FDA Import HoldsNew Powers to Control Products

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1 - 9999
1 - 9999
Held Sept. 24, 2013

The FDA has a new weapon in its arsenal – the ability to detain for up to 20 days drug products it believes are adulterated or misbranded, in addition to its existing import hold powers. And, it’s working closer than ever with Customs and Border Protection and the USDA to stop bad shipments.

Customs officials don’t care that your shipment may be perishable and deteriorating by the minute. If the supplier has been tagged in the PREDICT system the product has been identified as adulterated, your shipment can be stopped cold.

To bring you up to date on these new powers, the status of the PREDICT system, the new PLAIR guidance and the proposed Qualified Trusted Importer Program, FDAnews has brought together a top-notch team to teach you the following:

  • Best practices for getting pre-admission decision before your product reaches the border
  • What the most common problems are with labeling
  • Details on the Qualified Trusted Import program
  • How the PREDICT system has been working post-rollout
  • Six ways to best communicate with FDA staff to keep your shipment moving towards its delivery goal

In just one fast-paced day, you’ll hear from…

  • Benjamin England, Founder and CEO, Benjamin L. England & Associates, LLC & FDAImports.com LLC. Ben is a 17 year veteran of the FDA. Among other things, he worked as program manager for PREDICT and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs.
  • Michael Mullen, Executive Director, Express Association of America.  Mike frequently meets with FDA officials to help improve importation issues.  Most recently, he met with Melinda Plaiser, Acting Associate Commissioner, regarding recommendations on FDA import entry admissibility decisions.
  • William Nychis, Senior Regulatory Advisor, FDAimports.com.  William has nearly 40 years of experience at FDA.  He drafted numerous guidance documents, import alerts and policy documents for FDA.
  • Jim Johnson, Pharmaceutical and Life Sciences Group, Hogan Lovells; formerly Associate Chief Counsel, Office of the Chief Counsel, FDA.  Jim has been on both sides of import holds – enforcing them on behalf of the FDA and successfully getting clients’ products released from them.

This virtual conference CD and transcript set, sponsored by FDAnews, features top experts who have been in the import holds trenches. Without ever leaving the comfort of your office, you’ll gain practical knowledge that helps you assure your valuable product makes it from supplier to your loading dock without problems.

For drug, device, biologics and diagnostics companies that deal with overseas suppliers, this CD and transcript set couldn’t be timelier.

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10:00 a.m. – 10:15 a.m.

Introduction to the Virtual Conference

10:15 a.m. – 11:15 a.m.

The New Enforcement Posture: PREDICT, PLAIR, Customs and 2013 FDA Trends
Get the inside track on the emerging powers of the FDA for enforcement, screening and inspections in light of new legislation and trends. Understand the impact of PREDICT, risk data, statistics, processes and the trends affecting manufacturers, importers and distributors this year. Understand the trends, understand the FDA, and solidify your strategies.

Attendees will learn:

  • What is PREDICT and how does it affect me?
  • What PLAIR could do to change import holds
  • FDA importation authorities and processes — what’s changing and what’s staying the same?
  • What trends are the FDA and Customs focusing on today that could get you in hot water?
  • Understanding the thresholds and severity of the new enforcement powers at play

Benjamin England, Founder & CEO, Benjamin L. England & Associates LLC and FDAImports.com

11:15 a.m. – 11:30 a.m.


11:30 a.m. – 12:30 p.m.

Certified Importer Approach: Better than Transactional Controls —Assessing the Potential for Integrated Border Management Between the FDA, Customs and USDA
Currently the FDA, Customs and USDA operate independently of each other with regards to approving goods entering the U.S. This process is very complex and is subjected to each import transaction, which can cause undue delays at the border. An integrated border management framework, where the various agencies work in concert with each other, can allow a drug to be pre-approved for distribution and help to streamline the process of crossing the border. A promising initiative, the Qualified Trusted Importer Program (QTIP), would assess a company’s internal processes and controls with respect to product quality, supply chain security and trade compliance. Upon review, companies that qualify as “trusted importers” would be afforded interagency
green-lane status. Not only would this allow a company to receive a pre-admission decision from the FDA, Customs and USDA, but it would also prevent a company from having to go through a lengthy process for each transaction. For a company that imports on a large scale, it would be a significant savings of time and resources. This session discusses the potential benefits of an integrated border management program.

Attendees will learn:

  • How to apply risk management techniques to ensure compliance
  • Details on the Advocate for Qualified Trusted Import Program (QTIP)
  • Benefits of an account management rather than transaction system
  • What’s “green-lane” status?
  • Best practices for achieving pre-admission decisions prior to reaching the border

Michael Mullen, Executive Director, Express Association of America

12:30 p.m. – 1:30 p.m.


1:30 p.m. – 2:30 p.m.

FDA Imports: Surviving an FDA Import Hold Crisis
Regardless of the reason, once a shipment is held at an entry point, the shipment’s owner has the right to a single, informal hearing.  Should the owner be unable to prove to the FDA’s satisfaction that the product meets all requirements, it will be forced to export or destroy the shipment.  Should this exportation or destruction not occur within 90 days of the hearing’s conclusion, Customs can seek to fine the owner three times the detained product’s worth.  Plus, the loss of revenue from a single shipment could represent millions in lost profits. This session will provide guidance on how to negotiate hold releases, when to bring in outside help, and what to do to prepare for the informal hearing.

Attendees will learn:

  • 6 techniques for communicating with FDA personnel—slow communication and miscommunications are lethal when the clock is running on your shipments.
  • How to understand and comply with documentation requirements—not having your paperwork in order is a surefire way to have your import held 
  • The levels of import holds and the likelihood of a successful challenge at each
  • Import alerts—how to prevent the death penalty for your shipments and how to negotiate with the FDA once it is imposed
  • How the PREDICT system will influence the import alert and hold process
  • Best practices to assure your PREDICT profile doesn’t raise red flags with the FDA

William Nychis, Senior Regulatory Advisor, Benjamin L. England & Associates

2:30 p.m. – 2:45 p.m.


2:45 p.m. – 3:45 p.m.

How to Review Product Labeling to Avoid FDA Import Compliance Woes — 5 Steps You Need to Take
Incorrect or confusing labeling is a key reason why many products face import holds.  The authority to hold product is based upon the “appearance” of a violation, so proper labeling is critically important.  This presentation will help firms understand that no matter what the product is (API, OEM, finished goods) or who it’s being imported from (partner, sister company, supplier) the labeling needs to be accurate to assure smooth entry.

Attendees will learn:

  • The most common problems with labeling that raise red flags for Customs and FDA staff
  • 5 steps you can take to reduce any appearance of violation

Jim Johnson, Pharmaceutical and Life Sciences Group, Hogan Lovells

3:45 p.m. – 4:00 p.m.

Closing Comments and Adjournment

Drug, device, biologics or diagnostics, every FDA-regulated company that deals with offshore importers is a candidate for participation. It’s ideal for:

  • Compliance officers
  • Executive management
  • Supply chain managers
  • Warehouse/shipping managers/supervisors
  • Consultants/service providers involved in imports
  • General/corporate counsel
  • Manufacturing directors and supervisors to the extent manufacturing aspects involve imported material
  • Regulatory/legislative affairs professionals

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600