Life Science Compliance Update

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June 04, 2014

Compliance Challenges within Medical Affairs

Last week's World Congress Second Annual Summit on The Evolving Role of Medical Affairs and Thought Leader Engagement in an Era of Transparency highlighted compliance challenges facing medical affairs departments.

Continued regulatory pressure has shifted many "commercial" responsibilities to medical affairs—personnel with medical and clinical experience who bridge the gap from the R&D and commercial sectors. Medical affairs professionals understand the complex research behind their pharmaceuticals, and play a critical role in scientific exchange between companies and healthcare professionals. Recently, their role has expanded to include health economics and outcomes research (HEOR) and pharmacovigilance. Due to the importance of delivering credible medical information and the increased scrutiny on medical affairs, companies must continually update their policies and ensure cross-training between medical and commercial departments.

This article provides the current landscape for medical affairs, recent enforcement actions implicating medical affairs, and best practices going forward.

Medical Affairs Landscape

Medical affairs departments play an increasingly vital role for pharmaceutical companies. As the government has heightened its scrutiny of drug promotion, companies have backed off the traditional sales rep model. Medical affairs emerged in their wake. They possess scientific and clinical experience and provide an important firewall between R&D and the commercial aspect of marketing drugs. Medical affairs personnel have a variety of duties, but can manage key thought-leader relationships, present educational information, answer off-label questions from healthcare providers, and publish trial data.

While there are currently no statutory requirements to have medical affairs functions, the FDA and OIG encourage them to facilitate effective and legally compliant interactions between life science companies and healthcare professionals. Since 2004, several corporate integrity agreements (CIAs) have stressed that the medical affairs function is an important compliance tool and required control around medical information activities.

Enforcement Action Surrounding Medical Affairs Department

Cliff Saffron, Principal, Life Sciences Advisory Practice at KPMG, noted two potentially conflicting trends that continue to change the role of medical affairs. First has been the expansion of the medical affairs role in compliance programs. Medical affairs personnel are not evaluated or compensated for sales goals. Furthermore, their professional background and training place high value on medical and scientific principles of accuracy, fair balance, and transparency.

Second, as the law, regulatory guidance, industry codes, and provider restrictions limited interactions of sales reps with healthcare professions, companies have increasingly looked to medical affairs to fill this gap. The KPMG presentation noted two examples of this: (1) a major expansion in the number and role of field based medical science liaisons (MSLs), and (2) the expanded use of medical affairs personnel in key-opinion leader development and management.

However, there exists a tension between the two trends. Customer-facing and proactive informational efforts can look commercial in nature. Furthermore, as medical affairs teams align more with the commercial sectors, this could potentially compromise the benefit of medical affairs' independent perspective and judgment.

We have followed recent enforcement action and corresponding CIAs for several large companies. KPMG honed in on medical affairs' role in the most recent settlements.

Pfizer (2009): $2.3 billion

  • Sponsored articles on off-label uses, but didn't disclose company's role
  • Developed draft publications and then recruited authors and sometimes listed them as "TBD"

Allergan (2010): $600 million

  • Failure to separate sales and medical affairs activities

Forest Labs (2010): $313 million

  • Failed to disclose negative study results while touting positive results
  • Paid medical writers to publish article discussion positive, but not negative, studies

UCB (2011): $35 million

  • Focused specifically on MSL activities involving off-label promotion
  • Ghost writing

Elan (2011): $203 million

  • CME programs involving off-label promotional information
  • Off-label activities by sales representatives

Abbott (2012): $1.5 billion

  • Use of dedicated sales force to promote in off-label patient settings
  • Use of misleading/unbalanced educational materials

GSK (2012): $3.0 billion

  • Dissemination of false and misleading information regarding Paxil
  • Improper publication activities in light of negative studies

With the changing regulatory environment, it can often be difficult to judge what will be problematic several years down the road when the government begins to analyze past conduct. CIAs have proven to be a useful tool for predicting where the government is heading with enforcement.

In light of the lack of clear guidance, medical affair departments face challenging compliance issues. Juan Nadal, MD of Bayer Healthcare stressed the importance of collaboration between medical affairs and the compliance departments. At Bayer, they have even positioned a compliance officer within medical affairs.

Off-Label Questions: The Importance of Standard Operating Procedures (SOPs)

MSL responses to off-label questions are a hot topic. If an off-label discussion is initiated by a physician (an "unsolicited request"), medical affairs can discuss off-label data within the frames of the request. However, the FDA considers requests for off-label information that are "prompted in any way" by a manufacturer or its representatives to be solicited requests. FDA may consider this evidence that a company intended the drug be used outside of what was specifically approved or cleared by FDA.

Due to this fine line, MSL teams need clear cut policies on how to handle off-label inquiries, including specific SOPs. SOPs can help avoid the risk of unlawful interactions between commercial and medical colleagues. Nadal noted that Bayer went from 20 SOPs to "upwards of 60 or 70 SOPs" in order to completely mechanize the process and get everything "down to a science."

Companies need clear policies on how to respond and document off-label questions from healthcare professionals. Many have embraced using a professional inquiry request (PIR) that is signed by the physician to verify they have made the inquiry and record exactly what the doctor asked. The presenters also strongly recommend companies take a close look at free text documentation of MSL interactions, if the company employs the free text option. Drop down menu options limit the risk exposure.

Notwithstanding a robust compliance program complete with dozens of SOPs, Richard Liner, MPH, JD of Bayer Healthcare noted that there is always a possibility of rogue employees. In this case, "what the government will expect minimally, is that you have the SOPs and policies in place that you trained employees on. As difficult and onerous as it may be…it is a necessary evil," Liner states. Nadal agreed, and noted that without SOPs, "it is very difficult to function in case of an audit." Audience members also stated that it was vital for these compliance procedures to be in plain English and easy to understand and work under. Companies should leverage technology to make compliance as stepwise as "Turbo Tax," as one person called it.

Saffron noted that his experience as a KPMG consultant for Bayer was unique and "refreshing" because it was the medical affairs department—not compliance or legal—who requested clear cut policies and guidelines for medical communications. Other audience members noted that their companies have embraced a proactive approach to writing clear-cut policies. "People in the field need soundbytes," one person noted—with a strong emphasis on what they can and cannot say. IPad apps can help. One app provides spend limits for meals; here technology molds abstract compliance issues into real world scenarios. Other tools include 30-60 second videos that simplify compliance issues. These offer nice alternatives to "reading a black and white SOP."

Saffron also clarified that each company is different and no solution is a one size fits all. A small biotech company, for example, would likely not implement 60 SOPs, but could adopt clear policies that fit the company's culture.

It's important to note that SOPs are tough to write for "gray-area" issues. For example, the presenters discussed "proactive deployment of MSLs to talk to the customers." Certainly, companies shouldn't send MSLs to doctors' offices with the sole purpose to talk off-label. What happens, though, if MSLs go out proactively to discuss approved uses, and then they receive an off-label request? Is this unsolicited? Some might consider the very act of sending MSLs to the doctor's office a "solicitation" because the doctor knows the MSLs are allowed to respond.

Off-Label Issues Involving Health Economics and Outcomes Research

The presentation ended with an interesting discussion on the compliance challenges when managed markets personnel interact with HEOR and MSL field personnel.

Trying to get a product on a managed care organization's formulary is an increasing challenge. HEOR can provide data to help healthcare payers determine if treatments work in the populations they serve, and how much of the drug or treatment cost should be reimbursed by the healthcare system. Companies often must show decision-makers that the drug's price is worth the expense because the product will cost-effective in the long run--perhaps by leading to less hospital admissions. 

Compliance issues can obviously emerge in interactions between commercial payers and HEOR personnel. Companies have address a number of important questions:

  • What studies will HEOR personnel use to convince payers that their company's product should be a priority?
  • What is the company's role in funding these studies?
  • Are the studies complete?
  • Is the company providing fair balance in terms of safety and efficacy?

The presenters used an example of a new diabetes drug. The health economics professional may properly state to payers that "if patients take this drug, hospitals will see fewer admissions for diabetes related conditions." However, HEOR personnel could attenuate that further, and run into trouble. For example: "if you take our drug, you will also be less likely to get diabetes, and you will therefore be less likely to go blind," and then talk about the expenses of blindness or amputations. The company's drug was not approved to treat blindness or prevent amputations.

HEOR activities cannot proactively imply something off-label. However, HEORs generate studies proactively and meet with managed markets proactively. HEORs are not describing products in the traditional sense, but they cannot imply the safety and efficacy of a product beyond what it was approved for. The gray area occurs when HEORs are describing, for example, an on-label budget impact model and they get a question about the drug that may implicate off-label indications.


Clear policies, including well-drafted SOPs and thorough documentation of communications, are essential for companies to navigate the off-label issues that medical affairs personnel deal with on a daily basis. However, the gray areas—off-label requests during med affairs' proactive visits to doctors' offices, and HEOR discussions with managed markets—are both the most contentious issues and the toughest to fully plan for.

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