Joanne Hawana at Mintz

Eighth Circuit Issues Decision Significant for All Executives of FDA-Regulated Businesses

On July 6, 2016, the Eighth Circuit Court of Appeals issued its ruling in United States v. DeCoster, in which it upheld prison sentences for two executives under the “responsible corporate officer” (RCO) doctrine of...more

7/13/2016 / Appeals , Corporate Counsel , Enforcement Authority , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Park Doctrine , Responsible Corporate Officer Doctrine , Salmonella

FDA Comes Through on Promise to Release NGS Device Draft Guidelines Expeditiously

Building on last year’s public workshops related to Next-Generation Sequencing (NGS) and expanding its efforts to advance the Obama Administration’s Precision Medicine Initiative, the FDA late last week released two draft...more

7/13/2016 / Diagnostic Tests , DNA , Draft Guidance , Food and Drug Administration (FDA) , Precision Medicine Initiative (PMI)

6-Month Notice from a Biosimilar Sponsor Always Required — Says Federal Circuit

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new...more

7/6/2016 / Affordable Care Act , Amgen , Apotex , Biologics , Biosimilars , BPCIA , Food and Drug Administration (FDA) , Patent Dance , Patent Infringement , Preliminary Injunctions

Congress Proposes Legislative “Fixes” to Drug Industry Rules Believed to Be Contributing to High Costs

We spend a lot of time covering prescription drug costs on this blog, and even convened a Pharmacy Industry Summit earlier this year focusing on the various pressures that are contributing to higher drug prices. Although...more

6/30/2016 / Biologics , Drug Pricing , Exclusivity , Generic Drugs , Pharmaceutical Industry , Prescription Drugs , Proposed Legislation

The Last Set of Major FSMA Regulations Are Done!

The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency...more

6/17/2016 / Final Rules , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , FSMA , Public Safety , Risk Mitigation

OTC Drug Regulatory Paradigm Open to Stakeholder Feedback Until July 10

Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the...more

6/14/2016 / FDA Approval , Food and Drug Administration (FDA) , Over The Counter Derivatives (OTC) , Prescription Drugs , User Fees

Senate Appropriations Bill Targets FDA Rulemaking Agenda

The Senate Appropriations Committee is looking to tinker with the Food and Drug Administration’s rulemaking agenda through its fiscal year 2017 funding bill for the Department of Agriculture and FDA (S. 2956). Passed...more

6/9/2016 / Appropriations Bill , Food and Drug Administration (FDA) , Food Labeling , Labeling , Legislative Agendas , Menu-Labeling , Pending Legislation , Rulemaking Process , Salmon , USDA

FDA Releases Draft Guidance for 3D Printed Medical Devices

On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing. The draft guidance, entitled “Technical Considerations...more

5/18/2016 / 3D Printing , Cybersecurity , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices

Just as the Comment Period for “Natural” Ends, FDA Announces Intent to Re-Examine What It Means to Be a “Healthy” Food

As any company making and selling food products knows, late last year FDA requested information and comments regarding the appropriate use of the term “natural” for food – the Agency asked what types of processing make that...more

5/13/2016 / Comment Period , Food and Drug Administration (FDA) , Food Labeling , Misbranding , Natural Products

New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products....more

5/3/2016 / DQSA , Drug Compounding , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Hospitals , Outsourcing , Pharmacies

A Decade Later, Rules for the Sanitary Transportation of Food Finally Finalized by FDA

Last week, FDA finalized new food safety regulations seeking to ensure the sanitary transport of human and animal food, as required under the Food Safety Modernization Act (FSMA). The final Sanitary Transportation of Human...more

4/14/2016 / Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Sanitary Food Transportation Act (SFTA)

“Multi-Agency Interactive Tool” Available for Developers of Health Apps

It seems as though 2016 may become the year that industry receives a plethora of helpful interactive portals from Federal Agencies. My colleague Matt Cohen recently reported on the existence of a new CPSC tool called The...more

4/11/2016 / Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Health Insurance Portability and Accountability Act (HIPAA) , Mobile Apps , Mobile Health Apps , Portal

Biosimilar Developments Continue at a Rapid Pace

As our regular readers know, we’ve been tracking regulatory approvals, reimbursement policies, pharmacy substitution laws, and other developments related to biosimilar biological products. Biosimilars rely on the safety and...more

4/4/2016 / Biosimilars , Food and Drug Administration (FDA) , Health Care Providers

FDA Differentiates Biosimilar Labeling from Generic Drug Labeling

In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.” Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of...more

4/4/2016 / Biosimilars , BPCIA , Draft Guidance , Food and Drug Administration (FDA) , Labeling , Pharmaceutical Industry

Post-Senate Vote, Major Food Manufacturers Choose to Label Genetically Engineered Foods

In the wake of the Senate’s defeat of legislation that would have preempted state-mandated GE ingredient labeling on food products, a new trend is emerging, as one food manufacturer after another announces that they will...more

3/29/2016 / Food Labeling , Food Manufacturers , GMO , Legislative Agendas , Preemption

Fraudulent Dietary Supplements Highlighted in the 2016 National Consumer Protection Week

In case you hadn’t heard about it or didn’t get involved in any of the events hosted by various campaign members, the week of March 6-12 was National Consumer Protection Week. Besides the usual efforts to educate the public...more

3/18/2016 / Consumer Protection Act , Department of Justice (DOJ) , Dietary Supplements , False Advertising , Food and Drug Administration (FDA)

Mobile Health Apps Continue to Make Headlines

Recently published studies are illustrating the types of issues that mobile health application, or “app,” developers will continue to face as the industry matures alongside an evolving regulatory and enforcement landscape....more

3/16/2016 / App Developers , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Health Insurance Portability and Accountability Act (HIPAA) , Mobile Health Apps , Privacy Policy

Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to...more

3/14/2016 / Amarin , Federal Food Drug and Cosmetic Act (FFDCA) , First Amendment , Food and Drug Administration (FDA) , Misbranding , Off-Label Promotion , Pharmaceutical Industry , Preliminary Injunctions , Settlement

Agencies Engaged in Federal Biotech Overhaul to Host Final Two Public Sessions in March

After hosting the first of three stakeholder meetings late last year, federal government agencies engaged in overhauling the 1986 Coordinated Framework for the Regulation of Biotechnology recently announced that meetings two...more

2/29/2016 / Biotechnology , Environmental Protection Agency (EPA) , Food and Drug Administration (FDA) , OSTP , Public Meetings , USDA

New GE Ingredient Labeling Bill Intensifies Food Fight in Congress

The latest salvo in the legislative food fight over genetically engineered (GE) ingredients came from the Senate, where Agriculture Committee Chairman Pat Roberts (R-KS) has introduced a bill that would instruct the Secretary...more

2/29/2016 / Department of Agriculture , Food Labeling , Genetic Materials , GMO , Pending Legislation , Political Debates

Reminder – Truthful Advertising Is Not Optional

We blog frequently about new regulatory developments coming from CPSC or FDA and about enforcement actions brought by those federal agencies as well as state counterparts and private plaintiffs. But we don’t very often...more

2/12/2016 / Advertising Substantiation , Consumer Product Safety Commission (CPSC) , False Advertising , Federal Trade Commission (FTC) , FTC Act , FTC Endorsement Guidelines , Native Advertising , Unfair or Deceptive Trade Practices

First Monoclonal Antibody Biosimilar in U.S. Gets One Step Closer to FDA Approval

On February 9, 2016, the FDA’s Arthritis Advisory Committee voted 21-3 to recommend that CT-P13, Celltrion’s proposed biosimilar of Janssen Biotech, Inc.’s Remicade® (infliximab) be approved for all indications — including,...more

2/12/2016 / Amgen , Apotex , Biosimilars , BPCIA , FDA Approval , Food and Drug Administration (FDA) , Janssen Pharmaceuticals , Pharmaceutical Patents , Sandoz v Amgen

FDA Places Ban on Import of GE Salmon

Reversing course from the end of 2015, FDA recently announced an import ban on genetically engineered (GE) salmon until such a time as comprehensive labeling guidelines are introduced. Despite FDA’s approval of GE salmon in...more

2/5/2016 / Food and Drug Administration (FDA) , Food Labeling , GMO Bans , Imports , Interstate Commerce , Salmon

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...more

1/28/2016 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , HELP , Hospitals , Medical Devices , Patient Safety , Prescription Drugs

“Just Mayo” Maker Convinces FDA That a Different Label Doesn’t Have to Include a Different Name

Back in September we blogged about the Warning Letter that FDA issued to Hampton Creek Foods, Inc. for its vegan food dressing and sandwich spread, “Just Mayo” and a similar product, “Just Mayo Sriracha.” In addition to...more

1/20/2016 / Food and Drug Administration (FDA) , Food Labeling , Misleading Impressions , Warning Letters

Joanne Hawana

Mintz

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