A flood of new state laws now strictly regulates pharmaceutical and medical device companies' interactions with healthcare professionals, and more are on the way. Unlike the Pharmaceutical Research and Manufacturers of America and AdvaMed codes on interactions with healthcare professionals, which are voluntary, these state laws include fines and penalties for noncompliance. And now Congress is considering the Physician Payments Sunshine Act of 2009, which would also require that aggregate spend for everything from educational funding and honoraria to meals and travel be registered in a national and publicly accessible online database.

Medical Meetings asked four regulatory and compliance experts their views on this increasing regulatory scrutiny of the medical meetings industry, as well as their advice on how to deal with what lies ahead. William M. Mandell is leader of the health law practice at Pierce & Mandell P.C. in Boston. Marjorie E. Powell is senior assistant general counsel for PhRMA, Washington, D.C. Michael Manthei is a partner at Holland & Knight LLP in Boston. And Retta M. Riordan is president of Riordan Consulting LLC, in Westfield, N.J.

MM: What trends do you predict in the near future regarding state laws regulating pharmaceutical and medical device marketing practices? For instance, do you see the Massachusetts law setting a new standard?

Riordan: The major trend that I have seen is a requirement for transparency. If I had to choose three topics that everyone needs to be cognizant of, they would be transparency, transparency, transparency. It is now the key to legislative action and enforcement, and everyone is trying to figure out how to be as transparent as possible.

The second trend is for requirements to ensure that the science is kept pure, that CME programs are kept independent, and that the physician's independent judgment is not swayed at any cost.

Another trend is for the states to take voluntary guidances and enact them into law. For example, California enacted into law the [Office of Inspector General of the Department of Health and Human Services Final Compliance Program Guidance for Pharmaceutical Manufacturers] and the PhRMA code. Neither was drafted with the intent that it become law. If you read the OIG guidance carefully, you realize that the document is aspirational in nature. The word “should” appears in almost every provision; while only once or twice does the word “must” appear. And the PhRMA code was intended as voluntary guidance for member companies, so that even within its own membership, the code was voluntary and not every member had adopted it.

Mandell: I think the general direction we're headed in is toward increased state-level regulation of interactions between pharmaceutical and medical device companies and healthcare professionals. The Massachusetts law to date is the most comprehensive law on the books, but many other states are considering their own versions of a state regulatory scheme to regulate industry's relationship with medicine and industry marketing.

The paradigm change that's happening so rapidly and that we're all trying to catch up with is that the pressure to change marketing practices is now resulting not only in the industry trying to police itself through voluntary efforts, but also in the states passing laws to legally mandate reforms or to prohibit certain marketing practices, including gifts and other interactions.

The essence of the Massachusetts system in effect now and the potential of the federal system under the Sunshine Act, if it's enacted, is to use transparency as a check-and-balance. The idea is that if more information and data are known by the public, the media, public health enforcers, and advocates, then conflicts can be better understood, managed, and addressed. I think other states that are working on legislation are also thinking of it in terms of creating transparency.

MM: Do you expect more state and federal government scrutiny of medical meetings?

Riordan: I think that we are going to see greater scrutiny of meetings. Until a few years ago, CME programs were deemed to be sacrosanct; they were the gold standard. But in recent years — and I think this may have really started when Sen. Grassley began investigating medical education grants — these types of programs have been undergoing intense scrutiny. Government — both state and federal — has been sending the message that several things have to happen. CME programs have to be independent. They can't be tainted by bias in areas such as selection of topics and selection of speakers. They have to be free from undue external influences. Transparency has to be in evidence. The programs have to be fair and balanced.

Mandell: The essence of the reform movement is to shed light on interactions and to prevent what I call “stealth marketing.” That's where these laws are drawing the line.

No one is suggesting that the ads or the exhibit hall be stopped. You may not be able to give out gifts, but you certainly can be there to give information and explain your product. Everyone knows that what happens in the exhibit hall is a commercial presentation by a company. And everyone knows that when you open a journal, an ad is an ad. The essence of the regulation is to have what is truly marketing be labeled and identified as marketing, and to preserve the independence of what purports to be independent, educational, clinical, or research information.

MM: What effect do you think the Obama administration and the healthcare reform movement are going to have on regulations involving pharmaceutical and device marketing, CME, and medical meetings?

Powell: I would anticipate that as healthcare reform moves forward, there is going to be increasing concern with how everybody in the healthcare system keeps up with all developments in treatments. There has, for example, been a lot of discussion of comparative effectiveness research — not just for drugs, but also for all kinds of treatments. For comparative effectiveness research to be beneficial, everybody in the healthcare system has to learn the results of the research.

There will be some focus on pharmaceutical company and medical device company support for CME, but I don't think it's going to be solely focused on funding.There are going to be efforts to make sure that, for example, the educational program is geared toward adult learners and the various ways that they learn, as well as being efficient in terms of time and not just expense.

MM: Do you expect the Physician Payments Sunshine Act to pass this year? If so, what effect will it have on current and future state legislation? The Act says it would preempt state laws, unless they have additional requirements.

Riordan: I think in any other year it probably would have passed, but Congress has its hands full this year with the economy, the wars in Iraq and Afghanistan, healthcare reform, and other pressing matters.

If the Sunshine Act does pass, it will probably not be a panacea. As it stands right now, the preemption provision would be ineffective because basically what it would do is set a floor for state laws, and the states would still be able to enact any laws that had not already been covered in the federal law. Without effective preemption, I think we could end up with not one overarching law, but 52 separate ones — the 50 states', plus the District of Columbia's, plus federal law. That would present challenges for everyone in terms of monitoring the developments, and tracking and reporting spending.

If all vested parties could sit down with Congressional staff and work out language that provides for an effective preemption, it would be far better than the preemption as it stands right now.

Manthei: Assuming the Sunshine Act passes in its current form, it won't achieve what one would expect federal legislation to achieve, which is a uniform standard applicable to all manufacturers throughout the country. Instead, manufacturers would have to monitor all state and federal laws and have individual compliance programs and internal controls available for individual states. This would increase the cost of compliance and ultimately increase the cost of drugs and devices.