Last week, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced an impending reduction in force (RIF) of approximately 10,000 positions, including about 3,500 Food and Drug Administration (FDA)...more
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which describes how FDA intends to apply its drug labeling...more
The U.S. Food and Drug Administration (FDA) has finalized its 2018 draft guidance on “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements,” which offers...more
Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug product labeling...more
Last week, the U.S. Food and Drug Administration (FDA) published the final guidance, “Pre-Launch Activities Importation Requests (PLAIR),” describing its policy regarding requests for the importation of unapproved finished...more
The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” which aims to improve the security...more
A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms – which includes restricting marketing based on “health causes” – takes effect January 19, and may make it more...more
Academic institutions and faculty engaged in developing novel drug therapies are navigating an increasingly complex compliance landscape. ...more
3/26/2021
/ Clinical Trials ,
Drug Design ,
Educational Institutions ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Research and Development ,
Universities
In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for promotional materials that allegedly...more
1/26/2021
/ Advertising ,
Electronic Communications ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Misbranding ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Promotional Items ,
Warning Letters
In Tuesday's Report: FDA warns over drug misbranded as COVID-19 treatment; podcast discusses Trump's "Buy American" executive order; an op-ed on the importance of protecting biomedical innovation; HHS sees high level...more
10/26/2020
/ Biopharmaceutical ,
Buy America ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Life Sciences ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Trump Administration
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
On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical...more
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) allowing distribution of two decades-old malaria drugs — Chloroquine Phosphate and Hydroxychloroquine Sulfate — to treat COVID-19. ...more
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
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 Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,"...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
On August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that...more
Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more
1/23/2017
/ Biologics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
HCEI ,
Healthcare ,
Investigational New Drug Application (IND) ,
Labeling ,
Medical Devices ,
PCORI ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health