Introduction

I have been involved with the life science and healthcare industries for many years. As a pharmacist who still dispenses medications and as a lawyer who works with a variety of pharmaceutical providers, I have become a valuable resource for companies and friends in the life science and healthcare industries.

Recently, my friend Joe and I got involved in a discussion on the promotional pieces that life science companies (particularly medical device companies) put out and how they are seemingly “useless.” Joe pointed out that the advertisements begin with talk of the “miracle” device that supposedly cures this debilitating disease, yet ultimately nullify those claims by the end of the piece. He then asked: “Why even bother making the advertisement?”

Joe’s confusion made me realize that many advertising professionals don’t appreciate either the efforts that a medical device company makes in showing compliance, or the efforts that the FDA makes in ensuring that patients are safe. This concept becomes extremely important when one is discussing software companies, which can be deemed medical devices. For Joe, who doesn’t work in the life science industry, the FDA had failed to communicate the extremely restrictive limits on promotional compliance, as well as the burden placed on these medical device companies.

So, I realized it made an excellent topic for a brief discussion on the system that medical device and pharmaceutical companies must adhere to.

Stakes

During my conversation with Joe, I began by explaining the stakes: Life science companies, including drug and device companies, have paid multi-billion-dollar fines resulting from non-compliant promotion. The FDA, as part of its expectations of quality, requires that companies have a system in place to ensure that their promotions meet FDA expectations. If they don’t, they risk fines and penalties; and in certain cases, jail time for the perpetrators and possibly even their supervisors.

How do I Avoid These Fines, Penalties and Jail Time?

The FDA expects that companies follow an appropriate “Quality System” to avoid these fines, penalties and jail time. The American Society of Quality (ASQ) recommends that companies adhere to the Plan Do Check Act System, which is a standard component of pharmaceutical and medical device companies.

Part of this system involves having a Promotional Review Committee (PRC) or a Medical Legal Review (MLR) Committee to review any external-facing promotional and non-promotional pieces (“Pieces”). These committees are expected to ensure that Pieces adhere to the many requirements from the FDA, which are based on the laws, changes to the laws, regulations, guidances, titled and untitled letters. Because they are often changing, adhering to these requirements is often difficult. An MLR Committee typically has, as expected, three core members:

  1. Medical: These individuals typically work in the Medical Affairs department and often have terminal doctorates such as a Doctorate in Pharmacy, Medicine or a PhD in the life sciences. They are expected to review a proposed Piece to evaluate whether it is compliant with FDA and Federal Trade Commission (FTC) expectations and the approved package insert. Depending on the specific type of claim being made, different levels of proof may be required. Recent court rulings have determined that companies may occasionally be able to go beyond the package insert – provided that such claims are “truthful and non-misleading.” Members of the “medical” team are expected to evaluate such claims.
  2. Legal: These individuals are attorneys with a Juris Doctor degree and typically work in the legal department, although occasionally called from the compliance department. They may be asked to evaluate if the proposed Piece or program might violate a number of laws, including HIPAA, the False Claims Act, Anti-kickback law, preexisting agreements, etc.
  3. Regulatory: These individuals are often well-versed in FDA requirements and review claims in the context of FDA expectations.

What does this MLR department do?

This MLR Committee is the last line of defense for the company and must work to ensure that people within the company or the company itself is not fined or otherwise penalized. One of the requirements is ensuring that there is “fair balance” in the appropriate Pieces. “This means that the content and presentation of a drug’s most important risks must be reasonably similar to the content and presentation of its benefits.” This is where the many “ask your doctor if this product is right for you…” type of ads may arise. If promotional Pieces don’t list the risks, companies and individuals may be targeted by the FDA. Such efforts may affect profits or result in fines and other penalties (including jail time.)

Limitations

According to Advertising Agencies

Advertising agencies often complain that internal MLR departments are opaque and can delay creative projects. These delays can cost a company millions of dollars.

Additionally, MLRs are viewed as the “boogie man”. When companies spend time, money, energy and effort to create a potential pitch for companies, there have been several situations where the proposed idea was not warmly greeted because brand managers have simply asserted that “MLR will not go for it”. Allowing Advertising Agencies to assert that a concept has been MLR Vetted would be useful to overcome these limitations.

According to Medical/Scientific Writing Companies

Medical writing companies have the ability to create write-ups, PowerPoints and other scientific publications. In some cases, they are even tasked with creating Pieces that speak to the off-label uses of a product. In such situations, the companies must be careful that they don’t inappropriately promote the product off-label and expose themselves to significant liability. Often, the only defense the medical writing companies have against inadvertently inappropriate claims is the internal MLR review. However, it is critical to recognize that internal MLRs protect the medical device company or drug company, but not the medical writing company itself. Companies that recognize this are often concerned about the exposure to liability.

According to Internal Medical Affairs Departments

Medical Affairs typically views MLR as critical, but fraught with risk. Members of the Medical Affairs department serve the “medical” function and are expected to provide unbiased advice. This is difficult in the instances in which they are consulted during the development of the concept itself and are therefore “invested” in the idea.

Additionally, since the Pieces created for the brand are usually deemed more time sensitive, they are seen as more important and therefore receive more attention.

According to Brand Managers

Pieces created for the Brand are often required to be timely. Delays in approval of Pieces can cost companies hundreds of millions of dollars in potential sales and may affect sales commissions that may accrue. Accordingly, Brand Managers often see MLR committees as the rate limiting step – they are necessary and helpful, but can, all too often, be overburdened, and slow.

Solution

Using an Outsourced MLR Team

It is important to recognize that while companies have traditionally tried to keep the MLR function in-house, it has been difficult to do so due to costs and limited numbers of qualified personnel. The Kulkarni Law Firm provides this as an outsourced service for both large and small companies. The service allows organizations to remove their fixed overhead and have a trustworthy and reliable company to review potential ideas and concepts to address concerns expressed by internal teams.

Of note, the Firm provide the internal Medical Affairs group with peace of mind. Medical Affairs is often involved not only in the concept review, but may be consulted from time to time throughout campaign development. Medical Affairs hence “buys in” to the idea and may be unable to provide impartial advice on potential claims made. Our Firm provides an unbiased perspective on these potential ideas.

Additionally, members of the internal Medical Affairs group often complain that media created for their own use is, at times, relegated to being of lower importance; its review is often rushed. Our firm can prioritize and effectively review these materials and provide companies with peace of mind.

Conclusion

Outsourcing MLR review to the Firm hence allows Companies and their contractors like advertising agencies and scientific writing companies to focus can provide for a quick and efficient review which allows Companies to bring their promotional and non promotional pieces to market quicker. The Kulkarni Law Firm provides such an outsourced MLR Review service.