Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These...more
10/26/2020
/ Coronavirus/COVID-19 ,
Enforcement Actions ,
False Advertising ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Misbranding ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Safety Standards ,
Warning Letters
Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more
7/23/2019
/ Biotechnology ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Imports ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Standards ,
Rulemaking Process ,
Secretary of HHS ,
Supply Chain ,
Working Groups
FDA authority to crack down on illegally marketed stem cell treatments confirmed -
On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug...more
6/7/2019
/ Biologics ,
Food and Drug Administration (FDA) ,
Fraudulent Marketing ,
Health Care Providers ,
Health Clinics ,
Life Sciences ,
Pharmaceutical Industry ,
PHSA ,
Regulatory Oversight ,
Regulatory Standards ,
Stem cells
Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy published by the International Committee of Medical...more
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more
10/24/2018
/ Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Compelled Speech ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Price Transparency ,
Proposed Rules ,
Registration Requirement ,
Regulatory Oversight ,
Television Commercials ,
Trump Administration
On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."
...more
On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor, Health and Human Services (HHS), and Education, attaching to it a large...more
8/29/2018
/ Advertising ,
Disclosure Requirements ,
Drug Pricing ,
Legislative Agendas ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Transparency
On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as “consistent with" FDA-required labeling. FDA...more
The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from pharmaceutical manufacturers, although the expected final rule is less...more
Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777,...more