FDA Enforcement against Imports

John Johnson IIIAssociate Attorney,Benjamin L. England & Associates, LLC& FDAImports.com, LLC

FDA Import Enforcement Authority: Section 801(a)

The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or section 387e(h) of this title and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 360j(f) of this title, or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 355 of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title, or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article, then such article shall be refused admission, except as provided in subsection (b) of this section. With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission. If such article is subject to a requirement under section 379aa or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 379aa or 379aa–1 of this title) has not complied with a requirement of such section 379aa or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 379aa or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. Clause (2) of the third sentence of this paragraph  1 shall not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled Substances Import and Export Act.

FDA Import Enforcement Authority: Section 801(a) - Summarized

• Examine any food, drug, cosmetic, device, or tobacco product

• Refuse admission to any article that appears to violate

• Import alerts to ease enforcement the Act

Total Shrimp Refusals (January through October)

Common Charges Shrimp Refusals

Salmonella Refusals

Vet. Drug Refusals

Additional Reflections

• Singular Approach?

• Essentially no overlap between vet. drugs and Salmonella refusals

• Reliance on the Import Alert System

• Vast majority of refusals are not based on FDA testing

The draft EU medical device regulations and enhanced GMP surveillance by Notified Bodies and Competent Authorities.

The Impact on US medical device manufacturers

Phil Johnson, Senior Director

Regulatory, Quality and Compliance

Quintiles Consulting

FDLI Enforcement, Litigation and Compliance Conference

December 8 - 9, 2014, Washington, DC

Summary

• The upcoming changes in GMP requirements being proposed in the draft EU Medical Device Regulation

• Increased compliance requirements for Notified Bodies and their continued certification by EU Competent Authorities

• Increase in the suspension of EC Certificates for US manufacturers and the compliance and fiscal repercussions of losing these certificates and loss of ISO13485:2003 (GMP) certificates

• What can US manufacturers do now to mitigate this increased surveillance by EU Competent Authorities and Notified Bodies

10

EU Regulatory environment is changing

11

The 3 device Directives (AIMDD, MDD, IVDMDD) will become 2 Regulations Regulations are directly applicable in Member States The Medical Device Regulation and the IVD Regulation will be accompanied by other

Implementing Regulations such as UDI and additional post-market requirements. The EU landscape will change over the next few years. Some of the key changes are:

Increased clinical evidence requirements More rigorous Notified Body

assessment and unannounced audits of manufacturers and crucial suppliers

New and increased obligations for economic operators in the supply chain

(ARs, distributors and importers)Unique Device Identification

Changes to post-market surveillance requirements

Requirement for Qualified Person

Pre-market authorisation of high-risk medical devices

Increased focus on vigilance, with closer authority cooperation, and a central EU

vigilance portal

EU Regulatory environment is changing

12

COMMISSION RECOMMENDATION

(2013/473/EU)of 24 September 2013 on

the audits and assessments performed by notified bodiesin the field of medical devices

How Notified Bodies audit Manufacturers

COMMISSION REGULATION (EU) No 920/2013

of 24 September 2013 on

the designation and the supervision of notified bodies

under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices

How Competent Authorities control Notified Bodies

EU Regulatory environment is changing

13

– Unannounced visits to the manufacturer and critical subcontractor/supplier at least once in every three years

– Manufacturer continuously informs Notified Body when not manufacturing  - so NB knows when to come. Contract terminates when manufacturer can no longer assure access to the manufacture or critical subcontractor/supplier. Contract with critical subcontractor/supplier to allow NB unannounced visits and continuously inform when not manufacturing

– Device testing by NB at a test lab or at the manufacturer’s site

– Product assessments for design dossiers/type exam - greater depth, including design, manufacture, labelling, packaging, risk management, clinical data/performance evaluation, post market plan/follow up, technical file up to date and aligned with certificate scope

– Quality system assessments (Full, production and product QA) - greater depth , including technical file sample of all types over 5 years, quality system elements. Product identification traced to devices on NB certificate, declaration of conformity, technical file and manufacturing process

– Increased audit days and NB costs

– Contract between manufacture and NB to reflect these changes

14

Commission Recommendation 2013/473/EU

Jennifer R. Diaz, Shareholder

Board Certified in International Law

Chair, Customs and International

Trade Department

Becker & Poliakoff Law Firm

(305) 260-1053

(305) 724-3281 (cell)

JDiaz@bplegal.com

International Enforcement and Compliance Initiatives

FDLI Enforcement, Litigation & Compliance Conference December 8, 2014

DISCLAIMER

• This presentation is for informational purposes only and does not purport to provide legal advice as all cases and facts are different.

• The information in this presentation is provided “as is” and no representations are made whatsoever.

• You should not rely on the information included in this presentation as an alternative to legal advice from your attorney.

• For questions related to a specific matter, you should consult your attorney.

• To the extent permitted by law, this presentation is Copyright © 2014 by Becker & Poliakoff, P.A.

• Expediting your supply chain– Interplay Between CBP and

FDA• Future of C-TPAT

• NEW Trusted Trader Pilot Program

– NEW Benefits

• Top rationales for FDA detentions upon Importation

DHS is responsible for:

• Managing the nation's borders and ports-of-entry.

– Preventing the passage of individuals or goods from entering the United States unlawfully.

– Working overseas to strengthen U.S. defenses against illegal smuggling and immigration.

• DHS includes the U.S. Customs and Border Protection (CBP) which is the single, unified border agency of the United States Government.

– CBP and is responsible for border security—including antiterrorism, immigration, anti-smuggling, trade compliance, and agriculture protection—while simultaneously facilitating the lawful trade and travel at U.S. ports of entry that is critical to our Nation’s economy.

CUSTOMS TRADE PARTNERSHIP AGAINST TERRORISM

• Voluntary government-business initiative - 2002.

• Goal: strengthen and improve overall international supply chain security, U.S. border security and minimize the threat of terrorism in the U.S.

• Private companies submit to CBP a company profile and security profile including proof that certain security measures have been made to prevent terrorists or terrorist weapons from attempting to enter the U.S.

• Customs “certifies” membership of the applicant as a C-TPAT member.

Customs-Trade Partnership Against Terrorism (C-TPAT)

• Currently over 10,756 participants

• Businesses eligible to apply for C–TPAT membership include:– U.S. importers of record;– Mexican and Canadian

manufacturers;– Licensed U.S. customs

brokers;– U.S. marine port

authority/terminal operators;

– Carriers… and more

• C–TPAT incentives are based on 3 tier structure.– Tier I to importer partners

that have been certified;– Tier II to certified AND

validated – Tier III to importers who

have exceeded the program’s requirements• 334

– 2013 2131 total validations conducted

C-TPAT• Reduced frequency of examinations and time in cargo

secondary inspection lines.– Tier III C-TPAT partners are 9 times LESS likely to undergo a

security based examination

– Tier II C-TPAT partners are 3.5 times LESS likely

• Reduced time and cost of getting goods released.

• Point of contact person assigned by CBP specifically to company (SCSS).

• Reduced penalties.

• Improved security for workforce.

• Viewed as better citizen in the trade community (marketability and mutual recognition).

Importer Self Assessment (ISA)• A voluntary approach to trade compliance• Open to US and Canadian importers• The ISA program is a trade facilitation partnership

between CBP and importers• Highly compliant importers who have made a

commitment to comply with Customs laws and regulations in exchange for benefits.

• A voluntary approach to trade compliance that allows importers to maximum control of their own CBP compliance.

• Recognizes importers who are willing to assume responsibilities for self-assessment in exchange for less CBP oversight.

• After initial CBP review by Auditors, importers are responsible for monitoring their own compliance and reporting any errors to CBP.

• Benefits include removal from the audit universe and enhanced prior disclosure benefits.

• ISA participants must also be C-TPAT certified (security partnership).

ISA

• Exemption from comprehensive audits• Less CBP Intrusion• Coverage for multiple business unites• Greater business certainty• Enhanced prior disclosure• Participation can be considered mitigating factor

for penalties or liquidated damages• National account manager

Trusted Trader Program

Trusted Trader Program• CBP, FDA, & CPSC are working together!• In Pilot stage now • Will replace ISA (but, not C-TPAT)

• Additional incentives (above C-TPAT & ISA):– Reduced FDA targeting/examination risk score– Penalty offsets– Reduced FTZ inspections– Exempt from random non-intrusive Inspections– Choice of exam locations (other than port of arrival)– Release of merchandise no subject to further

examination– CPCS benefits (including a point of contact)– AND MORE…

MULTIPLE PORTS OF ENTRY? CEE

CEE Locations

TOP FDA ISSUES for FOOD PRODUCTS/ DIETARY

SUPPLEMENTS*

• Non-Compliant Labeling* Manufacturer failure to register – FDA (www.FDA-USA.com)

• No registration for Low Acid Canned Foods

• Subject to Import Alert*

TOP FDA ISSUES forCOSMETICS/DRUGS*

• Non-compliant labeling*

• Subject to import alert*

• Non-permitted color additive

• Contaminated and unsafe

• Manufactured in unsanitary conditions (GMP’s)

TOP FDA ISSUES for

MEDICAL DEVICES• The manufacturer and/or

initial importer is not registered with the FDA

• The device is not listed with the FDA

• The product does not contain 510k clearance or PMA

• Assure CORRECT affirmation of compliance codes used in PREDICT

• Product labeling is not compliant

Do you have questions about importing and exporting?

Visit and subscribe to my blog at

www.customsandinternationaltradelaw.com

Now That We Have Our Paws Dirty… Any Questions?

Jennifer R. Diaz, Shareholder

Board Certified in International Law

Chair, Customs and International

Trade Department

Becker & Poliakoff Law Firm

(305) 260-1053

(305) 724-3281 (cell)

JDiaz@bplegal.com

International Enforcement and Compliance Initiatives

FDLI Enforcement, Litigation & Compliance Conference December 8, 2014

The draft EU medical device regulations and enhanced GMP surveillance by Notified Bodies and Competent Authorities.

The Impact on US medical device manufacturers

Phil Johnson, Senior Director

Regulatory, Quality and Compliance

Quintiles Consulting

FDLI Enforcement, Litigation and Compliance Conference

December 8 - 9, 2014, Washington, DC

Summary

• The upcoming changes in GMP requirements being proposed in the draft EU Medical Device Regulation

• Increased compliance requirements for Notified Bodies and their continued certification by EU Competent Authorities

• Increase in the suspension of EC Certificates for US manufacturers and the compliance and fiscal repercussions of losing these certificates and loss of ISO13485:2003 (GMP) certificates

• What can US manufacturers do now to mitigate this increased surveillance by EU Competent Authorities and Notified Bodies

35

EU Regulatory environment is changing

36

The 3 device Directives (AIMDD, MDD, IVDMDD) will become 2 Regulations Regulations are directly applicable in Member States The Medical Device Regulation and the IVD Regulation will be accompanied by other

Implementing Regulations such as UDI and additional post-market requirements. The EU landscape will change over the next few years. Some of the key changes are:

Increased clinical evidence requirements More rigorous Notified Body

assessment and unannounced audits of manufacturers and crucial suppliers

New and increased obligations for economic operators in the supply chain

(ARs, distributors and importers)Unique Device Identification

Changes to post-market surveillance requirements

Requirement for Qualified Person

Pre-market authorisation of high-risk medical devices

Increased focus on vigilance, with closer authority cooperation, and a central EU

vigilance portal

EU Regulatory environment is changing

37

COMMISSION RECOMMENDATION

(2013/473/EU)of 24 September 2013 on

the audits and assessments performed by notified bodiesin the field of medical devices

How Notified Bodies audit Manufacturers

COMMISSION REGULATION (EU) No 920/2013

of 24 September 2013 on

the designation and the supervision of notified bodies

under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices

How Competent Authorities control Notified Bodies

EU Regulatory environment is changing

38

– Unannounced visits to the manufacturer and critical subcontractor/supplier at least once in every three years

– Manufacturer continuously informs Notified Body when not manufacturing  - so NB knows when to come. Contract terminates when manufacturer can no longer assure access to the manufacture or critical subcontractor/supplier. Contract with critical subcontractor/supplier to allow NB unannounced visits and continuously inform when not manufacturing

– Device testing by NB at a test lab or at the manufacturer’s site

– Product assessments for design dossiers/type exam - greater depth, including design, manufacture, labelling, packaging, risk management, clinical data/performance evaluation, post market plan/follow up, technical file up to date and aligned with certificate scope

– Quality system assessments (Full, production and product QA) - greater depth , including technical file sample of all types over 5 years, quality system elements. Product identification traced to devices on NB certificate, declaration of conformity, technical file and manufacturing process

– Increased audit days and NB costs

– Contract between manufacture and NB to reflect these changes

39

Commission Recommendation 2013/473/EU

EC Certificate Withdrawals % issued

The European Association Medical devices – Notified Bodies, Team NB: Survey 2012 http://www.team-nb.org/documents/2013/TEAM-NB-MD-2012-Survey.pptx

Notified Body Audit Results

40

EC Certificate ISO 13485:2003 Certificate

•Would deny a manufacturer access to market in all the EEA Member States

•Brings concern and attention from other Regulatory Authorities

•Australia, Saudi Arabia, China and other countries have a simpler registration process if devices are approved in the EU. Withdrawal of an EC Certificate may affect registration in other countries

•Impact on maintaining EC Certificate where full quality assurance is required

•Deny access to Brazil and Canada and other countries where ISO13485 is mandated

•Health Authority tenders for devices require ISO13485 to complete contracting

Impact of EC Certificate/ISO13485 withdrawal

41

Impact on US Medical Device Manufacturers

42

What US manufacturers can do now

Review and understand Commission Recommendation 2013/473/EU and inform all stakeholders of the impact

Start preparing for Notified Body unannounced audits and review contracts with critical suppliers

Draft processes / procedures for receiving Notified Bodies (base it on existing FDA practices)

Review critical subcontractors and crucial supplier contracts, amend for unannounced audits Check readiness of sub-contractors to react to unannounced audits (mock audits)

Plan now for any product reviews by your NB. Lead times will be longer and reviews will be more exhaustive. Good technical files will speed the process

Factor additional visit costs in to budget processes, including any critical suppliers . Clarify the needs with your NB now

43

Questions?

11