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Obama vs McCain: Impact on HHS and the FDA in the Next Administration
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Obama vs McCain: Impact on HHS and the FDA in the Next Administration
Posted 10/27/2008

http://www.medscape.com/viewarticle/582553?src=mp&spon=43&uac=52149SZ


Mary Pendergast, JD; Marc J. Scheineson, Esq, JD; Michael McCaughan; John Kamp, JD, PhD;
Destry Sulkes, MD (Moderator)


GET THE FACTS: There are many opportunities for conflict, bias, misrepresentation of facts and misinformed perceptions when people form a position around a specific issue or policy. This has been the case with respect to recent publications concerning conflict of interest and bias in Continuing Medical Education (CME). Read what the National Task Force on CME Provider/Industry Industry Collaboration is doing to mitigate these perceptions.



Source: National Task Force on CME Provider/Industry Collaboration. Get the Facts: Conflicts of Interest and Bias in CME.


Transcript

Destry Sulkes, MD: Hello, I'm Dr. Destry Sulkes, Vice President of Education Strategy here at Medscape LLC. I'd like to introduce to you John Kamp, who is on our CME Advisory Board. He also serves as the Executive Director at the Coalition for Healthcare Communication and, finally, serves on the program committee for the AMA Task Force. Today, he moderated the opening session on the future of the FDA and HHS under the next administration. John?

John Kamp, JD, PhD: I want your listeners to listen to this panel that's coming up because there's some very important information there for them. The people on this panel have been in the administration of the last few Presidents, and they know the FDA, they know the HHS, and they know the context in which these decisions, that will be very important to all of us around all of healthcare, including CME, will be made. One or two of these might even be in the next administration. We don't know that yet because we don't even know who is going to win the election, for sure anyway, but this panel contains a lot of good information for all of your listeners.

Dr. Sulkes: Thank you, John. Please stay tuned for the panel discussion coming right up.


Introduction of Panelists

I would like to welcome you to another broadcast of Medscape's Continuing Education Forum. Today's session is intended to address the upcoming election and is entitled, "The Future of the FDA and HHS Under the Next Administration and the Impact on CME." Our specific objectives today are to address: (1) what to expect from the next leaders of FDA and HHS; (2) how the post-election environment will affect CME; and (3) what the most important changes will be in healthcare outside the CME realm.

As a reminder, although our broadcast is being recorded on site here in Baltimore, Maryland, at the 19th Annual Conference of the AMA National Task Force on CME Provider and Industry Collaboration, the views expressed are solely those of the individuals. So, let me introduce my distinguished colleagues. Welcome. Today we have Mary Pendergast, President of Pendergast Consulting and former Deputy Commissioner and senior advisor to the Commissioner of the FDA. This is during both Democratic and Republican administrations. Welcome, Mary.

Mary Pendergast, JD: Thank you.

Dr. Sulkes: We also have Marc Scheineson, partner, Austin and Byrd, and former Associate Commissioner for Legislative Affairs of the FDA during a Republican administration. Welcome, Marc.

Marc Scheineson, JD: Thank you, Destry.

Dr. Sulkes: Thank you. And finally we have Mike McCaughan, Editor in Chief of the RPM Report and the Pink Sheet. Welcome, Mike.

Michael McCaughan: Thanks, great to be here.


Obama vs McCain

Dr. Sulkes: Excellent. So my first question for you all is what would be different vs what would be the same under Obama as compared to McCain administrations? Who would like to start?

Dr. Pendergast: Well, I think one thing that will be the same, in both administrations, is that they'll have to get a stronger handle on healthcare costs. I think that this is something that is looming. It's going to be affected by the financial crisis that the country is going through, and so I think both administrations will try to look for ways of saving healthcare costs, even while trying to insure more people.

Dr. Kamp: Right, there are a lot of things that will be the same because the Congress just passed a major overhaul of FDA, for instance, and the FDAAA [Food and Drug Administration Amendments Act of 2007]. The FDAAA requires a lot of drug safety monitoring, a lot of post-market surveillance, and almost a dozen sets of regulations that the FDA is going to be busy trying to write and adapt.

They'll be different in the context of oversight and review of some pharmaceutical manufacturer practices, such as direct-to-consumer advertising and promotion of pharmaceuticals. They'll be looking at ways to either scale that back, increase the amount of information the consumers receive, or at least disclose industry funding of those sources.

Dr. Sulkes: Thank you very much. Mike?

Mr. McCaughan: I agree with both Marc and Mary, and I would say, clearly, on the campaign trail, Senator Obama has really been emphasizing healthcare reform as a theme, and that suggests that there would be a difference in how the 2 administrations would approach that issue. That being said, to Mary's point, there's complete agreement, as far as I can tell, on the cost of the healthcare system being a priority. It's interesting to me that Senator McCain's advisors on healthcare tend to be economists. That actually seems to be where most of the healthcare policy is being driven there, and there's actually a great deal of agreement at that level, between the 2 campaigns. I also think, from the Obama campaign side, clearly the fiscal crisis is changing peoples' thinking about what you can and can't accomplish. Their argument will be that healthcare is an economic priority. I think maybe in a McCain administration, there'd be a much stronger argument that the economy is the priority issue, and we need to deal with that first.

Dr. Kamp: And one other point -- as Michael says, cost is such a fundamental agreement between both, and the one role that FDA has in cost, obviously, is in admitting generic drugs into the marketplace. When a generic comes to the marketplace, the cost tends to go down because of the increased competition. There will be an emphasis to get generics reviewed and approved more quickly, and focus on how to get biologics, which don't have generic competitors now, biosimilar or biogeneric products, and create a pathway to do that.

Dr. Pendergast: I think that there's a fair amount of agreement that there should be a pathway for creating "generic" biologics -- or, because there is no such thing as generic biologics, similar biologics. I think the issue right now will probably be given to Congress to figure out or to compromise on how much time the pharmaceutical companies, that did all the work and research on the biologics, get as compensation for all the work that they did. I think everyone would like to see a pathway going forward.

Mr. McCaughan: Right. The biggest problem with biogenerics, of course, is that unlike molecules, no biologic product is exactly the same. They're all human proteins and human genes. And it's just much more difficult to develop and prove that they have the same action as the innovator products.

Dr. Pendergast: An area where there may be some disagreement is in stem cell research. An Obama administration may be more supportive of that than a McCain administration.

Senator Obama has introduced legislation with respect to food safety, so I think in terms of the United States protecting the public from food-borne illnesses, that will be an area where he may want to focus in his administration.

I also think that Senator Obama has expressed his support for personalized medicine and for helping find diagnostic tests that can help figure out which people should take a drug because it will be particularly effective for them, or which people shouldn't take a drug because they're at increased risk for adverse events. There will be more activity on that front if Obama comes in than if McCain comes in.

Mr. McCaughan: I'll just chime in to say that I think another very important point to bear in mind is that so much of the campaign has been about the last 8 years and the legacy of the current administration. When you look at that in the window of the biopharmaceutical industry, the last 8 years were really about as good of a political climate as they could have had to operate in. I think the expectation, at least within the industry, is that no matter who the next administration is led by, it's not going to be as open to their ideas of how innovation is to be encouraged; it's going to be a worse climate for the biopharmaceutical industry regardless of the outcome of the election. Neither candidate has distinguished themselves by suggesting that they would be friendly to the pharmaceutical industry, both have been willing to attack, and I think that's an important point of similarity that people should expect going forward.

Dr. Sulkes: That's actually an interesting point that you brought up earlier today around David Kessler's role during his tenure as Commissioner of the FDA and what happened. Could you address that please?

Mr. McCaughan: Sure. David Kessler, of course, was the FDA Commissioner appointed under the first President Bush. He came in at a time when FDA's credibility was perceived to be very low. His first activities were to really ratchet up enforcement, make some high-profile examples out of people, companies, get a lot of attention, and re-establish the FDA's credibility.

What followed from that was some really major new legislation and changes within FDA that actually led to many more drug approvals. It's conceivable to me that we would see a replay of that, regardless of whom the next administration is. I would expect the next commissioner to take a tougher line, declaring themselves independent of industry, and that does, in turn, perhaps lead to an environment where you can end up with more drugs being approved and entering the market.

Dr. Kamp: And that could well happen, and we both worked for David Kessler in different administrations, but it was a different time when David Kessler came into office. I don't know if the viewers remember, but the generic drug scandal had just hit, where generic drugs were being approved but they were fraudulently comparing themselves to innovator products.

Mr. McCaughan: That's such a different time.

Dr. Pendergast: I was going to say we're experiencing that again.

Mr. McCaughan: So the story repeats itself.

Dr. Pendergast: I think that the next administration ought to, and I would think that Obama would -- I'm not so certain about McCain -- actually make an effort to re-establish the FDA's credibility. The FDA, for the last 8 years, has not been aggressive in enforcing the law. It has ratcheted back some of the public health protections that existed prior to the Bush administration. I can see the next Obama administration enforcing the law more rigorously.

So, for example, if there was another heparin problem, where people died, I think you would find the next administration will hold some company accountable for that situation instead of just letting it slide. I think that we'll see more of that in the next administration. Hopefully, if there's a strong commissioner, the FDA will feel as though it has the support of a strong commissioner to make tough decisions. I think, right now, the FDA's afraid of making tough decisions because there's not much of a backstop for them, in this time at the moment, and they can be buffeted about and criticized by Congress. Hopefully with a strong commissioner, FDA will be able to make tough decisions, stand behind those decisions, and move forward a little better than they've done in the past.

Dr. Sulkes: Very interesting paradox then that you're all discussing.

Dr. Scheineson: I think the unstated assumption behind the question is that the leadership in Congress won't be changing. Of course we don't know that for certain today, but I assume the assumption we share is that it will still be a Democratic Congress that FDA has to answer to.

Dr. Pendergast: I think it's fair to say that the FDA sometimes is a political football. When you have Democrats in Congress and a Republican head of the FDA, it is easier to criticize the FDA than if there is a Democratic [majority] in Congress criticizing a Democratic head of the FDA. I think that there may be some of that, but the FDA has been getting criticized by both Democrat and Republican members of Congress. There will be equal opportunity criticism.

Dr. Scheineson: My last point is one that I think we can all agree on: Whoever the President is, there needs to be an FDA commissioner appointed and confirmed as quickly as possible. There have been too many occasions where the agency has drifted because of an acting commissioner or no appointee at all. I think it's a time, especially with safety of food and drugs, that [appointing an FDA commissioner] should be a priority of any new administration.


HHS and FDA Implications

Dr. Sulkes: Excellent, thank you. So let's jump, actually, to the FDA and HHS. My second question is what specific changes to do you see within HHS and FDA under the incoming administration?

Mr. McCaughan: I think we've started down that path already, but its an interesting question. There will obviously be a new FDA commissioner. There's the theoretical possibility that Commissioner Von Eschenbach would stay on. I think that's fairly unlikely under the circumstances, so my assumption would be that there will be a new leader at FDA, and that person will obviously make a difference.

Historically, there's a lot of process in getting the commissioner in place. One of the big changes is that now maybe the Securities and Exchange Commission or the economic advisory boards of the government will suddenly be a higher priority. There is the possibility of maybe, despite what Marc said, that we will end up with a protracted period between the new administration and who that new head of the agency is.

Dr. Scheineson: The interesting question is going to be what the flow over between the financial crisis that the country is facing and a perception that the fox wasn't guarding the hen house or that regulations were either inefficient or not being enforced, and how that will flow over into the healthcare sector. Is that going to be a general perception? As you know, the drug and medical device industry is not exactly unregulated; it's a highly regulated industry.

Dr. Kamp: The most regulated, right.

Dr. Scheineson: There will clearly be a lot of oversight, and I think we've seen that in the current Democratic Congress. The FDA frequently is an agency that has a broad jurisdiction, regulating a quarter of the American economy. But it doesn't have the resources to keep up with that. So whatever commissioner, whatever administration or secretary of HHS comes in, they're going to have to prioritize to decide what those priorities are. In essence, some of that was set by Congress in the new reform legislation that passed in 2007, and the question is, will that be all they can do with their priorities or how will they use the limited resources they have?

Dr. Sulkes: Can you speculate on the next HHS secretary under a Democratic administration? I've heard some ideas around the Republican candidates, but what do you think about a Democratic administration? Who do you think are the more likely candidates?

Dr. Scheineson: My law partner is Tom Daschle, who has been a very close confidant and a very active advisor to Obama. He's just released a very well-read book on healthcare reform in which he advocates for a Federal Reserve board for healthcare that would sell insurance like the federal healthcare plan that Congressmen and Senators enjoy. It's the gold standard healthcare. I think by virtue of that position that he would have to be a candidate for that position, among many. The HHS secretaries are often governors or senators.

Dr. Pendergast: I agree that I think former Senator Daschle would be a very excellent pick, although I've heard his name bandied about for a number of different positions in an Obama administration, so it's hard to say.

I think a former governor that could be considered is Howard Dean, who is a doctor and both understands the department's issues from the doctor's point of view and from a governor's point of view. I read yesterday that Maine is spending roughly 31% of its budget on healthcare costs under Medicaid. Well, you can understand the governor's incredibly great burden as we face these healthcare costs .I would anticipate the person that's the next head of HHS would be a person that could help lead healthcare reform in an Obama administration, and even if it isn't sweeping reform, lead some effort to reduce healthcare costs through innovative ways.

Dr. Sulkes: Thank you.

Dr. Scheineson: I think that's great, and I think that Mary made an excellent point earlier that one of the top leaders in the new administration would be expected to be an MD, a doctor. The recent pattern has been to perhaps have a governor, someone like that running HHS, and let someone at FDA be the MD, but it's interesting to wonder in an administration where Howard Dean, with a medical degree, was an HHS secretary, then you could certainly have different types of people for all the other jobs that flow under there.


Impact on Industry and CME Funding

Dr. Sulkes: Thank you very much. Now I want to switch gears a little bit and go more specifically into the CME and education realm, and ask my third question, which is what is the impact that the new administration would have on CME and specifically should we expect changes in commercial support for CME or other changes in regulations, such as the FDA guidance on CME from 1997?

Dr. Pendergast: I'm not so sure that the FDA guidelines from 1997 will change, but I think that there is an evolving pattern of desire across many different sectors to have more openness and a greater understanding as to who is doing what and how they're being paid. Companies are putting on their Websites which positions they're paying and how much they're paying them and for what purpose they're paying. I would anticipate that kind of openness in an effort towards controlling conflicts of interest to permeate the continuing medical education arena going forward.

Dr. Sulkes: Very different.

Mr. McCaughan: And I agree with Mary's points; there's pro and con here, obviously, and a perception. The perception is that for some reason, because of the resources of pharmaceutical manufacturers, that they have undue influence in how education is being disseminated. The pro, obviously, is through those resources, if they're unrestricted grants or have other independence, you're able to have much more CME and you're able to educate providers in these new and emerging technologies in a much broader fashion. The con obviously is just education on a certain drug, which is a sponsor's drug. There are already numerous controls, as we all know, in the current law. There's also a cop that's on the beat very aggressively now. FDA may not have to do it because it acknowledges in the guidance and other standards. It recognized voluntary standards, such as those set by accrediting organizations like ACCME; and, as we all know, ACCME has defined commercial interests in a very broad way and is actually moving in some realms to confine CME to academic institutions and not even have commercial providers grant CME at all. So, there a cop on the beat, they're using their authority pretty dramatically. The question is: will the FDA have to act at all?

Dr. Sulkes: Thank you, Mike.

Dr. Scheineson: From the stand point of FDA, I think they have so much on their plate that some self-initiated action addressing CME seems, to me, to be very unlikely, but there's a bigger picture here, which is that I don't know any politician who stands up and says they think pharmaceutical companies should market more aggressively and spend more money to market their products. I do think there will be a lot of enforcement activity, even more than we've seen, whether it's coming from the Inspector General's office in the Department of Justice, directly from FDA, or elsewhere, over marketing practices, being broadly defined. I think areas like direct consumer advertising are probably much more tempting targets, but in that kind of a climate the perception of industry taint or bias is toxic, and if a situation leads into the world of CME as being perceived as a big problem, there would be almost unstoppable action. I do think other targets would be more tempting for the people who would be making those choices.

Dr. Pendergast: I also think that pharmaceutical companies will be taking a hard look at how much money they spend on continuing medical education, and they're going to have to reassess their own calculus as to whether or not that's the right place to spend money. So, I think that pharmaceutical companies are seeing a downturn in sales; during an economic downturn, people tend to not fill their prescriptions. There will be fewer sales. There are a lot of drugs that are going to become generic over the next 4 years. So, again, those are dollars that leave the major pharmaceutical companies' pockets, are the ones that pay for CME and go to the generic companies, and they don't pay for CME. So, you've got a good question as to whether the same number of dollars will even be devoted by the pharmaceutical companies to continuing education, and if that happens, I don't know how that will roll out and impact the industry. But it's something you should be looking for.

Dr. Sulkes: Thank you, Mary.

Dr. Kamp: I'm guessing that CME is not on either of the presidential candidates' radar right now. I think both candidates, as has been said, are conscious of the price of medical products to the extent that they think funding or grants for continuing education increases the price of the products that are sold. I think there would be some interest in the White House, but I would guess that given all the issues the new president will have to face, this one will not even be in the first term.

Dr. Sulkes: Fair enough. Also, I've heard a few of you speak about the value of medications and the outcomes, given what the cost is of the medication. Do you have any perspective on how the new focus on value may be translated through CME vehicles?

Dr. Pendergast: Well, I think to Marc's point, it's not the price of things that is the most worrisome, it's the overall cost of the treatments. So, you might have an expensive drug, but it's offsetting a more expensive surgery. The overall cost is lower even though an individual item's price is high. I think that everyone that is sophisticated is looking at this more in terms of overall cost than the actual price of things, but I could be wrong about that.

CME, I think it could be helpful if there was or if there becomes better information about the best way to practice medicine that could be communicated through continuing medical education providers. I think that CME could be much broader than just learning about the newest drug.

Dr. Sulkes: Right, thank you.

Dr. Scheineson: And the value of pharmaceuticals; no one will deny that the plethora of approvals that have occurred in the last 10 years will revolutionize medicine and have reduced hospital days and have allowed patients to care for themselves in a much more dramatic manner. A lot of those drugs are complicated drugs, and a lot of the devices that are coming on the market are tremendously complicated, so much to the extent that physicians need to be trained how to use them. You can't be penny wise and pound foolish in that respect, and I think the administration would know that.

The other point there is that continuing medical education dollars have to come from somewhere, and they're clearly not going to be coming from the government in this time when deficits are at record highs and with more expected. I think you have to go where the money is and buy through disclosure and though independent criteria, which both agencies, OIG and FDA, enforce. I think pharmaceutical dollars are still going to be what fund the lion's share of CME.

Dr. Sulkes: Thank you. Mike?

Mr. McCaughan: I would suggest that there will be a real push towards some kind of national comparative effectiveness effort, probably no matter who prevails in the campaign. It seems to me that if there is, whether it's an entity generating more data, comparing different types of treatment or simply certifying our sources of data, that helps make the case that there's real value in educating prescribers and providers on what those data show. So it seems to me that there's a great opportunity to do interesting things to CME there.

I also suspect that in many cases there will be a great economic interest for a company to support those guidelines, and in other cases maybe it will be payers or providers or other groups who might need to step up and see an interest in funding it. I do think there is a nexus there, but it's probably going to take a number of years before we see anything on a federal level that actually has any credibility in terms of driving that kind of research.

Dr. Pendergast: I have to admit, I'm cautious about comparative effectiveness for pharmaceuticals. If you look at it, there is no pharmaceutical that works for all the patients that are treated with the drug. People need a variety of drugs because people react to different drugs differently, and as we learn more and more about the genetics underlying the effectiveness or the safety profile of a drug depending on who the person is and what their genetics are, I think that you've got one train running towards comparative effectiveness, saying, on a population basis, this is the drug that's best for the most people, so everybody should use it. But personalized medicine says no, let's find the right drug at the right dose for the right person. I think that those trains will collide.

I think the one thing I would like to see is for FDA to not become the comparative effectiveness arbiter, but rather take a stop back and make sure that every drug that's out there is safe and is effective and then let physicians have the opportunity to choose amongst those drugs for that individual patient. Because we're treating patients one by one, we're not treating populations. So I think that's an important thing to be thinking about.

Dr. Sulkes: Thank you, Mary.

Dr. Scheineson: And, Destry, the law on comparative claims isn't very favorable to FDA to even be able to make those judgment calls. FDA takes a position that unless a drug is compared in a head-to-head trial with those other medications that are adequate and well controlled, you can't even make a comparative claim in the market place. The question is who would make those comparative claims? Manufacturers are going to be prohibited from doing that. If the government's going to try to do it, they know less about the drugs than the makers of those drugs; it would be a very questionable proposition.

Mr. McCaughan: It would, maybe, just as a final thought and back to Marc's point earlier, both Marc and Mary's point, in fact, there are so many more sources of data and information about products when you think about personalized medicine, the complexity of the data, when you do large studies, comparing treatments, it does seem to me that the world is moving towards more and more and more data about medical interventions, and I suppose it's an important job for someone to educate the providers on how to make sense of it.

Dr. Sulkes: Well, on that note, folks, thank you so much for joining us today and providing your perspectives, especially talking about education at the end there, I appreciate that little plug. That's all we have time for today, folks. On behalf of Medscape, I would like to thank our panelists again for joining me in this stimulating discussion. I would also like to thank the audience for tuning in to the program, and stay tuned for the next broadcast of Medscape's Continuing Education Forum.


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