Pharma: OIG Compliance Guide Made An Impact
May 8th, 2008 12:00 pm
Five years after the HHS Office of Inspector General issued its compliance guidance for pharma, 92 percent of drugmakers surveyed say the guidelines “significantly impacted” the structure of their medical affairs teams - for instance, have since shifted medical science liasons and thought-leader development teams away from commercial development.
Meanwhile, 8 percent indicate the guidelines had caused a complete overhaul, according to Cutting Edge Information. And none of the 14 drugmakers that responded - a group that included Bayer, Glaxo and Novartis - believes the guidelines failed to have a serious impact.
SP 2
The response of Big pharma has been all smoke and mirrors.. While the direct line-reporting relationship of the MSLs and the KOL groups may have been shifted, who they really work for has not. Their activities are functionally controlled by commercial teams and they are not allowed to be objective. They need to agree with the commercial groups on everything or those teams jump up and down, demand blind loyalty, and go directly to the top complaining about how they’re not getting their way. Anyway, in the end, the MSLs and KOL groups are still part of the business side and eventually are responsible to the commercial leaders. Try operating under that scenario when you have a conscience and want to do the right thing.
Elio Evangelista
Of course MSL and KOL groups are indirectly serving their companies’ business needs. If they weren’t, then those departments would likely cease to exist. Every function in a pharmaceutical company, including R&D, exists to serve the business need. You can say the same thing about every function in any company. At some point, these groups have to provide some value to the company, even indirectly. But that doesn’t necessarily mean that because commercial operations guide pharma companies’ needs that KOL groups and MSL teams aren’t helping to improve healthcare.
Realistic
Get real! Pharma should be held to a higher standard. Their products affect people’s lives and shouldn’t be hyped without the appropriate safeguards. In 2008, there are not adequate safeguards just as there weren’t 5-10 years ago. When commercial puppets medical, bad things happen. Think Vioxx, Avandia, Zyprexa, Neurontin, Oxycontin and all the rest. If Medical Affairs was allowed to do its’ job without fearing for their own existence, it wouldn’t be this way. If anyone in medical brings up any issue or concern, they end up being ostracized and terminated because they’re not a team player! The honest suffer while the cheats make more and more money!
C. Phrma Researcher
The OIG Guidance has had some impact but not nearly the kind of impact suggested in the story. What all large pharma companies have now are compliance policies and training. And many of them have CIA’s. But look around and ask yourself what has really changed. I have worked in the phrma environment for 20 years and I don’t see any real LASTING change from these things. The companies (including my own) just find new ways to do the same things within policies that are broadly phrased. For example, it today’s environment you need a legitimate “reason” to hire consultants. So you create a reason — we NEED insight on this or we NEED expert guidance on that. And you have to pay them at fair market value so marketing folks just pad the hours. It’s a game. Only now the companies play the game in the terms outlined in policies. It’s sad.
And yes, the OIG Guidance moved some companies to create some additional separation between medical and marketing. But marketing controls the money so the separation is only on paper. There is no genuine separation and pretty much everyone knows it except the OIG which seems pretty darn happy to get it’s settlement money, enter a CIA and move on to other targets and the next big pay day. And yes in the end everyone has to show how they add value to the company, including medical. But that is not the answer to every question.
We operate in a regulated environment where the messages that a company makes about its products must conform to product labeling. However, there are some limited exceptions where the FDA has allowed companies to support scientific discussion. One area is CME. The FDA has allowed phrma companies to financially support CME as long as the CME is genuinely independent. And the FDA applies a multi-factor approach to the determination of independence. One factor is whether the CME was supported by medical or by marketing. So I guess the second poster above would simply say that the FDA’s approach is foolish since marketing and medical are essentially supporting the same cause at the end of the day. But the FDA approach is routed in the notion that phrma companies should be able to support the development and discussion of science even if that might involve off-label uses of approved products as long there is a real medical need and as long as such discussions were not supported to advance sales goals. You can debate it but that is the view of the agency and if it were followed fairly, I personally think it makes sense.
The FDA also allows companies to respond to off-label questions. Most companies (or I should say many companies) limit this to the MSL function mostly to limit risk. The idea is that companies should be able to respond to legitimate questions even if the answer may involve some off-label use of the product. But again, the FDA does not want such processes to support sales goals.
So it is easy to say we all support the business in the end. But it is important for people to understand the rationale of having an independent medical function. It was so that there could be some group within the company that could take full advantage of these situations where FDA has been willing to allow companies to participate appropriately in scientific dialogue.
What I have seen in person is that companies tried after the OIG guidance to bring about some additional separation but that is slowly eroding. As money gets tighter, marketing leaders again want more and more control of every dollar spent. The policies still reflect separation but the practice demonstrates otherwise.
And as this happens I see more and more concerning trends. I have even seen situations where business leaders wanted MSL’s to have goals on how many off-label questions they answered in a month. I have seen business leaders want increasing input and control over CME grants and I have colleagues who have business leaders who want to see the value in these programs from a sales perspective. And yet we hope that these still pass the test of “independence”.
The pengelam is swinging back. The age of the OIG Guidance while impactful for a moment is coming to an end and the age of marketing domination is upon us. And I think you can read about the success of that approach every day. In twenty years people will look back at these times as dark days for science and for patients.
Bob Freeman
C. Pharma Researcher, thanks–that was an excellent summary of the impact. The only qualification I would add is the comments I frequently hear that the “lawyers are running the company.” Of course, these comments are coming from the marketing people, who are constantly pushing the envelope, to use a tired but appropriate cliche.
Doc
OIG Guidance and CIAs are cow towed to in word only. I have been to three meetings in the last 2 years where MSLs have said they objected to the marketing spin they were told to provide, BUT they did it.
Justice in Michigan
Excuse my ignorance - can someone translate MSL and CIA for me? Thanks!
Bob Freeman
Judge, here’s a quick glossary: MSL is a Medical Science Liason and CIA is a Corporate Integrity Agreement.
MSLs are field-based people who call on Key Opinion Leaders, generally academic physicians, and provide information oftentimes not product-specific information. Their purpose is to build long-term relationships for clinical research, CME, etc. MSLs are not considered sales reps and their academic backgrounds include PharmDs, MD, or PH.D.s in a basic science area. They are usually tied to a therapeutic team and report in to a regional business center and a HQ-based MSL executive. (Some pharma companies have PSLs or Pharmacy Science Liasons, but most are now called MSLs.) It is a peer calling on a peer, but, a noted, the pressure to sell (allbeit a soft sell) is always there.
A CIA is a binding agreement between the company and the HHS OIG and is the result of a the company’s violation of Medicare’s, Medicaid’s or other federal program’s pricing/reimbursement regulations. Usually a safe harbor trade practice has been violated or alledged to have been violated, and a CIA is put into effect, often for up to 5 years. It is a “bad” thing.
HorusCat
Bob,
I would add that an MSL still may be restricted in what he/she is allowed to say. For instance, where I work, the MSL is not allowed to talk about certain secondary endpoints with one of our drugs. I don’t think this is directly because of the FDA; however, the company may eventually pursue an indication, and the FDA frowns on such “preparation” of the market. So in fact, a company may restrict itself beyond what legal requirements are.
I have been to many meetings between our MSLs and physicians. 1) Our MSL doesn’t just interact with thought leaders; she interacts with anyone I take her to see.
2) Our MSL answers a lot of questions about where research is going, investigator-initiated trials, the grant process (how to apply only, she has no connection at all to the process itself), etc. One example of a recent interaction was that she talked to a physician about his desire to form a consortium of like-minded researchers and clinicians; she was able to give him the name and contact information of the director of such a consortium in another state. 3) She can answer off-label questions, but again, the company restricts her from doing so in certain cases, even though she would legally be able to answer.
HC
HorusCat
I didn’t phrase that well about the people with whom our MSL interacts. She will meet with anyone if I ask her to do so, but most of her work is done on her own, not at the request of reps. We also lean on her strongly to explain things to us about what our drugs do, because she has been a practicing MD and has used our classes of medication.
Bob Freeman
HorusCat, yes, I agree with your comments about how MSLs operate and how they interact with reps. I have also seen companies hire MSLs in work in therapeutic areas that are not part of the company’s portfolio. (At some future point the company may be pursuing the area either via licensure or in-house, of course).
In days gone by, being a MSL was a major rung on the career ladder. HC, is that still the case?
harpy
A CIA is a binding agreement between the company and the HHS OIG and is the result of a the company’s violation of Medicare’s, Medicaid’s or other federal program’s pricing/reimbursement regulations.
While some pharma CIAs are due to pricing and reimbursement violations they can result from any kind of illegal activity - False Claims and Anti-Kickback violations will also result in a CIA, usually in conjunction with a DPA (deferred prosecution agreement). The OIG guidance is really quite vague when you get down to the nuts and bolts and smart companies glean additional guidance by studying these documents. For instance - last year five orthopedic companies were nailed for Anti-Kickback violations and in their CIAs was a restriction that HCPs not receive more than $500/hour for their work. In essence this sets the upper limit for fair market value unless you have a damn good reason for paying more. Read some - they’re really interesting.
And, Bob, you put bad in quotes as if to say they are not much punishment, but having an outside agency come in and tell you how you’re going to run your business for five years, and then paying them extravagantly for doing so, can be quite galling. But - companies keep violating the statutes which is why I keep hearing the prosecutor’s say they’re going to go after the C-suite. I, for one, believe them. TAF says for every $1 the gov. invests in prosecuting medical fraud they get $15. They have the resources and they want the results.
Bob Freeman
harpy, thanks for the additional comment on other reasons a company may be under a CIA.
I regret that my use of quotation marks implied that they are not much punishment. That wasn’t my intent.
And your comment on prosecuting fraud as having a high ROI is right on target.
Justice in Michigan
Thanks for the help with the alphabet, folks. I knew the concepts but not the initials - kind of like Wheel of Fortune.
HorusCat
Bob,
Hmmm. I don’t know if it a major rung on the career ladder or not–our MSL is the mother of nine (count ‘em!) girls under the age of 20, including triplets that are about 4 years old, so I think she is happy where she is (also, I suspect chronically hypo-manic). The MSL we had prior to that was a dingbat; don’t know where she went. I think it could be career-enhancing, depending on where you want yours to go. Certainly an MSL with other business experience would be primed to move up the corporate ladder. Might be kind of nice to have someone up there with medical, field AND business experience. (I say “field” experience not in the sense of their having acted promotionally, but in the sense of having been in much contact with the field and so to be in the position of knowing the ins and outs of sales.)