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Drug and Medical Device Marketing and Compliance Outline
I. Relevant Statutory Authority
A. Food, Drug and Cosmetic Act of 1938 (FDCA)
1. Established the legal framework within which the FDA operates.
2. Originally authorized the FDA to oversee the safety of food, drugs, and cosmetics.
3. Has been amended several times to address drug efficacy, development and approval of orphan drugs, medical devices, and dietary supplements.
4. Misdemeanor provision contains a strict liability standard that has been relied upon to find corporate officers strictly liable for company actions, absent direct knowledge on the officer's part.
B. Food and Drug Administration Modernization Act of 1997 (FDAMA)
1. Amended the FDCA by:
a. Streamlining the drug approval process and eliminating many outdated components of the drug license application b. Increasing patient access to experimental drugs and medical devices c. Requiring a manufacturer to notify patients when it intends to discontinue a drug that is life-sustaining or treats a serious and/or debilitating disease.
C. Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b
1. "It is a felony for a person or entity to knowingly or willfully solicit or receive any remuneration in return for referring an individual for the furnishing or arranging for the furnishing of any item for which payment may be made under a federal health care program, or in return for purchasing, leasing or arranging for or recommending the purchasing or leasing of any item for which payment may be made under federal health care programs…."
2. Penalties may include fines, imprisonment, civil monetary penalties, and exclusion from the Medicare, Medicaid, and/or other federal or state health care programmes
D. Food and Drug Administration Amendments Act of 2007 (FDAAA)
1. Updated the FDCA to reauthorize PDUFA, which provides resources to FDA to help it review new drugs more effectively, and the Medical Device User Fee and
Modernization Act (MDUFMA), which allows FDA to improve the medical device approval process.
2. Requires registration and reporting of clinical trial results of drugs and devices subject to FDA regulation a. Detailed guidance yet to be issued b. Information posted cannot be promotional in nature or content c. Discourages input of non-Medical personnel in drafting, reviewing, and posting clinical trial data
E. False Claims Act (FCA), 31 U.S.C. § 3729
1. Imposes liability on both individuals and entities who defraud government programmes by submitting or causing another to submit a bill that contains false information for payment under a government programme.
2. Claims typically involve health care, military, or other government spending programmes.
3. Has become the government's most important weapon against fraud because it has an intent requirement that is easier for the government to prove than criminal alternatives and because of the provision that allows for treble damages. As a result, many FCA cases are settled.
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4. Permits private individuals, called qui tam relators or whistleblowers, to bring an action under FCA and, if ultimately successful, to share in the recovery.
5. Several states have their own false claims acts. Federal law financially incentivizes states to enact state false claims acts that meet certain requirements.
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A. FDA Oversight Authority
1. Regulatory requirements for drug approval establish a barrier to market entry for compounds lacking "substantial evidence" of safety and efficacy
FDA Enforcement Actions a. 2 "adequate and well-controlled" studies
- Common Ground:
b. Labeling reviewed and approved that reflects safety and efficacy information
- Claims/representations for approved indications (i.e., supported by data submitted and reviewed)
being made c. Regulatory action (Warning/NOV Letters reflecting expansion of the
-Inadequate presentation of approved indication, risk minimization)
-Minimization of risk a. FDA prohibits introduction of a "misbranded drug" into interstate commerce information
(21 U.S.C. § 331(a))
-Omission of risk b. A drug is "misbranded" if its labeling is "false or misleading" (21 U.S.C. §
information 352(a)) or if labeling does not contain "adequate directions for use" (21
U.S.C. § 352(f)(1))
of risk information c. FDCA prohibits the introduction of an "unapproved" new drug into interstate commerce (21 U.S.C. §§ 331(d) & 355(a))
3. Good Reprints Practices for the Distribution of Medical Journal Articles and
Medical or Scientific Reference Publications on Unapproved New Uses of
Approved Drugs and Approved or Cleared Medical Devices" (73 Fed. Reg. 9,342,
B. OIG Guidance
1. "OIG Compliance Program Guidance for Pharmaceutical Manufacturers" (2003)
a. Non-binding, voluntary OIG guidance on elements for an effective compliance programme for pharmaceutical manufacturers b. Reflected intention of federal government to examine industry practice
C. PhRMA Code
1. Code created in 2002 as a voluntary marketing code by PhRMA, revised in 2009
2. Code was designated a minimum standard for industry relationships with HCPs under the 2003 OIG Compliance Program Guidance for Pharmaceutical
3. Compliance with the Code is now mandatory under the laws of two states (and is the basis for MA and DC codes)
4. Tracks many but not all recent OIG concerns and CIA requirements
1. Requires registration and reporting of clinical trial results of drugs and devices subject to FDA regulation a. Detailed guidance yet to be issued b. Information posted cannot be promotional in nature or content
2. Discourages input of non-Medical personnel in drafting, reviewing, and posting clinical trial data
1. The CIA is the primary enforcement tool used by the OIG to promote health care compliance a. Entered contemporaneously with government settlement of FCA/related health care fraud statute violations
3 Drug and Medical Device Marketing and Compliance Outline b. Allows settling party who is alleged to have engaged in fraudulent conduct to continue to participate in federal health care programmes c. Average CIA time period is 5 years
2. Theory and practice a. CIAs incorporate the 7 elements of an effective compliance program (See
"OIG Compliance Program Guidance for Pharmaceutical Manufacturers")
and include specific terms depending on the alleged health care misconduct b. Relevant factors considered include:
i. Severity and extent of underlying conduct ii.
Nature and resources of settling entity iii.
Existing compliance capabilities iv.
Evidence of self-disclosure
3. Common elements of CIAs a. Preamble: establishing statutory basis and the intention to "promote compliance" with health care program requirements b. Term and scope: length of CIA and details of scope and coverage tailored to settlement c. Corporate integrity obligations: identifying content and individuals charged with ensuring compliance obligations are met and related program details including training, monitoring and auditing functions d. Independent monitor: details of Independent Review Organization e. Disclosure program: information on internal disclosure and communications program including non-retaliation policy f. Ineligible person: defines type of persons excluded from dealing with manufacturer and information sources g. Reporting: may include a range of reporting obligations including reporting overpayments and other reportable events as well as specific reporting requirements such as monitoring and reporting on FDA regulations and sales/
marketing practices h. New business units or locations: serves to obligate settling entity to report new business units or locations furnishing products provided or covered by a federal health care programme i. Implementation and annual reports: types of reports described j. OIG inspection, audit, and review rights k. Document and record retention: establishes 1 year retention period at end of term in addition to any other statutory, regulatory or internal requirements l. Disclosures: generally allows public disclosure of all submitted reports under 45 CFR Part 5 (trade secret, confidential and proprietary information)
m. Breach and default n. Effective and binding agreement o. Signatory page p. Appendices (if any)
4. CIA themes relating to the pharmaceutical manufacturer a. Off-label and related FDA promotional requirements b. Disclosure i.
Financial payments to HCPs ii.
Clinical trial information c. Board of Directors responsibilities (included in Lilly (2009), Pfizer (2009),
and Ortho-McNeil (2010) CIAs)
i. Responsible for review and oversight of federal health care and FDA
requirements and CIA obligations
4 Drug and Medical Device Marketing and Compliance Outline ii.
Quarterly meetings to review compliance programme implementation iii.
Retain an independent compliance expert to create a review process,
oversee the review, and prepare a written report iv.
Adopt a resolution summarizing its review and oversight function d. Certification process (included in Lilly (2009), Pfizer (2009), and AstraZeneca (2010) CIAs)
i. Identifies senior personnel expected to monitor and oversee activities within areas of responsibility ii.
Establishes annual certification process regarding knowledge and review of compliance-related activities in areas of authority iii.
Personnel may include: President (US Business), VP of Commercial
Operations (such as Sales, Marketing, Brand Team execs), Sales
Directors, Senior Brand Team Supervisors, VP of Medical Affairs
(internal/field-based), Head of Regulatory Affairs for Promotion,
5. Impose stringent requirements and processes, many of which are regulatory in nature a. Strict and inclusive HCP payment disclosure b. Grant and clinical trial payments and results posting c. Contract database regarding consultants and authors d. Expanding posting of clinical trial information e. Risk Assessment and Mitigation Planning (RAMP) - assess and monitor compliance and regulatory risks for individual products and develop customized risk mitigation plans as necessary f. Include FDA Warning Letters as "reportable events"
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III. Clinical Trials
A. Roles for Medical Affairs in Supervising Clinical Trials and Paying Clinical Investigators
1. Supervising clinical trials a. Informed Consent/Investigator Brochure i.
Review of medical and scientific information provided to both research subjects and investigators for full disclosure of the known benefits and risks of the compound ii.
Provide any revisions to the Informed Consent forms and the
Investigator Brochure to reflect newly discovered safety information b. Assure full disclosure to subjects and reporting to regulatory agencies of payments being made to investigators and/or the institution c. Ongoing clinical safety monitoring and prompt reporting of newly discovered safety information obtained, including advising any Data Safety
Monitoring Board (DSMB) and timely reporting to all appropriate regulatory and health authorities
2. Paying clinical investigators a. Pursuant to a written contract, reasonable (FMV), and only based on amount and complexity of work performed i.
Retention, selection, and development of written agreements must be conducted based on:
1) Investigators' qualifications, training, research, and/or clinical expertise and research resources 2) The ability to conduct clinical trials in accordance with good clinical practice and applicable legal requirements ii.
Medical Affairs, acting wholly and independent from the commercial functions (Sales and Marketing), must ascertain that selection is not based on an investigator's prior prescribing history or prescribing conduct by others (the "KOL" effect)
b. Never related to clinical trial outcome c. Establish process to comply with provisions of Physician Payment Sunshine
Act d. Include all payments to investigators in company's self-imposed limit on yearly compensation to HCPs (per PhRMA Code)
3. Reporting data a. Reporting as required to institutions, medical journals (utilizing the newly issued ICMJE conflicts of interest form), federal and state regulatory bodies
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IV. Direct-to-Consumer (DTC) Advertising
1. DTC TV advertising a. Broadcast or cable TV air time that is bought by a company to advertise one or more of its products.
2. DTC print advertising a. Newspaper or magazine space bought by a company and targeting patients or consumers, or a direct mail communication paid for and disseminated by a company to patients or consumers, for the purpose of advertising one or more of its products.
B. Pre-Dissemination Review (See "FDA Draft Guidance for Industry on Direct-to-Consumer
Television Advertisements" (2012))
1. TV drug advertisements (21 U.S.C. § 353b): FDAAA added § 503B to the
FDCA which gives FDA authority to require the submission of any TV drug advertisement not later than 45 days before its dissemination. FDA may make
Note: FDA estimates recommendations concerning:
that it will receive 80 a. Changes that are necessary to protect the consumer good and well-being, or ads/year for prethat are consistent with prescribing information for the product under review;
dissemination review b. Inclusion of statements to address the efficacy of the drug as it relates to from 30 sponsors for specific population groups, including elderly populations, children, and racial
CDER and 2 ads/year and ethnic minorities, if appropriate and if such information exists. (See 21 from 2 sponsors for
U.S.C. § 353b(b)(1) & (b)(2))
c. Inclusion of specific disclosures about a serious risk listed in the labeling of the drug. (See 21 U.S.C. § 353b(e)(1))
2. 45 day review clock: pursuant to § 503B, the FDA must notify a "sponsor" if the
Agency is unable to provide comments within a 45 day timeframe. When the sponsor is notified of the delay, the sponsor must decide whether it will disseminate the TV ad without waiting for FDA comments or whether it will wait for the Agency's comments before disseminating the ad.
3. Resubmissions: sponsors subject to the pre-dissemination review may revise their
TV ads after receiving comments from the Agency but before disseminating the ads, and may request additional comments under the voluntary submission process delineated in 21 CFR § 202.1(j)(4).
C. "PhRMA Guiding Principles: Direct to Consumer Advertisements about Prescription
1. DTC advertising serves the public health by a. Increasing awareness about diseases b. Educating patients about treatment options c. Motivating patients to contact their physicians and engage in a dialogue about health concerns d. Increasing the likelihood that patients will receive appropriate care for conditions that are frequently under-diagnosed and under-treated, and e. Encouraging compliance with prescription drug treatment regimes.
2. Companies should direct their efforts to "foster responsible communication between patients and health care professionals"
3. Companies should give a balanced presentation of benefits and risks associated with the advertised product
4. Provides guidelines for submitting DTC advertisements to FDA for feedback/review.
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