On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingestible drugs. This ban...more
In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more
6/1/2023
/ Biologics ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Centers ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment ,
Regulatory Requirements ,
Scientific Research
The U.S. Food and Drug Administration (FDA) has taken formal steps to prevent and mitigate drug shortages for over a decade. While the problem predates the COVID-19 pandemic, the pandemic presented potential new challenges...more
In this week’s episode, Richard Church interviews Michael Hinckle about FDA inspections of health care providers. They discuss why an inspection might come up, what providers should expect, the do’s and don’ts of inspection...more
A recent Federal Circuit court decision promises to significantly impact and broaden the scope of the types of foreign-produced pharmaceutical products companies can sell to the U.S. government.
...more
On January 31, 2019, the U.S. Department of Health & Human Services (“HHS”) issued a long-awaited proposed rule (the “Proposed Rule”) which, if finalized, would modify the discount safe harbor under the federal Anti-Kickback...more
2/12/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Rebates ,
Safe Harbors
The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this...more
Recent developments from the Trump administration relating to the 340B Drug Pricing Program (“340B Program”) could have a significant impact on covered entities, drug manufacturers, and others. In particular, the President’s...more
On March 20, 2017, the Health Resources and Services Administration (“HRSA”) published in the Federal Register an Interim Final Rule delaying the effective date of regulations relating to drug pricing and civil monetary...more
The European Union (“EU”) and the United States (“US”) have reached a sectoral agreement (the “Agreement”) that will greatly ease the administrative burden when proving compliance with Pharmaceutical Good Manufacturing...more
In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more
10/26/2015
/ Administrative Procedure Act ,
Affordable Care Act ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Facilities ,
HRSA ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Section 340B
On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the...more
6/24/2015
/ Affordable Care Act ,
Civil Monetary Penalty ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare ,
HRSA ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Regulation ,
Section 340B
On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more
Biologic drugs have become increasingly popular in recent years, and now serve as standard treatment options for diseases such as diabetes, anemia, cancer, hepatitis, and multiple sclerosis. Biologics are a class of drugs or...more
Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more
On October 31, 2013, the U.S. Food and Drug Administration (“FDA”) unveiled its latest steps for preventing and resolving prescription drug shortages. First, the agency announced a proposed rule requiring manufacturers of...more
On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more