Trend Brings Increased Scrutiny to Drug and Medical Device Research Activities

In 2012, the Office of Inspector General (OIG) announced corporate integrity agreements with four pharmaceutical companies: Abbott Laboratories (May), GlaxoSmithKine (June), Boehringer Ingelheim (October) and Amgen (December). Some of the settlement terms and conditions in these agreements highlighted OIG's increasing interest in research and development (R&D) as a compliance focus area.

More specifically, the agreements included compliance requirements concerning clinical research, scientific authorship and publication practices, some of which are summarized below. Each of these obligations was included in the final negotiated corporate integrity agreement (CIA) as a requirement that the company develop written guidance. However, the process of developing written guidance almost always necessitates a change or formalization of company practices as well as means for making sure the guidance is followed. As a result, the company's response to this requirement from the government will go beyond simply stating a legal obligation in documents; it requires implementation of clear business objectives that can be monitored in practice as well.

Note 1: Some of the obligations specific to GSK and Amgen are reported as representations of the company, which presumably means the measures were in place before the CIA settlement was finalized. It remains to be seen whether these voluntary measures will become requirements in future agreements.

Note 2: Each CIA included provisions directed at the sales and promotional functions of the organization as well; however those are not discussed here.

After reviewing the GSK agreement I asked the OIG whether we could expect to see more CIA directives aimed at the research arm of a pharmaceutical or medical device company. Here is their response:

         Research and publication of research results, including those results adverse to a company’s 
         prescription drug, is an area of interest to the Office of Inspector General. It is, however, difficult to 
         predict exactly what provisions future CIAs will have without knowing the specific facts of the 

There were other requirements in the CIAs that affected the sales and payor organizations of the companies as well. One of these was a requirement that each GSK business unit appoint an Integrity Champion. I asked OIG about this concept of an Integrity Champion, and whether this requirement might also be repeated in future CIAs. They responded:

        CIAs are tailored to address the facts and the types of compliance risk areas that arise in each 
        case and to reflect the company’s current compliance program, (such as with the requirement for 
        Integrity Champions). 

Corporate integrity agreements are becoming increasingly common to healthcare institutions and service providers as well. While those organizations may not conduct research for product development, hospitals and clinicians are integral to the development of data used to support product approvals. Therefore, the government’s increasing focus on research activities will also impact these organizations.   Beneath the most basic analysis of this trend appears to be the OIG’s interest in making sure that any data generated in support of promotion, use or sale of products eligible for government reimbursement meets a certain standard of integrity. In this respect, it would not be surprising to see compliance requirements imposed on non-manufacturers that reach back into patient data and institutional quality systems as well.

1) Abbott Laboratories Corporate Integrity Agreement dated May 4, 2012
2) GlaxoSmithKline, LLC Corporate Integrity Agreement dated June 28, 2012
3) Boehringer Ingelheim Pharmaceuticals Corporate Integrity Agreement dated October 22, 2012
4) Amgen, Inc., Corporate Integrity Agreement dated December 12, 2012
5) July 2012 correspondence with the Office of External Affairs, Office of the Inspector General, Washington, DC

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Mini White Paper

Research & Publication Practices

1. All sponsored research must address a legitimate scientific question or need and must be approved by 
    the relevant research governance organization.

2. Establish requirements and procedures for sponsorship or support of post-market research involving 
    consented subjects and government-reimbursed products.   
   (a) Conducted by physicians licensed to practice in the US. 

3. Sponsored research and investigator-sponsored studies of these government-reimbursable products 
    must be approved by the medical or research organizations.
   (a) Sales, marketing or other commercial teams may not participate in study design, conduct or 
   (b) Exception for non-interventional health outcome studies (overseen by medical).
   (c) Human subject research and resulting publications are for the purpose of fostering increased 
         understanding of scientific, clinical or medical issues.
   (d) Researchers must disclose, as a condition of funding, that the company’s support, and any financial 
          interest the researcher may have in the company, are disclosed in the publication of the research.

4. Company to disclose sponsorship of post-marketing clinical trials, post-marketing studies and 
    investigator sponsored studies of government-reimbursable products.

5. Company to disclose financial support for post-marketing study investigators and medical writers.

6. Establish policies for notification of institutional review board or ethics committees about premature 
    discontinuation of sponsored research, including reasons for termination.

7. Establish policies and procedures for reporting of adverse events to FDA.
    (a) Require reporting of adverse events by investigators and other study-related data to the company 
          before final payment is made by the company.
    (b) Assess sponsors of investigator sponsored studies for compliance with safety reporting 
          requirements per contractual agreements.

8. Appropriate conduct of Product Related Functions (which include preparing and disseminating non-
    promotional materials, and hiring healthcare professionals for post-marketing studies or authorship and 
    publication of study results).

9. Procedures for response to requests for information about off-label uses for government-reimbursable 
    drugs by medical information or medical affairs.
    (a) Obtaining the requestor’s signature and written affirmation that the request was unsolicited.

10. An inquiries database to be maintained by medical affairs or medical information staff. 

11. Develop materials, information and procedures for distribution medical information to healthcare 

12. Consulting arrangements with healthcare professionals and institutions for activities such as advisory 

13. Establish procedures for the way in which medical affairs or field-based medicine staff (often part of 
      the research organization) may interact with healthcare professionals and representatives of 
      healthcare institutions at meetings.

14. Required publication of sponsored research and its results.

15. Publication of study results in peer-reviewed, searchable journals, where possible.
      (a) Company must make a “good faith effort” to seek publication.
      (b) Establish written requirements for Investigator Sponsored Studies which require the investigator 
            to use best efforts to publish study results.

16. Listing of clinical trials, including any updates or status changes, for access by the public.

17. Develop a (company) clinical study register for posting results of interventional research studies of 
      government reimbursable products, sponsored observational studies, study analyses and summaries of 
      study protocols; as well as publishing about discontinuation of studies.

18. Establish requirements for use of information resulting from research (e.g. for journal articles or 
      promotional materials).

19. Review of submissions to Compendia or other resource databases that provide information about 
      government reimbursable products.
Related Company CIA

1. Amgen

2. Amgen, GSK
    (a) Amgen

3. Amgen, GSK
    (a) GSK
​    (b) GSK
    (c) GSK
    (d) GSK

4. Abbott, Amgen, BI, GSK

​5. GSK

6. Amgen

​7. Amgen, GSK
    (a) Amgen, GSK
    (b) Amgen

8. Amgen, BI, GSK

9. Abbott, BI, GSK
    (a) GSK

10. Abbott, Amgen, BI, GSK

11. Amgen

12. Abbott, Amgen, BI, GSK

13. Abbott, Amgen, BI, GSK

14. GSK

15. Amgen, GSK
      (a) Amgen
      (b) Amgen

16. Amgen, GSK

17.  Amgen, GSK

18. GSK

19. Abbott, Amgen, BI, GSK

20. Abbott, Amgen, BI, GSK
      (a) Abbott, BI, GSK
      (b) Abbott, BI, GSK
      (c) Abbott, BI, GSK

21. Amgen, BI, GSK

22. Amgen, GSK

23. Amgen, GSK

24. Amgen, BI, GSK
Authorship Related Practices

20. Policies for authorship of journal articles or other publications about government-reimbursed   
      products, generally.
      (a) Including disclosure of any and all relationships between the author and the company’s research 
      (b) Identification of all authors or contributors (including professional writers) associated with a 
            given publication.
      (c) The scope and breadth of research results made available to each author or contributor.

21. Limit the determination of “authors” to persons who have made substantial contributions to the study 
      and who gave final approval of the publication.

22. All authors of journal articles to adhere to International Committee of Medical Journal Editors 
      requirements unless a particular journal requires an alternative procedure.

23. Company employees must also certify the claim of authorship.

24. Disclosure of the compensation relationships with the authors, contributors or professional writers of 
      articles about company-sponsored research.

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