Slides - Food and Drug Law Institute

Presented by:
Mark C. Levy, Esquire
December 8-9, 2014
First Amendment—Post Caronia
United States v. Caronia, 09-5006-CR (2d Cir.
December 3, 2012.
Not appealed to the Supreme Court.
“While the FDCA makes it a crime to misbrand or
conspire to misbrand a drug, the statute and its
accompanying regulations do not expressly
prohibit or criminalize off-label promotion.”
First Amendment—Post Caronia
“we construe the FDCA as not criminalizing
the simple promotion of a drug's off-label use
because such a construction would raise First
Amendment concerns. Because we conclude
from the record in this case that the
government prosecuted Caronia for mere offlabel promotion and the district court
instructed the jury that it could convict on that
theory, we vacate the judgment of conviction.”
First Amendment—Post Caronia
We decline to adopt the government's
construction of the FDCA's misbranding
provisions to prohibit manufacturer promotion
alone as it would unconstitutionally restrict
free speech. We construe the misbranding
provisions of the FDCA as not prohibiting and
criminalizing the truthful off-label promotion of
FDA-approved prescription drugs.
First Amendment—Post Caronia
We conclude simply that the government cannot
prosecute pharmaceutical manufacturers and
their representatives under the FDCA for speech
promoting the lawful, off-label use of an FDAapproved drug.
Post-Caronia—United States v. Vascular
Solutions Inc. (W.D. Tex.) (Nov. 14, 2014)-indictment alleging conspiracy to defraud U.S.
government, along with distributing adulterated
and misbranded medical devices.
First Amendment—Post Caronia—The
False Claims Act
Statement of interest by the government:
United States of America ex rel. Matthew Cestra
et al. v. Cephalon, Inc., et al., S.D.N.Y., 10 Civ.
6457 (SHS) (case transferred to E.D. PA., 08-cv00287-TON) and captioned United States of
America ex. rel. Bruce Boise, et al. v. Cephalon,
Inc., et al.
Recovery of 3.8 billion in 2013 under FCA.
Qui Tam—2.9b. Relators share: $345m. 752
filed in 2013.
FDCA cases, criminal fines—1.3b.
First Amendment—Post Caronia
In responding to a motion to dismiss under Rule
9(b) in non intervened case:
The FCA does not prohibit off-label promotion ..;
rather the FCA prohibits conduct that causes the
submission of false claims to the Government for
“…the central question is whether the defendant’s
marketing caused the submission of false claims, i.e.,
claims for off-label uses that are not covered or
reimbursable by federal health care programs.”
The FCA does not prohibit speech; rather it is a
remedy for actions that cause a false claim
First Amendment—Post Caronia
United States of America, ex. Rel. Frank Solis
v. Millennium Pharmaceuticals, Inc., ScheringPlough Corp., and Merck & Co., U.S.D.C.,
E.D. Ca., 2:09-CV-3010-MCE-JFM.
Amicus Brief of PhRMa—no allegation that
speech allegedly giving rise to false claim was
false or misleading. Rather, distribution of
reprints of medical studies from reputable journals
regarding off label use.
First Amendment—Post Caronia
Government response: Does not matter whether
true or false as it is prompting submission for
reimbursement ineligible for payment.
Phrma—First Amendment demands a direct
causal nexus between speech and claim. The
speech at issue in Solis does not urge or instruct
others to submit false claims.
Sets the table for another legal battle over the
implication of free speech in the context of
pharmaceutical marketing.
New DOJ Policy on Qui Tam Review
Leslie Caldwell, Assistant AG for Criminal Div.
September 17, 2014.
Qui Tam cases—stepping up use of FCA as
enforcement tool - committing more resources.
New review process: all new qui tam complaints
shared by Civil Division with Criminal Division
upon receipt. Encourage Qui Tam
relators/counsel to reach out to criminal
authorities when discussing with civil authorities if
Citizen Petitions: What is FDA’s response to
constitutional limits on it regulatory scheme?
Citizen Petitions of Medical Information
Working Group (MIWG)--September 3, 2013.
Challenge to FDA regulations and policies
regarding manufacturers’ communications
about off-label uses in light of constitutional
June 6, 2014 Response from FDA.
Mark C. Levy, Esquire
Two Liberty Place, 50 S. 16th Street, 22nd Floor
Philadelphia, PA 19102
(215) 851-8404 | [email protected]
Embracing 21st Century Information Sharing:
Defining a New Paradigm for FDA’s
Regulation of Healthcare Professionals
December 8, 2014
Biopharmaceutical Company and Healthcare
Professional Information Sharing
Patients expect their physicians to receive accurate, datadriven information about the medicines they prescribe.
• A new paradigm demands regulations that are consistent with
21st Century information sharing.
• Sources of information may include:
 Information in the FDAapproved Prescribing
Information (PI)
 Information on use of medicine
based on real world evidence
(e.g., health records, payer data)
 Peer-reviewed medical
literature (some information
not contained in PI)
 Sub-population analyses (e.g.,
results based on gender)
 Information on costeffectiveness (not in PI)
 Medically-accepted, reimbursed
alternative uses of approved
Sources of Information about Medicines
for Healthcare Professionals
Lectures and
Post-market Safety and
Effectiveness Data
Clinical Practice
Advertising and
Journal Articles
Clinical Trial Data
Social Media
Analyses from
Health Records
Calls for Regulatory Reform
E&C call for comments from patients
“How do you learn about new treatments and cures? How do you
communicate with other patients regarding treatments and cures?”
House Energy and
Commerce Committee White
Paper on 21st Century Cures
“Communication about how certain
treatments are working in certain
patients is happening through a
multitude of media around the globe.
These conversations between and
among doctors, patients, researchers,
and scientists in academia and industry
should be facilitated. This includes the
free flow of data, research, and results
related to what a therapy or combination
of therapies does or does not do well
and in what types of patients. We need
to harness the power of the Internet and
social networks.”
Society for Women’s Health Research
“We believe open and transparent communication of important
scientifically accurate data is important to advancing medical
treatments in the digital age. Access to company data should be
established in a way that provides for appropriate communication to
health care professionals and patients on medication usage that
could improve patients’ health outcomes.”
National Organization of Rare Disorders
“The government severely restricts what drug companies can say
about new research and about off-label uses, thus cutting off
information from the most knowledgeable sources. The Congress
should seek new policies that permit drug companies to share
appropriate information without fear of enforcement action.”
Patient and Provider Groups Speak Out
The Alliance urges FDA to
reconsider some of its
proposed language changes,
which could potentially chill
off-label use of oncology drugs
and the dissemination of
scientific information about
non-approved uses.
- The Ovarian Cancer National Alliance, May 2014
To enhance patient care, physicians
must have unrestricted access to
truthful, non‐misleading
information about the benefits and
risks of all therapies available for
treatment, including medically
accepted alternative uses of
approved prescription drugs,
biologics, and/or devices.
- The Alliance of Specialty Medicine, May 2014
Principles for a New Regulatory Paradigm
• All communications about medicines should be truthful and
• Should apply to companies, government, payers
• Proactive as well as “unsolicited”
• Regulation should balance patient benefit and potential risk
Approved Uses/Approved Medicines
• Permit truthful and non-misleading information beyond the approved labeling
Medically Accepted Alternative Uses of Approved Medicines
• Supported by clinical guides/medical compendia/reimbursed by govt./private payers
• Permit truthful and non-misleading information beyond the approved labeling
• Specifically disclose that use is not FDA-approved
Non-Medically Accepted Alternative Uses of Approved Medicines
• Limited to Exchange between Scientifically-Trained Professionals
Investigational Medicines
• Limited to Exchange between Scientifically Trained Professionals
Principles for a New Regulatory Paradigm
• Disclosures/Disclaimers Preferred Over Restrictions
– Disclose limitations of data instead of always requiring “two adequate and
well controlled studies”
– Communications should disclose regulatory status of medicine/treatment
• Recognize the Need to Provide Incentives for Sponsors
– Disclosure of regulatory status encourages development of supp. approvals
– FDA should explore innovative pathways for supplemental approvals
• Companies Must be Able to Provide Adequate Directions
– For approved and medically accepted alternative uses of approved medicines
– Providing needed information should not constitute failure to provide
adequate directions for use
• “Labeling” Should Comport with Statute
– Non-physical and oral communications are not labeling
Areas for Potential Safe Harbors
• FDA should create clear safe harbors for truthful, non-misleading
communication about
– approved uses
– medically-accepted alternative uses
• Potential areas for sponsor information sharing to enhance
patient care include:
Observational data and “real world evidence” (e.g., registries, EHRs)
Pharmacoeconomic information
Sub-population data and other endpoints (e.g., gender and race)
Retrospective data analyses
Claims supported by less than two adequate, well controlled studies
• FDA guidance should address appropriate methods to qualify
and describe information and data so that trained healthcare
professionals may evaluate and assess

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