Frequently Asked Questions: Policy on Interaction with Industry

1. 1.       Gifts to Individuals from Industry
   Question:  At my professional society meetings, registrants are given the conference program material in a tote bag with the name of the society and the name of a pharmaceutical company that I assume paid for the tote bags.  May I accept the bag?
   Answer:  The policy does not prohibit you from accepting the bag, even with the company logo.  However, the practice of company support for professional societies in exchange for marketing opportunities (such as printing the company name and logo on conference material) is coming under scrutiny.  You should consider recommending that your society eliminate the practice. [go to section 2(a) of policy]
   
   Question:  Every year, there is a week devoted to recognizing a particular group of allied health professionals in the hospital, and it is coming up soon.  As director of these staff members, I have been asked by outside vendors and others whose services we recommend to patients whether they can provide food and small gifts to our staff members.  Is this ok?
   Answer:  Whether these companies and organizations are vendors doing business with Hopkins or the recipient of referrals by Hopkins staff, they benefit commercially from the work of your staff.  Food and gifts may consciously or unconsciously influence the decisions made by the staff.  As stated in the policy, the offers of food and gifts may not be accepted.

• Food
  Question:  A company that manufactures important devices in my field wants to host a dinner for fellows from five select institutions at our next professional society meeting.  The dinner will be at a well-known, expensive restaurant.  Can my fellows attend?
  Answer:  The company is organizing the dinner to buy goodwill and loyalty from specialists who will soon be in practice.  The dinner is a gift and should not be accepted.  [go to section 2(b) of policy]
  
  Question:  A pharmaceutical company is supporting a visiting professor who will lecture at grand rounds in my department.  I understand the company cannot supply food for this event.  It’s scheduled at 8 am, and I would like to serve breakfast.  What are my options?
  Answer:  Ask your department director if there are unrestricted funds that you can use for this purpose.  Department directors may choose to use pooled funds donated by companies and others to support meals at such events. [go to section 2(b) of policy]
  
  Question:  As a nurse-manager, I supervise several nurses on an inpatient unit.  We routinely use equipment from a particular large medical supply company.  Although I serve on a committee that makes purchasing recommendations, I am one of about fifteen members.  Each year at Christmas, the company sales rep sends a fruit basket to my nursing unit.  Can we accept the basket?
  Answer:  While the fruit is no doubt appreciated, it is a gift from an industry representative and therefore should not be accepted.  As of July 1, 2009 industry sales representatives will have to certify that they agree to abide by the JHM Interaction with Industry policy, which does not permit JHM staff to accept gifts from industry.  If you receive the gift again, you should notify your department administrator who should politely remind the sales representative that the policy does not allow acceptance of gifts.  In the meantime, it’s recommended that you deliver food items to a food bank or soup kitchen. [go to section 2(b) of policy]

Question:  As a nurse manager, I must earn a certain number of continuing education (CE) credits each year.  Many of the CE events sponsored by the American Nurses Credentialing Center (a subsidiary of the American Nurses Association) are sponsored by healthcare companies.  If I attend an ANCC event that is sponsored by a company, can I accept the meals that are part of the program?  

Answer:
ANCC, ACCME (Accreditation Council on Continuing Medical Education) and most continuing education accrediting bodies in the health professions have standards for commercial support of their continuing education events.  Provided the event is accredited by a group that has such standards and that the standards provide for independent development of educational content and transparency of commercial support, Johns Hopkins staff may accept meals that are part of the accredited CE program.

• Unrestricted Gifts
  Question:  I conduct basic science research and clinical research, and I have a clinical practice.  One of the drug manufacturers in my specialty field would like to make a gift to my discretionary account.  I plan to use the funds to do some exploratory studies in the lab and, if the results are promising, use the preliminary data to apply for an NIH grant to continue the basic research.  May I accept the gift?
  Answer:  The policy requires that unrestricted gifts be directed to the institution and deposited in a departmental or divisional account and not in an individual’s discretionary account.  The concern is that, while the recipient may use the gift funds for independent research, the act of making the gift might create a sense, albeit unconscious, of reciprocity.  You should ask the company to direct the gift to your department or division.  The director should set up a mechanism for faculty to request unrestricted support from a pool of money – the funds from this company and others.  The division or department can acknowledge the company’s support, along with unrestricted support from other sources. [go to section 2(c) of policy]
  
  Question:  The hospital recently purchased a new piece of equipment that is used for performing a particular outpatient procedure in our clinic; the procedure is faster and potentially safer using this equipment.  The product is new and has been installed at only a few other practices in the region.  The manufacturer would like to print and mail several thousand post-cards advertising that our clinic uses the new equipment for this procedure.  We would provide the company a list of patients and referring physicians we would like to receive the announcement.  Is this acceptable?
  Answer:  The manufacturer is offering to provide your Hopkins clinic a gift in the form of printing and mailing of advertising material, with the dual purpose of marketing your clinical services and their equipment.  Unlike an unrestricted monetary gift that your department can use at its discretion for education, research or patient care, the purpose of this offer is to promote the vendor’s product – and incidentally clinical services at Hopkins.  Accepting a gift from a vendor may raise questions or the appearance of a quid pro quo.  In addition, Hopkins services should be marketed and promoted in accordance with JHM marketing standards and should not be supported financially or in-kind by vendors.  Finally, providing patient names to a third party without the patients’ permission may violate HIPAA regulations.  So this offer cannot be accepted.

• Pharmaceutical Samples
  Question:  I run an outpatient psychiatry clinic and some of our indigent patients arrive at the clinic in urgent need of medication to control psychotic symptoms.  We have historically relied on free samples provided by pharmaceutical representatives.  Now that we can no longer accept samples, how are we to treat these patients?
  Answer:  JHM physicians and staff should inform patients about affordable options for obtaining medications such as pharmaceutical assistance programs and large retail chains.  In-house resources are also available through JHM social workers. [go to section 2(d) of policy]

• Site Access for Pharmaceutical Industry Representatives
  Question:  A scientist I know at a large pharmaceutical company will be in Baltimore on the day of my department’s next grand rounds.  The topic is closely related to her areas of expertise.  May I invite her?
  Answer:  If she signed in according to JHM site access rules, she may attend the grand rounds.  However, industry representatives may not attend JHM meetings or rounds where patient-specific information is discussed; they may not attend lab meetings or other meetings where proprietary data are discussed; they may not be in patient care areas; and they may not distribute company literature at hospital meetings.  [go to section 2(e) of policy]
  
  Question:  I direct resident training in the clinic where I practice.  The FDA recently approved a new drug for a disease we treat and the drug is based on a novel chemical compound.  The clinical trials have been published, but the residents are not familiar with the chemistry behind this new drug class.  I would like to invite a representative of the company to speak with the residents and possibly to deliver grand rounds.  Is this permissible?
  Answer:  It is appropriate to support education about new drugs.  You may first wish to ask that a JHM Clinical Pharmacy Specialist with expertise speak about the drug.  A company representative may be invited to present information about a new drug, but that should be done by a scientific representative and not sales staff.  The presentation should be conducted in a supervised, structured group setting with the opportunity for questions and critical evaluation.  A faculty member should supervise any involvement of students or trainees.  No promotional material should be distributed and there should be no access to patient care areas.
   
• Site Access for Device Industry Representatives
  Question:  Many of my patients are fitted in our clinic for specialized braces.  The fit of the brace must be inspected by professionals in the clinic, so the company representative comes to the clinic by appointment.  Is this ok?
  Answer:  Fitting the brace in the clinic is a necessary component of on-site care for these patients.  This is permitted, provided the conditions for site access by device representatives are met. [go to section 2(f) of policy]

• Patient Education/Promotional Material
  Question:  I’m the administrator of an outpatient clinic.  Can we accept and distribute material provided by industry that has educational value for patients?
  Answer:  The preferred source of educational content for patients should be JHM-branded material.  Industry-provided material should not be used if it promotes branded products (unless necessary for safe and effective use such as a package insert) or if it includes discount cards, vouchers, samples or similar items.  Industry-provided material may be used if there’s a clear need for the content, the content is not available from a trusted, non-industry source (e.g., CDC), and the content has been reviewed by JHM clinical experts.  Industry representatives offering educational material to JHM clinics must deliver the material to the appropriate administrator so it can undergo the appropriate review process.  Industry representatives may not display or distribute the material themselves.  For additional details, contact the Office of Interaction with Industry.
   
• Industry-sponsored Programs
  Question:  A company has asked me to speak on a topic in my area of expertise during an upcoming professional society meeting.  The company is requiring that they review and approve the content of my presentation in advance and they’ve told me the purpose is to ensure there is no product promotion and that my statements are adequately sourced.  Although the program is administered by the company’s marketing division, I’m told the goal is educational.  May I participate?
  Answer:  The company appears to have good reasons for requiring prior review and approval of your content, but there is no assurance that they won’t require revisions to your material.  And while their review may not result in the addition of material that overtly favors the company’s drug or device, it may shape your content so as to influence opinions about optimal treatments, such as those involving their products.  Under the policy on industry-sponsored programs, you must be able to control the intellectual content of your program.  [go to section 2(h) of policy]
  
  Question:  I have been invited by an academic institution on the west coast to deliver grand rounds.  I believe the program is being supported by industry, although I don’t know which companies are involved.  My hosts have invited me to dinner the evening before the talk at a restaurant where I’ll have a chance to talk with several faculty in my field.  If the dinner also is being underwritten by industry, may I attend?
  Answer:  You were invited by another academic institution, not by industry.  Even if industry is supporting the program, it’s the institution that has invited you and is organizing the academic program and dinner.  As long as there is no industry control over your talk, you may give grand rounds and attend the dinner. [go to section 2(h) of policy]
  
  Question:  For several years, I have been a consultant to a pharmaceutical company.  The company just received FDA marketing approval for a drug in my field of expertise.  They have asked that I train physicians who have agreed to serve on their speakers bureau for this drug.  I know that JHM and SOM policies prohibit me from serving on a promotional speakers bureau.  May I train the speakers?  Does it matter whether I use the company’s slides or my own slides in the training?
  Answer:  The proposed activity directly supports a type of speaking that is not allowed under JHM and SOM policies.  While you would not be directly promoting the company’s new drug, by training speakers you would be enhancing the company’s promotional capacity, and your expertise and Hopkins affiliation would add to the credibility of the activity in the view of the trainees.  This activity would not be allowed, whether or not you use your own slides, because in effect it is a promotional activity on behalf of the company and inconsistent with the policies and principles of Johns Hopkins.
   
• Disclosure
  Question:  I know that when I lecture to medical students, I need to include a disclosure slide in my PowerPoint presentations or a page in the printed material I distribute listing my relationships with companies if the relationships are related to the topic of the lecture.  What is the time period for disclosure?
  Answer:  You should disclose all relevant industry relationships in effect within one year of the lecture.  If the relationship ended earlier than a year prior to the lecture, there is no need to disclose it in this setting.  [go to section 2(h) of policy]
  
  Question:  What should I disclose?
  Answer:  You should disclose all relevant relationships involving personal payments (e.g., consulting, advisory board service, speaking) and fiduciary roles (e.g., board of director service).  While it is not necessary to disclose sponsored research or grant support, you may want to consider doing so.  [go to section 2(h) of policy]

1. Travel
   Question:  We purchased a new assay machine for our pathology lab and it’s essential that a member of the lab attend one of the vendor’s training sessions.  The vendor pays all expenses, including travel, for clients to attend these sessions.  Can we send one of our research assistants?
   Answer:  Yes, provided that the training cannot be provided on-site at JHM and the expenses are reasonable.  The company should not provide gifts or entertainment in the course of the training.  It is strongly recommended that the training sessions and expenses be incorporated into any purchase contracts with the vendor.  [go to section 2(j) of policy]