Special Report from the FDLI Enforcement, Litigation, and Compliance Conference

At the FDLI conference in December 2019, senior FDA officials provided updates on each of the Centers’ 2019 accomplishments and discussed future plans. In addition to the presentations by FDA and DOJ personnel, one given by Validant Principal Consultant Katie Laney on human tissue, cell, and gene therapy enforcement actions is also of note.

I provided in-depth coverage of these presentations in past articles but wanted to combine them into a downloadable report for ease of consumption and future review. This 32-page Special Report covers the topics outlined below.

[NOTE: No need to keep reading, download the full 32-page report now.]

FDLI Special Report - Get Your Copy

FDA Firsts In 2019: First-Of-A-Kind Drug GMP Warning Letters And More To US Than Foreign Firms

Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) Director Donald Ashley

In FY 2019, FDA’s enforcement actions included a number of firsts—for example, the first time in nearly a decade that the agency issued more drug GMP warning letters to sites in the United States than to those overseas; the first warning letter jointly issued by the Center for Drug Evaluation and Research (CDER) and the Drug Enforcement Administration (DEA); and the first warning letter issued for violations of the Drug Supply Chain Security Act (DSCSA).

Director Donald Ashley reviewed these and other firsts from FY 2019.

CDRH Reorganization Takes A Total Product Lifecycle Approach; MDSAP, ISO Adoption, And Collaboration With MDIC Moving Forward

Center for Devices and Radiological Health (CDRH) Associate Director of Compliance and Quality Erin Keith

Did you know that CDRH no longer has an Office of Compliance?  Would you like to know where those functions went?

CDRH’s Associate Director for Compliance and Quality Erin Keith explains the Center’s completely revamped organization structure that was finalized late last fall, its progress on international harmonization efforts, and the changing face of its compliance program.

Human Cell And Tissue Therapy Enforcement Actions Target Unapproved New Products Making Unsubstantiated Claims

Center for Biologics Evaluation and Research (CBER) Office of Compliance and Biologics Quality Deputy Office Director Melissa Mendoza

FDA’s Center for Biologics Evaluation and Research (CBER) is overcoming daunting challenges in its enforcement of laws and regulations in the area of human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are being sold without the required FDA approval.

While some companies are submitting applications to CBER seeking agency approval for marketing HCT/Ps, others are marketing and administering products they claim will treat various diseases and life-threatening conditions—including cancer, amyotrophic lateral sclerosis (ALS), Alzheimer’s, autism, arthritis, stroke, Multiple Sclerosis (MS), macular degeneration, Parkinson’s disease, chronic obstructive pulmonary disease (COPD), and many others—without proof of the claims and without agency approval.

Deputy Office Director Melissa Mendoza reviewed the challenges her office is facing and the enforcement and litigation actions the Center took in 2019.

Department Of Justice Consumer Protection Branch Doubles In Size To Battle Fraud And Deception In The Drug And Dietary Supplement Industries

Department of Justice (DOJ) Consumer Protection Branch (CPB) Deputy Assistant Attorney General David Morrell

In the last two years, the Department of Justice (DOJ) Consumer Protection Branch (CPB)—responsible for investigating and litigating civil and criminal violations of the Food, Drug, and Cosmetic Act (FDCA) and the Controlled Substances Act (CSA)—has nearly doubled its number of attorneys and more than tripled its support staff of law clerks, paralegals, and investigators to battle fraud and deception in the drug and dietary supplement industries.

While FDA that administers FDCA and the U.S. Drug Enforcement Administration (DEA) that oversees the CSA have their own enforcement tools, CPB gets involved if those tools fail to bring a bad actor into compliance.

Deputy Assistant Attorney General David Morrell reviewed highlights of the CPB’s enforcement work from 2019 and discussed how that work portends future action.

Avoiding And Reacting To Human Tissue, Cell And Gene Therapy Enforcement Actions: Communication Is Key

Validant Principal Consultant Katie Laney

In the final two months of the calendar year 2019, FDA’s Center for Biologics Evaluation and Research (CBER) took compliance actions against human tissue, cell, and gene therapy manufacturers that included the issuance of Untitled Letters, Warning Letters, and an administrative action to cease manufacturing.  These took place when the agency was in a period of enforcement discretion, which will come to an end in November.

Validant Principal Consultant Katie Laney explained ways in which manufacturers of human tissue, cell, and gene therapy products might avoid FDA enforcement actions, and how to address those actions if they take place.

[NOTE: Have your own copy of the conference coverage—download the full 32-page report now.]

FDLI Special Report - Get Your Copy

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