Drug And Device Marketing And Compliance Outline

1. Relevant Statutory Authority

   1. 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.

   2. Food and Drug Administration Modernization Act of 1997 (FDAMA)

      1. Amended the FDCA by:

         1. Streamlining the drug approval process and eliminating many outdated components of the drug license application

         2. Increasing patient access to experimental drugs and medical devices

         3. 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.

   3. 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

   4. 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

         1. Detailed guidance yet to be issued

         2. Information posted cannot be promotional in nature or content

         3. Discourages input of non-Medical personnel in drafting, reviewing, and posting clinical trial data

   5. 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.

      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.

2. Introduction

   1. FDA Oversight Authority

      1. Regulatory requirements for drug approval establish a barrier to market entry for compounds lacking “substantial evidence” of safety and efficacy

         1. 2 “adequate and well-controlled” studies

         2. Labeling reviewed and approved that reflects safety and efficacy information for approved indications (i.e., supported by data submitted and reviewed)

         3. Regulatory action (Warning/NOV Letters reflecting expansion of the approved indication, risk minimization)

      2. FDAAA

         1. FDA prohibits introduction of a “misbranded drug” into interstate commerce (21 U.S.C. § 331(a))

         2. A drug is “misbranded” if its labeling is “false or misleading” (21 U.S.C. § 352(a)) or if labeling does not contain “adequate directions for use” (21 U.S.C. § 352(f)(1))

         3. 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, January 2009)

   2. OIG Guidance

      1. “OIG Compliance Program Guidance for Pharmaceutical Manufacturers” (2003)

         1. Non-binding, voluntary OIG guidance on elements for an effective compliance programme for pharmaceutical manufacturers

         2. Reflected intention of federal government to examine industry practice

   3. 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 Manufacturers

      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

   4. FDAAA

      1. Requires registration and reporting of clinical trial results of drugs and devices subject to FDA regulation

         1. Detailed guidance yet to be issued

         2. Information posted cannot be promotional in nature or content

      2. Discourages input of non-Medical personnel in drafting, reviewing, and posting clinical trial data

   5. CIAs

      1. The CIA is the primary enforcement tool used by the OIG to promote health care compliance

         1. Entered contemporaneously with government settlement of FCA/related health care fraud statute violations

         2. Allows settling party who is alleged to have engaged in fraudulent conduct to continue to participate in federal health care programmes

         3. Average CIA time period is 5 years

      2. Theory and practice

         1. 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

         2. Relevant...

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