical products and services that will aid in the elimination of the COVID-19 pandemic, the United States...more
In response to a wave of questions from organizations looking to contribute to the fight against COVID-19, HHS recently clarified the bounds of immunity under the Public Readiness and Emergency Preparedness (PREP) Act, which...more
On March 18, the Food and Drug Administration (FDA) issued guidance in recognition of the extraordinary challenges that have impacted ongoing medical research in light of the coronavirus pandemic. “FDA Guidance on Conduct of...more
Can a pharmaceutical manufacturer provide free items or services to financially needy Medicare and Medicaid beneficiaries without running afoul of the Beneficiary Inducements Civil Monetary Penalty (CMP) or the Anti-Kickback...more
2/11/2019
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Digital Health ,
Low-Income Issues ,
Medicaid ,
Medical Devices ,
Medicare ,
OIG ,
Patient Assistance Programs ,
Pharmaceutical Industry
HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more
The update to the Fiscal Year 2015 Annual Work Plan includes new initiatives that may affect pharmaceutical companies and Medicare Part D payors and pharmacies.
Annually, the Department of Health and Human Services...more
6/15/2015
/ Department of Health and Human Services (HHS) ,
Healthcare ,
Medicaid ,
Medicaid Reimbursements ,
Medicare ,
Medicare Part D ,
OIG ,
Payor Contracts ,
Pharmaceutical Industry ,
Pharmacies ,
Reporting Requirements