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In time for the last night of Hanukkah – some long awaited (draft) guidance on social media. Well, sort of.
According to the FDA:
This draft guidance is intended to describe the Food and Drug Administration’s (FDA or Agency) current thinking about how manufacturers and distributors (firms) of prescription human and animal drug products (drugs) and medical devices (devices) can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off-label information) related to their FDA-approved or cleared products. This draft guidance updates and clarifies FDA’s policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.
“Emerging electronic media.” You gotta love the lingo.
Further:
The rapid growth of the Internet, including social media tools and other emerging technologies, has made it easier for both consumers and health care professionals to quickly seek information about medical conditions and treatments. Many firms have also used emerging electronic media to disseminate product information. As a result, firms may encounter requests for off-label information about their products through product websites, discussion boards, chat rooms, or other public electronic forums that they maintain and over which they have full control. In addition, third-party sites (i.e., websites and other venues that are either entirely independent of a firm’s control and influence or not fully controlled by a firm) also may reveal questions about off-label uses of a firm’s products. These questions about off-label uses are typically directed to users of the site at large, rather than directly and privately to firms. Such posted information is likely to be available to a much broader audience than just the original requester, especially because communication threads (i.e., questions and replies) are often available for an indefinite period of time.
This draft guidance provides FDA’s recommendations to firms wishing to respond to unsolicited requests for off-label information, including both requests made directly and privately to firms and requests made in public forums, including through emerging electronic media. FDA recognizes that firms are capable of responding to requests about their own named products in a truthful, non-misleading, and accurate manner. Furthermore, as these firms are regulated by FDA and have robust and current information about their products, FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date information about the firm’s products.
Now here’s the important part:
If a firm responds to unsolicited requests for off-label information in the manner described in this draft guidance, FDA does not intend to use such responses as evidence of the firm’s intent that the product be used for an unapproved or uncleared use. Such responses would also not be expected to comply with the disclosure requirements related to promotional labeling and advertising. Firms may choose to respond to unsolicited requests for information about off-label uses of their approved or cleared products in a manner other than that recommended in this draft guidance. Such activity would not constitute a per se violation of the law, but could potentially be introduced as evidence of a new intended use.
(Note: Bolded remarks throughout this discussion are my own emphasis.)
So, what’s the difference between “unsolicited” and “solicited?” Here’s the FDA view:
Unsolicited Requests
Unsolicited requests are those initiated by persons or entities that are completely independent of the relevant firm. (This may include many health care professionals, health care organizations, members of the academic community, and formulary committees, as well as consumers such as patients and caregivers). Requests that are prompted in any way by a manufacturer or its representatives are not unsolicited requests. Two types of unsolicited requests are addressed in this draft guidance: non-public unsolicited requests and public unsolicited requests. Responses to unsolicited requests can likewise be non-public (private) or public.
Non-public unsolicited requests
A non-public unsolicited request is an unsolicited request that is directed privately to a firm using a one-on-one communication approach.
Example 1: An individual calls or e-mails the medical information staff at a firm seeking information about an off-label use. In this case, neither the request nor the response would be visible to the public.
Public unsolicited requests
A public unsolicited request is an unsolicited request made in a public forum, whether directed to a firm specifically or to a forum at large.
Example 2: During a live presentation, an individual asks a question, directed to a firm’s representative but heard by other attendees, regarding off-label use of a specific product. This request is a public request. Similarly, a response by the firm that is conveyed to the same audience as the original question would be considered a public response.
Example 3: An individual posts a question about off-label use of a specific product on a firm-controlled website (or a third-party discussion forum) that is visible to a broad audience. The request could be directed to a firm specifically or posed to users of a discussion forum at large.
This request is a public online request. Similarly, a response by the firm that is visible to the same audience as the original question would be considered a public online response.
Solicited Requests
FDA considers requests for off-label information that are prompted in any way by a manufacturer or its representatives to be solicited. Such solicited requests may be considered evidence of a firm’s intent that a drug or medical device be used for a use other than that specifically approved or cleared by FDA. Although not exhaustive, the following examples illustrate what FDA generally considers to be solicited requests for off-label information.
Example 4: If a firm’s sales representative mentions a use of a product that is not reflected in the product’s approved labeling and invites a health care professional to request more information, resulting requests would be considered solicited requests.
Example 5: If a representative of a firm, such as a medical science liaison or paid speaker (e.g., key opinion leader), presents off-label use data at a company-sponsored promotional event (e.g., a dinner) and attendees then ask or submit requests for more information, these requests would be considered solicited requests.
Example 6: If a firm issues to health care professionals business reply cards that are intended for use in requesting off-label information, presents statements or contact information in promotional pieces in a manner that solicits requests for off-label medical or scientific information (e.g., “Product X continues to be evaluated in more than 50 trials in a broad range of conditions and patients” and “Call 1-800-… for more information”), or displays a commercial exhibit panel suggesting a new indication (e.g., a sign that reads “Coming Soon, a new use for Product X”), requests made in response to these types of prompts would be considered solicited requests.
Example 7: If a firm provides a phone number, e-mail address, uniform resource locator (URL), or username that is a word, alpha phrase, or alpha representation implying the availability of off-label information for its product, requests using this phone number, e-mail address, URL, or username would be considered solicited requests.
Example 8: A firm asks or otherwise encourages users to post videos about their own uses of its product on third-party video-sharing sites (e.g., YouTube), which may result in video postings about an off-label use of its product. If the firm’s initial request for posting of videos results in any questions about off-label uses, or if any off-label video posting made in response to the firm’s encouragement of video postings results in questions about the product’s off-label use, these questions would be considered solicited requests.
Example 9: If a firm sends out packets of information to known bloggers or online consumer reviewers and encourages them to write about an off-label use of its product on third-party sites and this then provokes a discussion about that off-label use, any requests inquiring about the product’s off-label use as a result of these blogs, whether posted as comments to the third-party site or directed to the firm, would be considered solicited requests.
Example 10: If a firm announces results of a study via a microblogging service (e.g., Twitter) and suggests that an off-label use of its product is safe and effective, any comments and requests received as a result of the original message about the off-label use would be considered solicited requests.
Example 11: If a firm sets up a website that enables viewers to read prepared standard responses for the firm’s products that are generated from prefixed pull-down menus naming various disease states, including any standard responses related to off-label uses for the firm’s product, resulting requests for off-label information would be considered solicited. Moreover, if this website makes it possible to use search terms to generate standard responses that go beyond the scope of the product information being requested, including off-label use information, resulting requests for and responses to such a search would be considered solicited requests.
For all of you out there who thought the FDA was going to answer all your questions and solve all your problems relative to social media and regulatory ambiguity, sorry. Here’s what the agency is telling you – just do what makes sense.
Or, put another way:
FDA has long taken the position that firms can respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a firm to provide information on unapproved or uncleared indications or conditions of use. If responses to unsolicited requests fall within these parameters, FDA has not expected those responses to meet regulatory requirements for promotional labeling or advertising and has not considered these responses as evidence of intended use. This draft guidance sets forth FDA’s current thinking on this topic, consistent with the Agency’s past policy statements about responding to unsolicited requests.
Now, here’s the fun stuff –
RESPONDING TO PUBLIC UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION, INCLUDING THOSE ENCOUNTERED THROUGH EMERGING ELECTRONIC MEDIA
While it certainly isn’t news, here’s the conclusion the FDA has reached regarding “the Internet” – The Internet has revolutionized communication, information-sharing, information exchange among systems, and collaboration, enabling consumers to become more proactive about their health and safety. Consequently, the Internet has become a widely used medium for manufacturers and distributors of FDA-regulated medical products to disseminate information.
So stipulated. Now here’s the interesting part
The Internet has also spawned a variety of social media tools that host online content primarily created and published by users other than the intellectual property owner or product manufacturer. In some cases, this online content may not be accurate. Because consumers increasingly use the Internet to search for information about medical conditions and treatments, firms may receive public requests for off-label information about their products through, for example, product websites, discussion boards, chat rooms, or other public electronic forums that they maintain and over which they have full control. Firms may also encounter requests for off-label information on third-party sites (i.e., websites and other venues that are either entirely independent of a firm’s control and influence or not fully controlled by a firm). Questions about off-label use may be directed to the website users at large, rather than specifically to a firm.
FDA recognizes that firms are capable of responding to requests about their own named products in a truthful, non-misleading, and accurate manner. Moreover, because firms usually have robust and current information about their products, it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are made in public forums, especially since other responders may not provide or have access to the most accurate and up-to-date medical product information.
However, because product information posted on websites and other public electronic forums is likely to be available to a broad audience and for an indefinite period of time, FDA is concerned that firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information about FDA-regulated medical products to individuals who have not requested such information. In this circumstance, communications to persons who have not requested information may promote a product for a use or condition for which FDA has not approved or cleared. FDA is also concerned about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available).
Here comes the “guidance” part of the draft guidance:
FDA makes the following recommendations to a firm that chooses to respond to public unsolicited requests for off-label information about its product(s), including those encountered through emerging electronic media.
If a firm chooses to respond to public unsolicited requests for off-label information, the firm should respond only when the request pertains specifically to its own named product (and is not solely about a competitor’s product).
The level of specificity of the question posed in a public forum is important in determining the appropriateness of a firm responding to the unsolicited request.
Example 13: An individual poses the specific question “Can Drug/Device X be used for Condition Y” in a public forum (and this question is not prompted by or on behalf of the firm). It may be appropriate for the firm to respond as outlined below because the question is unsolicited and specific to the firm’s named drug or device.
However, if an individual poses the non-specific question “What drug/device can be used for Condition Y” in a public communication thread and the firm manufactures or distributes Drug/Device X, which is not FDA-approved or cleared for Condition Y, the firm should not respond to the request because the question is not specific to Drug/Device X.
A firm's public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm’s contact information and should not include any off-label information.
The firm’s public response should convey that the question pertains to an unapproved or uncleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information.
The firm’s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication.
In other words, a post along the lines of, “Hi Bob. My name is Susan and I work for DRUG COMPANY NAME. I saw your post regarding NAME OF PRODUCT. That is an off-label use of the product. For FDA-approved indications, here is a link to the official FDA label. If you would like to discuss this product at with our medical personnel, please call this toll-free number”
Not rocket science folks. The draft guidance continues:
After an individual has privately contacted a firm for more information regarding an off-label use of the firm’s product, the firm should provide a detailed response and maintain records following the parameters outlined in Section V of this draft guidance. Therefore, any substantive communication about off-label uses for the product, in response to the original unsolicited off-label question, should occur solely between the firm and the individual who made the request. Regardless of the fact that the original, unsolicited off-label question may have been available to a very broad audience, the firm should not make its detailed response with off-label information publicly available within the same forum. For example, after the requestor has contacted the firm and provided a personal e-mail address to obtain an answer to the off-label question, the firm’s detailed off-label response, within the parameters outlined in Section V of this draft guidance, should be e-mailed to the requestor since this resulting communication will occur solely between the firm and the specific individual making the unsolicited request for the off-label information.
3. Representatives who provide public responses to unsolicited requests for off-label information should clearly disclose their involvement with a particular firm.
FDA recommends that a representative who responds to a public request clearly disclose in his/her public response that he/she is a particular firm’s representative and inform the requestor of the name of the firm representative or department to contact should the individual choose to follow up directly with the firm in a non-public forum for detailed information about the unsolicited request for off-label information.
4. Public responses to public unsolicited requests for off-label information described in numbers 2 and 3 should not be promotional in nature or tone.
In addition to a firm’s contact and disclosure information, a public response should include a mechanism for providing readily accessible current FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling or, for new animal drugs, FDA-approved client information sheet). The public response should not provide any promotional information. For example, a public online response should include a direct link to the current FDA-required labeling, if any, but should not include links to any other information (e.g., product websites, product promotional materials, firm websites, third-party websites). Furthermore, the uniform resource locator (URL) or web address where viewers are directed to obtain the FDA-required labeling, if any, should not itself be promotional in tone or content (e.g., should not be www.bestcancercure.com).
If a firm responds to public unsolicited requests for off-label information, including those encountered through emerging electronic media, in the manner described above, FDA does not intend to use such responses as evidence of the firm’s intent that its product be used for an unapproved or uncleared use. Such responses also would not be expected to comply with the disclosure requirements related to promotional labeling and advertising.
What can we learn from this draft guidance? Well, the most important lesson is that if we just follow our own common sense, social media is a greenfield of opportunity to help market products but – more importantly – to help advance the public health.
If you were waiting to be led by the hand by the "emerging social media" savants at the FDA -- sorry.
The full draft guidance is worth studying and can be found here.
And Happy Hanukkah!
But the good news is -- you ain't seen nothin' yet. (Or is that the bad news?)
In either event, thank you for your attention, comments and criticisms during the past year. And here's to a healthy, happy and successful 2012.
See you all on the other side.
Cheers.
Peter
Peter J. Pitts
Once upon a time, Paul Kim worked for both Congressman Henry Waxman (on the Energy & Commerce Committee) and Senator Ted Kenendy – giving him the honor of negotiating with FDA on the original PDUFA package and then, subsequently on the reauthorizations both on the House and Senate side.
As a panelist at CMPI’s PDUFA without the Politics conference, he had a lot to say. (A video of his full comments can be found here.) Specifically, when it came to ornaments to hang on the PDUFA Christmas Tree he had two – both aimed at enhancing and incentivizing innovation.
There are bills that even in a very partisan environment find a lot of bipartisan support and interest in a bicameral way. And there were two I just felt I had to call out. They go to the innovation gap -- an issue and a set of concerns that are so much more resonate now in this economy and the role that the agency plays in promoting innovation. There are two proposals. The first is called the Gain Act. It’s sponsored by Congressman Gingrey - Dr. Gingrey, here in the house – and Senator Blumenthal in the Senate. Wonderful bipartisanship, bicameral support there. It would enhance incentives in terms of exclusivity for sponsors that are trying to generate and create and innovate on microbials. And given the enormous challenge that microbial resistance presents to public health, this is an area where it seems like there’s a classic market failure. There aren’t enough players in the field. The marketing incentives are not strong enough to draw interest, to draw investment. So, that’s a proposal that already has bipartisan support in both chambers. I think it’s the subject of a lot of discussions in the committees of jurisdiction. So, do look out for the GAIN act as a possible ornament somewhere in the upper branches of the PDUFA Christmas tree.
The second proposal is one that has also received bipartisan support, sponsorship and interest on both sides, Senate and House. And that’s to reform the humanitarian device exemption or HDE process.
Little known, it’s kind of the lesser known sibling to the Orphan Drug Act, which has promoted and really generated tremendous innovation for diseases, rare diseases and disorders affecting 30 some million Americans. When it was originally enacted in 1990, there was a profit cap. It said if you develop a device for a very, very small population, you can only charge for cost. It was intended as a safeguard, but instead what’s happened is it’s blocked and chilled interest in using that pathway to market. The consequence is that we’ve had some 54 HDEs or Humanitarian Devices approved since 1990. In contrast, literally hundreds of orphan drugs have been approved since the enactment of that act. Again, it’s an issue that has bipartisan interest and support, a very small change to existing laws. It’s not overturning the apple cart, but I think you’ll see some significant changes in the marketplace among sponsors, investors, investigators, and scientists as a result of any federal change like that.
Some important items courtesy of the good folks at BioCentury:
Finally – a Congressional action that will lower healthcare cost:
IPAB budget slashed
The appropriations bill passed last week by Congress cut 2012 funding for the Independent Payment Advisory Board by $10 million to $5 million. The Patient Protection and Affordable Care Act created IPAB and gives it authority to recommend steps to cut Medicare costs if spending exceeds specific triggers. The recommendations would go into force automatically unless Congress overruled them by a two-thirds vote and enacted other cuts of equivalent size.
IPAB has been criticized by members of both parties. Republicans said IPAB would lead to healthcare rationing. Democrats said they oppose IPAB because it usurps congressional authority.
Understanding the importance of medical technology after-the-fact
Senators introduce device bill
Sens. Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.) and Herb Kohl (D-Wis.) introduced the Medical Device Patient Safety Act, which would allow FDA to require postmarketing studies for medical devices approved via the 510(k) process. The proposed legislation would give FDA the authority to revoke a device's approval if postmarketing studies are not conducted. Grassley said the legislation should be included in the reauthorization of MDUFA next year.
And prepare for March Madness
Supreme Court sets March date for healthcare challenges
The U.S. Supreme Court scheduled three days in March to hear challenges to the Patient Protection and Affordable Care Act, including the constitutionality of the law's individual insurance mandate. The court allocated five and a half hours spread across March 26, 27 and 28. On March 26, the court will consider a procedural question on whether the mandate challenge is barred by the Anti-Injunction Act. On March 27, the court will hear arguments on the mandate's constitutionality. On March 28, the court will consider whether the mandate, if found to be unconstitutional, can be severed from the rest of PPACA or if the entire law must be struck down. Later that day, the court will hear a challenge to PPACA's expansion of Medicaid to cover individuals with income of up to 133% of the federal poverty level.
The challenges are taken from three separate cases: National Federation of Independent Business et al. v. Sebelius, et al.; Florida, et al. v. U.S. Department of Health and Human Services, et al.; and U.S. Department of Health and Human Services, et al. v. Florida, et al.
O Tannenbaum, o Tannenbaum,
wie treu sind deine Blätter!
At CMPI’s PDUFA without the Politics conference, each panelist was asked to bring one ornament to hang on the reauthorization Christmas Tree. Tim Franson (President of the USP Convention and one of the “Fathers of PDUFA”) offered a little lifeboat.
What can we do for those with life threatening unmet needs? One thing, as was done in PDUFA IV, is adding renewal of the Best Pharmaceuticals for Children’s Act. That piece of legislation has done more for pediatric drug development than anything in the past. It’s been good for American children and it should be made permanent. I think the better policy argument is to make it permanent, because companies don’t invest in five-year cycles. (Note to reader: The Act is currently renewable every five years.)
If I’m looking for a return on an investment, I need certainty well in advance of five years on types of studies I should be conducting and I need to know the benefit I’m getting at the end. I think five years is far too short a period of time.
Here’s what Vince Ventimiglia (a former Assistant Secretary for Legislation at the US. Department of Health and Human Services) had to say when asked about renewal vs. permanent authorization:
The argument I heard when we first set the five-year term, and that I heard again when we tried to make it permanent in subsequent years, was that we want to hold these guys accountable. It’s more to use it as a tool against industry -- and hold out the prospect that it could be removed.
To which Father Franson replied:
There’s an accumulated body of evidence, of companies fulfilling their commitments. Maybe its time we make it permanent. I think this point of holding up renewal like the Sword Damocles isn’t very persuasive even to sponsors.
O Tannenbaum, o Tannenbaum!
Das soll dein Kleid
mich lehren.
(When I served at FDA we signed an MOU with PhRMA that required its member companies to inform the agency when instances of counterfeit medicines came to the attention of manufacturers. It got the job done – minus additional federal regulation.)
Shortly afterwards, Senators Amy Klobuchar (D, MN) and Bob Casey (D, PA) introduced legislation to require drug manufacturers to give “proper prior notification” to FDA when there is going to be a drug shortage.
Watch the Federal Register on Monday for an interim final rule from the FDA that requires manufacturers that are the only producers of critical drugs to report to FDA all interruptions in manufacturing processes, regardless of whether a drug shortage occurs. Previously, such manufacturers were only required to notify the agency when a drug shortage occurred. The rule goes into effect 30 days after being published.
This would have been a better and more interesting story if industry had taken the initiative rather than being directed to change its behavior.
What if we’re all wrong? What if prevention doesn’t save money?
Read Sarah Kliff’s piece in the Washington Post here.
According to Plato, “They certainly give very strange names to diseases.” Well, he clearly never encountered PDUFA -- otherwise the might have hit the hemlock too.
Ask me and I'll tell you that PDUFA ought to stand for the "Predictability Deposit User Fee Act." According to Tim Franson, one of the "Fathers of PDUFA," it means “Pharma’s Dollars Underwriting Federal Appropriations.” And when Paul Kim was on the Hill, he wanted to call it the “Giant Omnibus Drug and Medical Device Amendments Act” or GODDMAA.
Alas – cooler heads prevailed.
But PDUFA is more than just a name -- it's a philosophy. And as that well-known expert in FDA policy, William Shakespeare said, “There are more things in heaven and earth, Horatio, than are dreamt of in your philosophy.”
Well, neither the Bard nor Horatio could make it to “PDUFA Without the Politics,” CMPI’s Capitol Hill seminar on the fifth iteration of the original UFA, but many hornblowers and FDA cognoscenti did. I was the moderator and was honored to be joined by a panel of peerless nonpareils that included Vincent J. Ventimiglia, Jr (Former Assistant Secretary for Legislation at the US Department of Health and Human Services), Paul T. Kim (Former Deputy Staff Director for health policy for Senator Edward M. Kennedy), Michele J. Orza (Former Assistant Director of the Health Care Team at the Government Accountability Office), and Tim Franson (Former Vice President, Global Regulatory Affairs, Eli Lilly & Co., President, USP Convention).
The Honorable Michael C. Burgess, M.D. (Vice-Chairman, Subcommittee on Health, U.S. House of Representatives) offered remarks as well – specifically on the issue of FDA advisory committee members and conflicts of interest.
But – see for yourself. Full videos of all the presentations can be found here.
Why PDUFA without the politics? Well – watch the presentations and I challenge you to identify any of the speakers’ politics from their astute commentary on the future of the FDA.
Which is as it should be.
A study published in the Journal of the American Medical Association (JAMA) shows that Ritalin, Adderall and other drugs widely used to treat attention disorders didn't increase the risk of serious heart problems. The findings, from an analysis involving nearly 500,000 adults, come on the heels of a separate study that reached a similar conclusion about the medications' effect in 1.2 million children and young adults.
According to an article in the Wall Street Journal, “Researchers and doctors who treat the condition -- known formally as attention deficit-hyperactivity disorder, or ADHD—said that together the reports should generally allay worries about heart risk that have stirred confusion among doctors and patients for several years.”
Fears about potential heart risk for ADHD medicines were sparked in 2005 by reports of about a dozen deaths from sudden cardiac arrest among young users of Adderall. The reports prompted the Canadian government to temporarily remove Adderall from the market, though it later lifted the suspension after it was determined that the patients who had died had heart defects or other underlying heart disease.
The FDA held advisory panels to discuss the matter in 2006 and subsequently required an update to product labeling to mention cardiac risk. The American Heart Association in 2008 urged that children being considered for ADHD drugs undergo a thorough heart exam, possibly including an electrocardiogram, before taking the medicines.
The FDA and other U.S. agencies funded both the JAMA study and an earlier one published last month by the New England Journal of Medicine. The earlier study, by the same research team, reached a similar conclusion among patients 2 to 24 years old.
The study in JAMA compared about 150,000 adult users of ADHD medications between 25 and 64 years old to nearly 300,000 nonusers. Researchers reviewed medical records from four health insurance plans to look at the number of serious cardiovascular events such as sudden cardiac death, heart attack and stroke among both groups.
Despite the findings, the FDA said Monday that patients treated with ADHD medications should continue to be monitored for changes in heart rate or blood pressure as well as for other side effects that include decreased appetite, weight loss and trouble sleeping. The agency also said the drugs "should not be used by patients with serious heart problems, or for whom an increase in blood pressure or heart rate would be problematic."
In August 2005 I had the opportunity to interview Newt Gingrich on a variety of healthcare issues. The questions and answers are as fresh as if we spoke this morning – and perhaps even more relevant considering the Speaker’s current position as one of the Republican front-runners.
Peter Pitts: Hello Mr. Speaker. Thank you for taking the time to chat with me.
Speaker Gingrich: I’m delighted to have the chance to talk with you.
Peter Pitts: Mr. Speaker, a lot of people talk about personalized medicine – but what do you think we need to do to make it a reality?
Speaker Gingrich: In the long run, it’s going to involve DNA data because there are so many things we can learn, particularly with regard to cancer. In the short run, it’s already starting to evolve. Take a look at the iHealth record product, for example, where you could keep your personal information and send it to a doctor using encrypted email. It’s an example of a baby step in the right direction. I just saw a diabetes cell phone that is being developed in Korea and has actually been submitted to the FDA. It will allow those who have diabetes to monitor their condition on a cell phone, send the data to their personal health record and to their doctor, and even schedule a set time to remind them to check their blood sugar. It sounds like a bit of magic, but it’s all coming down the road right now.
Peter Pitts: Do you think that pharmaceutical companies have the economic models to make personalized medicine a reality, and does the FDA have the tools to review them and approve them?
Speaker Gingrich: Part of the reason why we are going to see more personalized, narrowly focused drugs by both pharmaceuticals, and even more important, biotechs, is that we are now entering a period where drug companies will be able to reach you in a targeted way. When a drug company rolls out a drug to certain people, it has to go to every doctor’s office in the hope that it will find the 12 doctors that actually need the specific drug. But if it can actually target electronically – for example, because we actually have electronic records now, we could contact directly the 30,000 people who are on Vioxx the morning there was a problem. That’s the kind of step towards the model that I am describing, where you would know that there are x number of thousand people who have Lou Gehrig’s disease, and you can reach them instantly without an ad campaign. You could also reach the doctors instantly and therefore, you would actually dramatically increase the net value of certain drugs because you would so dramatically lower both the loss time and the distribution time.
Peter Pitts: What would be the broad implications for that in terms of changing the overall health care model – to evolve from an acute care model to more of a chronic care model?
Speaker Gingrich: Well there is a difference, let me draw a distinction here. In acute care, you’re going to get more rapidly focused, narrow delivery of precisely what you need for your acute problem. A chronic condition will require lifetime management, which in some cases could mean diet, exercise, and attitude. In other cases, it will be the application of appropriate medications. It will be less profitable per unit, but there will be massively more units. Businesses will either use traditional acute care or orphan drugs.
Peter Pitts: How do you get physicians and patients in the mindset that they can be cared for individually and precisely, as opposed to waiting until something bad happens, then go for treatment?
Speaker Gingrich: Well part of it is an incentivization program. I’ll give you two examples. I was just at Des Moines University in Des Moines, Iowa, where they actually gave bonuses to faculty and students for being compliant on exercise, blood pressure, and the management of diabetes. It’s a terrific program. And they are beginning to have real impact because people are focused on their own behavior. I also know that in the Mercy Health system in St. Louis, 76% of the blue-collar workers in a factory signed up for a personalized contract and an incentive plan – 93% of their diabetics are compliant. So those are examples of focused incentives.
We are working in Georgia with 14 corporations and state government to begin to put together a Bridges to Excellence diabetes program that pays the doctors $100 in advance for managing diabetes. With the patients in Cincinnati and Mobile, they’ve been saving about $150 a patient for a net of $250 per patient per year by incentivizing the doctor. We believe that if you combine that with incentivizing the patient, you’ll get an even better response. And with this new diabetic phone, you are going to get dramatic improvements in compliance.
Peter Pitts: That’s an interesting point – the convergence of technology on the one side, and drugs and biologics on the other. On the technology front, what role will medical devices or medical technology inside the body play in the future?
Speaker Gingrich: I believe almost certainly, in the next decade, you’ll have the equivalent of a pacemaker/cell phone. Your pacemaker will call 9/11 before you know anything is happening. It will also send routine monitoring data. I’m sure you’ve seen the shirts people wear that automatically keep track of vitals. What will happen at one level is that all of this will become ubiquitous invisibly. You won’t notice, but it will be constant. It will involve medicine with a wireless capability and a massive bandwidth, matched up with expert systems that analyze data. Some of this is happening now.
A facility in Oregon now puts a GPS locator on a band on Alzheimer patients’ arms. They can walk all over the area without having to worry about getting lost. They have wired their beds in such a way that the staff knows when they are laying down and sleeping soundly. If they have a walker, the walker is wired. If they can go to bed and in the middle of the night, go to the bathroom and later their walker doesn’t move, there is a presumption that they fell down and within two minutes the nurse comes to check. It’s a very fascinating place and I strongly recommend that you look at it. It’s an example of some of the things that you are asking about.
Peter Pitts: That’s definitely going to avoid a lot of problems and a lot of complications down the road. What can the FDA, the National Health Institute, or the Centers for Disease Control, or government in general do to help?
Speaker Gingrich: Well, you have to remember that government is the largest payer. It’s up to the government to make purchases intelligently, and to incentivize. It’s up to the government to help incentivize patients with Type II diabetes. It’s up to the government to transform Medicaid, and to have the discipline of change. That’s part one. For part two, it’s up to the FDA to accelerate the introduction of entrepreneurial new products that are not life threatening. The diabetes phone may be one of these examples. You want to have very rapid flow of approval for things that are relatively easy to do.
Peter Pitts: And for those areas where approval doesn’t exist, how can the FDA reform itself to make that happen?
Speaker Gingrich: Part of it is changing minds and to say, if we don’t believe that there is something significantly dangerous about this, the bias should be in favor of approving it. When you get to a very sophisticated electronic health record system with expert analysis, you’ll be able to approve things more rapidly because if something goes wrong, you can recall them more decisively. So that increases the level of risk you can take.
Peter Pitts: The pharmaceutical industry is in such a hole right now in terms of their reputation, what can it do to dig itself out of the hole to become a more positive player?
Speaker Gingrich: I think it should be clear to the pharmaceutical industry that they should focus on reaching and linking to an electronic health system, rather than producing massive commercials. If you look at the amount of money they spent on commercials in the last two years, you could probably provide an electronic health record for every person in the country. I think the more people see the pharmaceutical industry genuinely worried about people’s health, the better off we are. Second, I think the more we can move to a Travelocity model of selling drugs, where you have full information, know the strengths and weaknesses of each drug, what the side effects are, and the pricing, you are more in control. I think that would dramatically improve the image of the drug industry and give people a sense again that they are in charge as customers.
Peter Pitts: That’s an interesting concept, to have the pharmaceutical industry adopt and fund electronic records for all Americans.
Speaker Gingrich: If you look at what Pfizer is doing in Woodbury, Connecticut, they are in fact sponsoring information technology health care in that town. I think if the drug companies are focusing on reaching the customer in an informed way, designed to maximize health rather than profit, people would, in fact, understand that and be responsive to it.
Peter Pitts: What’s the big idea to reform health care in this country?
Speaker Gingrich: Well, I don’t know that it’s a single big idea. We propose a Twenty- first Century Intelligent Health Care System. We propose three very large changes. First, moving away from acute care to focusing on wellness, prevention, and early detection. Second, from focusing on the provider, to focusing on the individual, so we get you involved in your health before you ever become ill. Third, that we take advantage of information technology, so that we maximize productivity, accuracy, speed – what people see everyday in other aspects of lives. We think those changes together really would make a dramatic difference in both saving lives and saving money.
Peter Pitts: How do you get Americans involved in their health care when they are not ill?
Speaker Gingrich: By moving to Health Savings Accounts and Health Reimbursement Accounts – when you start getting bills, you start getting directly involved. Second, if we should have a right to know pricing and quality legislation -- 93 percent of the country likes the idea of knowing the price and quality before making decisions. I think the country is ready for change, but the politicians aren’t. And I think 80 percent of the country favors electronic private health insurance for example.
Peter Pitts: What does your crystal ball tell you about legislation and price controls?
Speaker Gingrich: I think price controls are such a stunningly dumb idea. It has failed totally almost everywhere in the world. It has ruined the research components of pharmaceuticals in Canada. The danger is that if we don’t move to a Travelocity model of individual control of purchasing, somewhere down the road, the government will start setting prices for what it pays for health care just because the prices are so staggering. For four thousand years of recorded history, when politicians have to choose between their own survival and your property, they choose your property and their own survival.
Peter Pitts: That’s interesting, so basically replacing the debate over price with a practical movement forward in personal involvement. Thank you.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
