Responding to FDA Investigation
Requests
John Manthei, Partner, Latham & Watkins LLP
Gary Messplay, Partner, Hunton & Williams LLP
Enforcement
Litigation and
Compliance
Washington, DC
December 9-10, 2015
Mark Levy, Member, Eckert Seamans Cherin & Mellott, LLC
Moderated by Kay Holcombe, Science Vice President, Science
Policy, Biotechnology Industry Organization
Agenda
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Introductions
Overview of FDA Requests for Information
Case Study
Initial Steps in Responding
Collection of Documents and Conducting Interviews
FDA’s Authority to Request Information
Company’s Obligation to Produce Information
Other Considerations
Privilege and Attorney Work Product Doctrine
Who Should Lead Investigation
FDA Actions Following Company Response
Q&A
Wrap Up
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Responding to FDA
Investigation Requests
Gary Messplay, Hunton & Williams LLP
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Overview of FDA Requests for Information
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FDA letters to sponsors requesting information seem to be
on the rise
Many of these letters are being sent by CDER’s Office of
Prescription Drug Promotion (OPDP)
Letters typically identify facts of which FDA has become
aware and then ask numerous detailed questions seeking
information
Responses are generally requested within 14 days
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Case Study
“The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and
Drug Administration has become aware that Madrigal Pharmaceuticals,
Inc. (Madrigal) may be promoting their drug Ortega in violation of the
Federal Food, Drug, and Cosmetic Act and its implementing regulations.
Specifically, we refer to the following:
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Dr. Jesse Pinkman – A New Cerebral Palsy Solution” website available at
www.anewcerebralpalsysolution.com/.
Pinkman, J. (2014). A New Cerebral Palsy Solution. New York, NY; Los
Pollos Hermanos Press.
“The Clinical Implications of Cerebral Palsy.” Symposium presented at the
2015 American Academy of Neurology (AAN). Albuquerque, NM (the
“symposium”).
“Cerebral Palsy Treatment Breakthrough,” television segment on KKOB,
Albuquerque, NM. June 6, 2015, 6:45 AM PDT.
5
Case Study (cont’d)
In order to aid in our determination of Madrigal’s possible involvement with
the above communications, we request that Madrigal provide the
information below.
1.A complete description of the relationship between Madrigal and Dr. Jesse
Pinkman. This includes any corporate, financial, employment, consultancy,
research, or marketing relationships, and all current and past agreements,
contracts, compensations, gifts, or gratuities. Please indicate whether Dr. Pinkman
disclosed his relationship with Madrigal to AAN and, if so, the timing and content of
the disclosure. Also, please disclose any relationship between Dr. Pinkman and
Madrigal during the development and publication of the book A New Cerebral Palsy
Solution.
2.A complete description of Madrigal’s involvement with, or influence on, the
initiation, preparation, development, and publication of each of the above
communications. This includes background materials, talking points, slides,
speaker’s notes, questions or answers, instructions, drafts, outlines, etc.
6
Case Study (cont’d)
3.
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A complete description of any off-label uses for Ortega that were discussed during the
above communications and whether any disclosures were provided regarding these off-label
uses.
A complete description of any contact that Madrigal had with other parties involved in the
creating, producing or disseminating the above communications, the nature of the contact
and the substance of the discussions.
Please identify each use or dissemination of the above communications and of other similar
communications, including dates, locations, recipients, circumstances, and the parties
responsible for the distribution, including employees and vendors of Madrigal.
For each communication in question 5, provide a complete description of Madrigal’s
involvement with, influence on, or knowledge of the recipients and parties responsible for
distribution of information about the communications.
A complete description of Madrigal’s involvement over and support of other CME programs
that have discussed Ortega.
A complete description of Madrigal’s involvement with the promotion of Ortega in a similar
manner.
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Case Study (cont’d)
We request that you submit a written response to OPDP within 14 days. We remind you that only
written communications are considered official.
Sincerely,
{See appended electronic signature page}
Sklyer White, Pharm.D.
Regulatory Review Officer
Office of Prescription Drug Product
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What Initial Steps Should Company Take?
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Determine who will be responsible for investigating, collecting
relevant information, and preparing response
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A team likely will be needed
What resources will be required
Is 14 days realistic or should extension of time be requested
Contacts with third parties, including Dr. Pinkman
Collection of documents
Interviews
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FDLI: Enforcement, Litigation,
and Compliance
Responding to FDA Investigation Requests
John Manthei
Latham & Watkins LLP
December 10, 2015
FDA Authority to Request Information
• FDA does not have administrative subpoena power.
• However, under 21 U.S.C. §374(a), FDA’s inspection of:
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“any
factory, warehouse, establishment, or consulting laboratory”;
– in which prescription drugs or non-prescription drugs are “manufactured,
processed, packed, or held”;
– may extend to all things therein “including records, files, [and] papers”
which bear on whether adulterated or misbranded products (or products
which otherwise may not be manufactured, introduced into interstate
commerce, or sold or offered for sale) have been or are being
“manufactured, processed, packed, transported, or held in any such
place, or otherwise bearing on violation of this chapter”
FDA Authority to Request Information
• Moreover, any records or other information that FDA may inspect
from a person who owns or operates an establishment engaged in
the manufacture, preparation, propagation, compounding or
processing of a drug shall, upon FDA’s request, be provided to FDA:
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“in advance of or in lieu of an inspection,
within a reasonable timeframe,
within reasonable limits,
and in a reasonable manner,
and in either electronic or physical form,
at the expense of such person.”
FDA Authority to Request Information
• This authority excludes:
– financial data and pricing data;
– sales data (other than shipment data);
– personnel data (other than data regarding the qualification of certain
technical and professional personnel); and
– research data (other than data relating to new drugs and antibiotic drugs
subject to reporting and inspection under FDA’s regulations).
• Regarding inspections generally, FDA has long maintained that it
needs no warrant or consent to inspect a regulated company; courts
have supported this principle, holding that FDA-regulated industries
are “closely regulated” and therefore no warrant is needed.
Obligation to Comply
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The FDCA identifies “the refusal to permit access to or copying of any record
as required by [21 USC §374(a)]” as a prohibited act.
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Any person who commits such an act “shall be imprisoned for not more than
one year or fined not more than $1,000, or both,” or if the person previously
committed a prohibited act, or has acted with an intent to defraud or mislead,
“such person shall be imprisoned for not more than three years or fined not
more than $10,000, or both” (21 USC §333).
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Title 18 of the U.S. Code raises these values to $100,000 for most
misdemeanors and $250,000 for most felonies (for individuals), or $200,000
and $500,000 (for organizations).
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FDA may seek enforcement through the federal courts and/or in conjunction
with the Department of Justice.
Other Considerations
• It is critical to ensure that the correct team is in place to assess and
respond to FDA’s request.
– At minimum: management, internal/external counsel, Regulatory Affairs
and QA teams.
– Be mindful of the specific matter implicated, as this will influence who to
include in the team.
• Information turned over to FDA may subsequently be discoverable in
a civil suit, such as a class action or securities matters (a common
plaintiff’s tactic is to request all possible materials under the sun).
Other Considerations
• Companies should proactively establish a process to protect
materials under the attorney-client privilege.
– Attorney-Client Privilege: A legal privilege to refuse to disclose
confidential communications between a client and his/her attorney.
– Attorney Work Product: Written or oral materials prepared by or for an
attorney in the course of legal representation, which an opposing party
generally may not discover or compel to be disclosed.
• FDA cannot access materials protected by the privilege.
– However, privileged materials might demonstrate that companies are in
compliance with FDA requirements. In this case, companies should
carefully weigh whether or not to turn such materials over to FDA.
When Such Considerations May Arise
• Contexts in which FDA might request information include (among
others):
– In follow up to an adverse event;
– After the release of new information in a journal or published study;
– In connection with other investigational observations.
• Tricky scenarios may arise.
– Example: FDA may request scientific data where not strictly required,
such as regarding an OTC product marketed under a monograph. The
company may be willing to provide the data to FDA, however a separate
and ongoing class action suit complicates the decision to turn the data
over.
FDLI ENFORCEMENT, LITIGATION
AND COMPLIANCE CONFERENCE
Responding to FDA Investigation
Requests
DECEMBER 10, 2015
Presented by: Mark C. Levy, Esquire
Eckert Seamans Cherin & Mellott, LLC
Board Oversight Role—
Reporting Obligations
• High-Stakes, High-Profile: Board plays active
role. Separate committee assigned to
oversight and review.
• Serious: Board actively monitors internal
investigation and may become more involved
if facts dictate.
• Routine: Board monitors on quarterly basis
and any significant investigations.
Investigation Risks
• Protect attorney-client privilege and maintain confidentiality in appropriate
cases, and attorney work product considerations.
Attorney-Client Privilege
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In order to establish the attorney-client communication privilege, there must
be a:
Communication
between a Lawyer
and Client
that was Confidential
and remained Confidential
for the purpose of seeking or giving Legal Advice, not business advice.
Attorney Work Product
• Material prepared or mental impressions developed in anticipation of
litigation or for trial by a party or a party’s representatives, including the
party’s attorneys, employees, or agents; or
• a communication made in anticipation of litigation or for trial between a party
and the party’s representatives or among a party’s representatives, including
the party’s attorneys, consultants, employees or agents.
Protecting the Privilege
• Serious investigations often require preservation of privilege.
• Routine investigations often do not require preservation of privilege.
• Dangers for waivers or failure to protect
– Risk from non-legal related communications: Public relations participation
• Discussion and disclosure for purposes other than providing legal advice and
counsel
Documents
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Issue broad HOLD LETTER in Serious
– Instruct parties to suspend document retention
policy and collect all relevant documents.
– INVOLVE Information Technology quickly.
Proceed Carefully:
– PRESERVE PRIVILEGE: Protect by noting as
such.
Upjohn Warnings to Witness
• Purpose of Upjohn Warnings: Preserves Ability to Use Statement Against
Witness (e.g. hand over to government or use against witness in civil
litigation).
• Nature and purpose of interview
• Attorney does not represent the employee.
– What if employee asks if he or she needs a lawyer? Or lose his or her
job?
• Company holds and decides on attorney-client privilege and decides when
and if to disclose.
Upjohn Warnings to Witness
• The so-called Upjohn warning takes its name from the seminal Supreme
Court case Upjohn Co. v. United States, in which the court held that
communications between company counsel and employees of the company
are privileged, but the privilege is owned by the company and not the
individual employee. Upjohn Co. v. United States, 449 U.S. 383 (1981).
Lauren Stevens case.
• Letter inquiry from FDA about marketing and off-label promotion related to
Wellbutrin.
– Voluntary response to informal inquiry.
• In-house counsel works with outside counsel to respond, but executes letter
on behalf of company.
– States that will be able to “obtain and provide to [FDA] materials and
documents presented at GSK-sponsored promotional programs….”
Lauren Stevens case.
• Eight years after letter inquiry, Steven charged with obstruction of justice in
responding to FDA letter.
– Government asserts that she lied to FDA.
– Judge allows review of attorney-client privileged documents under crimefraud exception.
• Judge Titus dismisses case saying that it should never have been
prosecuted.
– Acted upon advise of counsel.
– Attorney-client privilege should never have been vitiated.
Challenges to privilege—
other cases
• In re Kellogg Brown & Root, Inc., 756 F. 3d 754 (D.C. Cir. 2014), cert.
denied, 135 S. Ct. 1163 (2015).
– Federal district concludes that government contractor must disclose
documents related to internal investigation conducted by in-house legal
department. 37 F. Supp. 3d 1 (D. D.C. 2014). Court concludes that
investigation conducted as part of its compliance obligations as a
government contractor, so not protected by privilege or work product
doctrine. Court applies “but for” test to determine primary purpose is to
obtain legal advice.
Challenges to privilege–
other cases
– D.C. Circuit reverses on mandamus petition. The attorney client privilege
applies so long as “one of the significant purposes…was to obtain or
provide legal advice.” Court also held that, the fact company used inhouse counsel and their “agents” (investigators), was not material to
privilege issue.
KBR, Wal-Mart and Penn State
• District court, on remand, circumscribed the ruling refusing to give it blanket
application: this includes waiver, inapplicability to specific documents under
federal discovery rules.
• D.C. Circuit again concludes that the district court was not correct in its
application of the law. In re KBR, No. 14-5319, *2 (D.C. Cir. Aug. 11, 2015).
KBR, Wal-Mart and Penn State
• Delaware Supreme Court grants shareholder access to
privileged documents from a related internal
investigation. Wal-Mart Stores, Inc. v. Ind. Elec.
Workers Pension Trust IBEW, 95 A. 3d 1264 (Del.
2014).
– Shareholder derivative action.
– Court compels disclosure under “good cause”
exception to corporation’s assertion of attorney-client
privilege to preliminary investigation conducted by
general counsel. The general counsel was a target
of the investigation and the investigation protocol was
“modified”—and, he cleared himself and other
executives of wrongdoing.
KBR, Wal-Mart and Penn State
• In the wake of the Jerry Sandusky scandal, Penn State retained a law firm to
conduct an internal investigation relating to Sandusky’s conduct as well as
that of the university in responding.
– State court rules that law firm not retained to provide “legal services” and
thus communications between law firm and Penn State not subject to
attorney-client privilege. Paterno v. NCAA, No. 2013-2082 (Pa. Ct. Com.
Pl. Jan. 7, 2014).
KBR, Wal-Mart and Penn State
• Firm hired by Board of Directors and firm retained related consulting
group to provide “legal services” to the firm.
• Firm provides updates to NCAA during investigation.
• Estate of Joe Paterno seeks investigative documents related to
creation of “Freeh Report” in subsequent civil litigation.
KBR, Wal-Mart and Penn State
– Court finds that engagement letter not satisfactory to conclude that
retained to secure a legal opinion and also, a selective waiver by
disclosure to public (in report) and by providing documents to NCAA.
– Various issues still being litigated. See, e.g., In Re: Application by
Nonprofit Corporation Trustees to Compel Inspection of Corporate
Information, No. 1593 for 2015 (Ct. Comm. Pl. Centre Cty. Nov. 19,
2015) (ordering production of, but limited use of, allegedly privileged
materials (“source material”) after appropriate designation).
Lessons Learned
• Exercise caution in how internal investigations are
conducted.
• Distinguish between routine and high risk, high profile
investigations.
• Think carefully about who performs the investigation and
to whom they report.
• Better understand the applicable attorney-client privilege
and work product doctrines.
– For legal purposes—threat of litigation.
– Attorney oversight.
– Upjohn warnings.
– Mark documents accordingly.
Questions?
Mark C. Levy, Esquire
Eckert Seamans Cherin & Mellott, LLC
Two Liberty Place, 50 S. 16th Street, 22nd Floor
Philadelphia, PA 19102
(215) 851-8404 | mlevy@eckertseamans.com