May 23, 2012 – At an FDA meeting held last week to explore more effective ways of including patient input in regulatory decisions regarding drug, device and biological products, the agency made it plain to patients, caregivers, patient advocates and patient advocacy groups that it wants patient perspectives to be included in the process.
“This initiative, led by Center for Drug Evaluation and Research Director Janet Woodcock, M.D., is the second of two ‘game changer’ proposals that put consumers and marketing at the center of the discussion, and potentially at the center of the drug approval and use processes,”
said Coalition for Healthcare Communication Executive Director John Kamp, who explained that earlier this year, Woodcock began a discussion about the creation of a third class of drugs where initial prescriptions and refills could sometimes be filled without a physician (http://www.cohealthcom.org/2012/04/30/proposed-otc-drug-distribution-would-expand-patient-access/).
“Together, these proposals mean that FDA is fully recognizing the power of the patient and putting patients at the center of health care in America,” Kamp said.
In a notice published before the May 18 Inaugural FDA Patient Network Annual Meeting, the FDA stated that “establishing a means for obtaining input from patients and patient advocate groups will allow FDA to further enhance its benefit-risk assessment in regulatory decisionmaking.”
Further, the agency said that “patients who live with a disease have a direct stake in the outcomes of the review process and are in a unique position to contribute to the weighing of benefit-risk considerations that can occur throughout the medical product development process.”
At the meeting, CDER’s Woodcock noted that in general, regulation is “the result of a societal consensus that limits the actions or speech of certain parties in society.” She added that although science can inform risk-benefit decisions, it “doesn’t tell us if the benefits outweigh the risks. That’s a value judgment.”
The FDA set forth junctures in the drug approval process where it believes that consumer/patient input would be most valuable: (1) the pre-Investigational New Drug (pre-IND) stage and (2) the pre-New Drug Application (pre-NDA) stage. Input during the pre-IND period is important, according to CDER officials, because such input would fill information gaps about treatment benefits for specific conditions. At the pre-NDA stage, patients could provide input regarding the new therapy’s effectiveness and tolerability.
It appears that patient input also would give the agency additional information about which treatments – drugs or other modalities – are available to and working for patients. This information could help the agency enhance its value judgment-making capability.
“Acetaminophen … very rarely causes devastating liver failure, and some people say that even a rare risk is unacceptable,” Woodcock said. She explained that knowing more about a drug’s impact on a population can help the agency with its decisions, citing a multiple sclerosis treatment that helped many patients but potentially could put certain individuals at risk of progressive multifocal leukoencephalopathy. “The MS community rose up to help keep this drug on the market,” she said.
The agency currently is preparing a list of 20 diseases/conditions for which it will gather patient input under the Prescription Drug User Fee Act V. Incorporating patient perspectives into the regulatory review process is a “major task for FDA over the next several years,” according to Woodcock.
“At this juncture, we need to work together,” she said. “The bottom line is to improve the diagnosis of illness and alleviate suffering.”
Sept. 16, 2011 – Trying to assess industry adherence with FDA advertising and promotion regulations is a tricky endeavor, according to an article posted today in Policy and Medicine. The article, “Study Shows Adherence to FDA Advertising Guidelines Are in the Eye of the Beholder,” states that although there currently is no “systemic assessment of physician-directed advertisements to FDA regulations in the last 20 years” and a study of smaller sample size has limits, the best approach to improving compliance under a modest DDMAC enforcement budget may be “more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.”
To read this article, in which Coalition for Healthcare Communication Executive Director John Kamp is quoted, go to: http://www.policymed.com/2011/09/study-shows-adherence-to-fda-advertising-guidelines-are-in-the-eye-of-the-beholder.html
Pitts: BIO’s Call for Drastic Regulatory Change Is On Point
June 27, 2011 — In a recent blog entry on DrugWonks.com, Peter Pitts commended BIO’s proposals to revamp the U.S. regulatory system for new treatments and therapies. Pitts mentions that BIO’s plans, as reported in BioCentury, include a progressive approval pathway for unmet condition therapies, a fixed term for the Commissioner of Food and Drugs, a redefinition of FDA’s mission and the FDA as an independent agency, separate from the Department of Health & Human Services.
Read more on the DrugWonks.com Web site
June 16, 2011 – The Food and Drug Administration (FDA) should not mandate comparative effectiveness trials as part of the drug approval process, according to Scott Gottleib, a resident fellow with the American Enterprise Institute for Public Policy Research (AEI).
Gottleib, a former FDA policy head, writes in AEI’s June issue of Health Policy Outlook that the FDA should not bow to the pressure of consumer groups that are calling for across-the-board comparative effectiveness trials be added to the drug approval process, noting that these trials already are being conducted in important cases. Requiring these trials for all drugs would significantly slow down drug approval reviews, he asserts in the article. Read the full AEI Guest Column.
Immediate Guidance Slips Again
May 9, 2011 – A recent notice in the Federal Register calling for comments on a series of Food and Drug Administration (FDA) studies to determine the most effective way of presenting risk information online indicates that the FDA is still a long way from developing significant new social media guidance. This status leaves industry in an unsurprising state of limbo after the Division of Drug Marketing, Advertising, and Communications (DDMAC) missed at least two self-imposed deadlines for issuing draft guidance and did not set a new target date for the much-anticipated document.
“The FDA’s choice to start new studies rather than issue guidance is unfortunate,” said John Kamp, executive director of the Coalition for Healthcare Communication. “Healthcare providers, patients and care givers are on the Internet, searching and finding health information. Companies, knowing that much Internet health information is uninformed and biased, must participate even without FDA guidance,” Kamp asserted.
The agency states in an April 28 Federal Register notice that it plans to research the new venues available online for displaying risk and benefit information for prescription drug ads in a fair and balanced way.
According to the FDA, “The interactive nature of the Internet allows for features not possible with traditional media … such as scrolling information, pop up windows, linking to more information, and embedded videos.” The agency is planning a series of studies that test the different methods of risk and benefit information on branded drug sites, the results of which will “inform the development of future guidance.”
Study 1 will examine the visibility of risk information (scrolling versus no scrolling), Study 2 will look at whether special features (e.g., testimonial videos, interactive videos) influence the perception of risks and benefits, and Study 3 will investigate whether links to and citations from external organizations referenced on the home page affect consumer perception and understanding of risks and benefits.
“It was anticipated that the FDA’s draft Internet guidance … would address the key question about the possible use of hyperlinks to provide risk information in a variety of online and social media formats,” according to Arnold I. Friede, Arnold I Friede & Associates. “In its 14 [notices of violation] on the use of hyperlinks in sponsored research results, FDA categorically rejected the possibility that providing information via such links could possibly constitute ‘fair balance.’”
Friede also commented that the FDA’s “categorical rejection” of the use of hyperlinks to provide risk information is “inconsistent with the approach FDA has taken in other analogous contexts.”
Without any guidance in “the near term,” Friede continued, industry has two choices: (1) “refrain from engaging in any behavior that is the subject of the proposed studies,” or (2) “make rational decisions about what is and is not justified, or at least what should be justified, from a legal, policy, and communications standpoint.”
If a company takes the latter approach, it should be “prepared to defend those decisions if questioned by the FDA,” Friede asserted, adding that “many decisions in business are made in the absence of perfect knowledge.”
The Coalition’s Kamp consistently has stated that agencies and clients should continue their marketing efforts online while following existing FDA policy, especially in light of DDMAC officials’ statements that the FDA will not break new ground with its social media guidance.
“Wrong or right, the FDA has been up front in stating that it has no intention of creating a new Internet and social media policy at this time,” Kamp said. “FDA’s plan to conduct research in this area is just one more indication of that position.”
April 29, 2011 – In a Webinar yesterday, the U.S. Food and Drug Administration’s (FDA’s) Division of Drug Marketing, Advertising, and Communications (DDMAC) reminded medical marketers of its continued actions to enhance surveillance and monitoring of industry marketing by urging physicians and other healthcare professionals to report any potentially misleading marketing activities to DDMAC.
Although the year-old program has resulted in only two Warning Letters to date, the DDMAC clearly wants the industry, doctors and the public to know it intends to aggressively enforce its rules. “I have my doubts about the value of this program,” said John Kamp, executive director of the Coalition for Healthcare Communication, “but FDA is sending a clear signal. We must pay attention.”
Catherine Gray, DDMAC management advisor, explained in the FDA-sponsored Webinar that although DDMAC is charged with regulating print, broadcast and oral communications made by or on behalf of prescription drug companies, it cannot “possibly be in every discussion with every sales rep,” so it is asking healthcare providers to use the agency’s “Bad Ad” initiative to report any marketing activities that could potentially be in violation of FDA marketing rules.
During the Webinar, Gray explained that the Bad Ad outreach program is designed to educate healthcare providers about the role they can play in helping the FDA enforce rules requiring prescription drug advertising and promotion to be truthful and not misleading.
The program “fills gaps” between what DDMAC finds during its normal surveillance activities and allows the agency to gain important intelligence regarding company-driven interaction with healthcare professionals, “including oral statements made in physician offices or at industry-sponsored lunches or dinners,” she said. “The program was created by two former drug reps who are very familiar with what goes on behind closed doors.”
Gray outlined the most common types of drug promotion activities that could be considered misleading:
- Omitting or downplaying the product’s risk factors;
- Overstating effectiveness of the product;
- Making misleading drug comparisons without substantial evidence; and
- Promoting unapproved use(s) of a drug.
She noted that this last violation type represents an area “where individuals can be very helpful” because physicians may be more likely to be apprised of unapproved uses in private settings. She indicated that healthcare professionals who become aware of any of these potential violations should submit – through the Bad Ad program e-mail address (BadAd@fda.gov) – their name (or the complaint can be anonymous), the name of the drug in question, when the activity occurred and what it was, “as well as the drug rep’s name” if one was involved. Gray remarked that competitors also may use this forum to file complaints.
Then, DDMAC will evaluate the allegation and determine whether action – such as an Untitled Letter or a Warning Letter, a criminal investigation, seizure, injunction or consent decree – is warranted. “Even if the agency does not take action after you submit a complaint, the data collected through the program is valuable information for ongoing DDMAC surveillance,” Gray told Webinar attendees. Further, she described several DDMAC enforcement actions that were a direct result of complaints received through the Bad Ad program.
Gray concluded by telling attendees that when physicians tell DDMAC about specific incidents, “we can take steps to stop it.” Healthcare professionals can have a big impact … in stopping misleading promotion,” she said.
Announcement Sends Ominous Signal to Industry Stakeholders
March 18, 2011 — The Centers for Medicare & Medicaid Services (CMS) has given the industry its first glimpse of how it will implement the national registry of payments to doctors by sending a notice of a stakeholders’ call for next week, and the glimpse is not encouraging. Sounding like CMS wants more regulation, not less, the notice starts out by asking what “additional” payments beyond those specified in the statute should be considered.
The HHS/CMS conference call on the implementation and potential expansion of the Physician Payment Sunshine Provision of the Affordable Care Act, is entitled “Open Door Forum on Transparency Reports and Reporting of Physician Ownership or Investment Interests.” CMS says it is: “seeking stakeholder input on a number of topics defined in the statute.” Those include:
- Comments on additional forms and natures of payment and transfer of value to be considered by HHS.
- Accessibility to and usability of the reported data by consumers.
- Mechanisms for accurate, efficient, and cost-effective reporting of data.
Details for the call:
Date: Thursday, March 24, 2011
Time: 2:00PM – 4:00PM EST
Conference ID: 51513526
** Capacity is limited so dial in early. You may begin dialing into this forum as early as 1:45PM EST.
Submit additional thoughts or feedback following the session to an email address established for this purpose: firstname.lastname@example.org.
Commentary on why this issue matters to stakeholders — from Peter Pitts of Porter Novelli – provided below:
Be there or be square – as in squarely in the crosshairs of the COI Polloi. (COI = Conflict of Interest).
According to the HHS/CMS announcement, “The Physician Payment Sunshine Act has the potential to bring about a systemic shift in the health care industry, with government taking a larger role in care of patients.”
Just what everyone (and by “everyone,” I mean “the American public”) fears – “government taking a larger role in care of patients.”
If you go back and look at all the rhetoric surrounding this particular piece of legislation, you will not find a call for “government taking a larger role in the care of patients.”
But, per the good folks in the Humphrey Building, this law certainly does have the potential for significant and severe mission creep. And that’s where it’ll be headed unless we all start paying attention.
And the first person to be queried on this is Senator “Sunshine Charles” Grassley. Is this what he intended? Here’s what he said: ““Shedding light on industry payments to physicians would be good for the system. Transparency fosters accountability, and the public has a right to know about financial relationships.”
Nothing there about “government taking a larger role in the care of patients.”
Further, since this conference call is being advertised as an “open door,” perhaps it’s time to open the door to a discussion about the incentives physicians get from insurance companies to switch patients from brand name to generic medicines, or from trial lawyers to be expert witnesses?
If physicians and academicians are paid by industry for their medical expertise – and those payments are important to disclose – why aren’t payments for that same expertise important to disclose when they’re being used by insurance companies and lawyers?
When is a conflict not a conflict? The answer, it seems – is when it’s convenient to the Brotherhood of the Conflict of Interest Priesthood, the COI Polloi.
Who’s pure and who isn’t? Here’s the answer – nobody is 100% pure. Not even Ivory Soap is 100% pure – and it floats!
In the Feb. 7, 2009, edition of The Lancet, Richard Horton points out that the battle lines being drawn between clinician, medical research and the pharmaceutical industry are artificial at best — and dangerous at worst. Dangerous, because all three constituencies are working towards the same goal — improved patient outcomes.
His main point is that we must dismantle the battlements and embrace of philosophy of “symbiosis not schism.” It’s what’s in the best interest of the patient.
The thought of expanding the Sunshine Act to facilitate “government taking a larger role in the care of patients” is an unsunny proposition indeed.
Not to mention an inappropriate one.
March 11, 2011 — As the public debate over digital privacy continues, federal regulators on and off Capitol Hill are telling online marketers that now is the time to widely adopt strict self regulatory programs that enable Web users to opt-out of unwanted tracking and marketing. If not, marketers can expect legislation and/or regulation by the Federal Trade Commission (FTC) creating a federal mandate and a possible Do Not Track system like the FTC’s popular Do Not Call program.
New threats and regulatory proposals seem to be popping up everywhere, from proposals by the Federal Trade Commission and Department of Commerce, to hearings and proposed legislation in the Senate and the House. Meanwhile, the Coalition for Healthcare Communication, the 4A’s and other leading marketing companies are reminding policy makers of the industry’s opt-out program while urging more advertisers and agencies to participate.
“We believe that the industry has taken a strong leadership role in educating and protecting consumers in the online advertising arena,” said Dick O’Brien, head of the 4A’s Washington office. “The industry’s new self-regulatory program is up and running and providing consumers with effective and workable options to help them manage online advertisements.”
The members of the Digital Advertising Alliance include the 4A’s, the Association of National Advertisers, the American Advertising Federation, the Direct Marketing Association, and the Interactive Advertising Bureau. The Alliance program, developed in conjunction with the Better Business Bureau, has been operating since late 2010.
But the warnings keep on coming. For example, on March 8, at the 4A’s annual meeting in Austin, Texas, David C. Vladeck, director, FTC Bureau of Consumer Protection, told attendees that although the FTC “recognizes that behavioral advertising benefits consumers,” it also “raises serious privacy concerns.” Vladeck explained that the preliminary report issued by the Commission in December 2010, “Protecting Consumer Privacy in and Era of Rapid Change: A Proposed Framework for Businesses and Policymakers,” was intended to “spur industry to develop more robust and effective best practices and self-regulatory guidelines.”
FTC Calls for More Progress with Self-regulation
Vladeck said the FTC supports the industry guidelines and an opt-out mechanism. But while he finds them “encouraging,” he’s concerned that they are not yet widely adopted and apparent to users on the Internet.
“We’re concerned about [other] practices that subvert or undermine consumer choice, and our enforcement agenda reflects that concern,” Vladeck said. In his view, a successful Do Not Track mechanism should include five basic components, as follows:
- Be easy for consumers to use and understand;
- Be effective and enforceable;
- Be universal – consumers should be able to go to one place to exercise their preferences across the board;
- Allow consumers to opt out not only from the use of tracked data, but also from its collection; and
- Ensure that consumers’ choices will be persistent – they should not have to reset their preferences every time they clear their cookies or close their browser.
“We think the industry is up to the task of ensuring that both the design and implementation of the mechanisms it is developing will have those components and operate effectively,” Vladeck said, adding that any Do Not Track mechanism “should build upon existing industry innovations.”
Speaking on a 4A’s meeting panel to discuss the new program, Carla Michelotti, executive vice president and chief legal, government and corporate affairs officer for Publicis Groupe’s Leo Burnett, indicated that current self-regulation programs are not yet fully supported by many advertising agencies. “The self-regulation program is a very good program, but you need to read, understand and know where an agency fits in,” she said. Accordingly, the 4As and the Coalition will soon announce training programs for agency executives to increase awareness and participation.
Panelist Eric Mower, CEO of Eric Mower & Associates, emphasized the connection between privacy and stewardship, especially for agencies. “Any organization dealing with consumer data has a responsibility,” he said. “Voluntary self-regulation is just that – you do it because you feel responsible.”
Lack of Progress May Open Door to Legislation
Although successful self-regulation programs may need some tweaking, Vladeck does not believe that legislation is necessary to accomplish the FTC’s goals of protecting online consumers. However, his statement that the Commission has been “disappointed in the progress of self-regulation,” leaves the door open for legislative proposals. Two pieces of Do Not Track legislation already have been introduced in the House of Representatives; two more may be forthcoming.
The Do Not Track Me Online Act of 2011 (H.R. 654), was introduced Feb. 11 by U.S. Rep. Jackie Speier (D-Calif.) and would direct the FTC to develop standards for a Do Not Track mechanism that also would allow individuals to opt out of the collection, use or sale of their online activities. On Feb. 10, U.S. Rep. Bobby L. Rush (D-Ill.) introduced H.R. 611, the Best Practices Act, which would establish ground rules and privacy minimums for consumers, including “opt-in” consent to disclose information to a third party. Under Rush’s bill, companies that collect personal information would be required to disclose their practices and provide concise, meaningful and easy-to-understand notices of these practices.
U.S. Rep. Ed Markey (D-Mass.) also plans to introduce legislation that he indicates will include a Do Not Track provision so that children do not have either their online behavior tracked or their personal information collected or profiled. Additionally, U.S. Rep. Cliff Stearns (R-Fla.) is expected to introduce a privacy bill that will include a provision for an FTC-approved five-year self-regulatory program and would prescribe requirements for a self-regulatory consumer dispute resolution process.
On the other side of Capitol Hill, the Senate Commerce Committee will be holding a hearing March 16 to examine online consumer privacy – specifically commercial practices that involve “collecting, maintaining, using, and disseminating large amounts of consumer information, some of it potentially very sensitive and private in nature.” This hearing is the second in a series of hearings examining how users’ information is stored, collected and used. [Editor’s note: Senate hearings normally are streamed live on the Committee Web site. To access, go to: http://commerce.senate.gov/public/index.cfm?p=Hearings]
“Modern technology has connected people with the world and led to new innovations, new products and new experiences,” Commerce Committee Chairman John D. (Jay) Rockefeller IV (D-W.Va.) said. “But with these new opportunities come new risks. I want to know if the privacy protections we have in place are enough, or whether Congress needs to step in and do more.”
For further information, contact John Kamp at email@example.com. Add your comments on this important issue below.
Although 2011 brings political party shifts in Congress and new challenges, the mission of the Coalition for Healthcare Communication (CHC) remains the same: To protect, for society and individual patients, the benefit of the free flow of healthcare information. This year the CHC will be focusing on four major issues: (1) tax treatment of marketing costs; (2) “transparency,” conflict of interest and collaboration; (3) proposals to limit the collection and use of Rx and consumer medical data; and (4) FDA DDMAC’s policies and guidelines (including social media guidelines). The 2011 Focus of the Coalition describes the issues CHC will be tracking in 2011, the political climate in which those issues will be debated and how potential outcomes could change the Rx communication business and affect the public health.
2011 Medical Marketing Predictions published in
Medical Marketing & Media, December 30, 2010 — by Matthew Arnold
Will 2011 be the year FDA loosens up and opens the floodgates on a flurry of big new approvals? More seriously, will they get around to issuing social media guidance for pharma before Baby New Year morphs into Father Time again? We have no idea, but we did ask some of the smartest folks we know in medical marketing about their predictions for the industry in 2011.
Here’s what they told us: http://bit.ly/fV5Prv
Start the New Year right. Add your predictions to those of John Kamp, Nick Colucci, and other industry leaders.
John Kamp, executive director, Coalition for Healthcare Communication
- Congress will raise the medical marketing tax issue as it searches everywhere to find revenue. Indeed, a high profile member of Congress will propose the elimination of the deductibility of all marketing costs for all industries. The deficit will simply be too big to ignore, and virtually every good and bad tax idea will be discussed.
- The Federal Trade Commission chairman and Senate Commerce Committee chairman will support strong new digital tracking limits, especially on “sensitive issues” including medical information. New Republican leaders of the House Commerce Committee will be less enthused.
- The FDA will publish the first of several documents addressing internet and social media. Although useful, medicine and device companies will continue to be very careful, especially with social media. Independent internet publishers will continue to innovate and create sites that are industry friendly and companies will expand their visibility by advertising on those sites. Progress will remain slower than for consumer goods, but growth on our industry also is inevitable.
- Industry and government payers as well as provider groups will continue to look to medicine and device manufacturers to help them manage their financial risks in insuring and treating patients. Medical manufacturers and their agencies increasingly will be developing programs for payers and providers that foster compliance with best practices and standards of care. Everyone involved will be looking to improve efficiencies by improving patient care. Every industry sector and patients will benefit.
- The FDA and HHS will continue to push for “parallel reviews” of device and drug approvals by FDA and reimbursement decisions by HHS. Everyone involved will be tentative and skittish.
- PDUFA 2012, FDA REMS and HHS Comparative Effectiveness will be on the top of everyone’s list of worries and opportunities.
- Electronic medical records will inch toward reality, creating optimism and consternation everywhere.
Arnie Friede, principal, Arnold I. Friede & Associates
We can expect more, and even more aggressive, enforcement from FDA in general and DDMAC in particular in 2011. I think that the impending social media guidance will be largely unhelpful and will raise more questions than it answers, if it even emerges at all. This is a year when pharma and the agencies that work with the industry ought to be reminded about the need for proactive engagement in FDA legal and regulatory matters. It makes no sense to wait until the defecation hits the ventilation, i.e. to wait until you get a Warning Letter or NOV from DDMAC. It may be too late to fix the problem given all the liabilities that go along with being a recipient of such correspondence. On the contrary, I encourage everyone to anticipate and address problems up front. That is the only way to manage risk reasonably in the current hostile enforcement environment.
Debrianna Obara, VP, media, Razorfish Health
In the digital world of health, more and more brands will focus on distribution of content as opposed to straight display media or search buys. This shift will allow brands who have invested in educational and branded content to amortize that investment by getting more health seekers to interact with that content. The user benefits, as they can interact with valuable information without leaving their trusted 3rd party website of choice (such as AOL/Yahoo!/WebMD).
Dana Maiman, CEO, Draftfcb and CEO/president, Draftfcb Healthcare
More and more clients will be looking for wholly integrated, multi-channel solutions within one agency offering, realizing that bundled services are far more efficient and effective for their brands.
Nick Colucci, president and CEO, Publicis Health Care Group
REMS revolution: REMS will shape the way companies spend their marketing dollars. REMS not only maximize brand value, but help meet the drug development needs of the future.
Acquisitions abound: 18 of the biggest drugs in the world will lose patent protection in the next five years. As revenue from blockbuster brands and mature markets decline, companies can use their balance sheets to “buy” promising portfolios and local companies in emerging markets.
Personalized medicine momentum: personalized medicine has always represented a bet on the future; however, forces now converging suggest its benefits are within reach for patients, payers and providers. We are beginning to see the possibilities, using data to improve personal care. Product marketers need to be prepared to narrow their focus and develop more capabilities in analytics and market access.
Regulatory rigor: new officials promise stiffer marketing enforcement. Warning letters are an immediate reaction and can be sent with a push of a button. Marketers need to be hyper-vigilant and turn around responses and justifications with haste and content to avoid triggering more aggressive Beltway engagement.
Sample reporting: beginning April 2012, pharma companies will be required to report sample-distribution activity. While tracking is not new, we will see turn-key solutions to manage sample compliance proactively. Programs that provide (and verify) access to clinical starters without personal rep visits will be used more frequently to support broad geographical needs.
Alternative reps: physician face-time availability and sales-force resources are diminishing. Still, a need for information demands innovative techniques. Most major pharma companies are now working with outsource providers to achieve their outreach needs. Meanwhile, others are turning to digital sales tools, including e-details, online seminars and virtual-training sessions.
Focus on payers: insurance companies in particular will want to see comprehensive value propositions backing up all claims of clinical efficacy and cost effectiveness with rigorous data and peer-reviewed articles. This means we will have to start considering payer needs as early as Phase II.
Michael Golub, MD, chief medical officer, Digitas Health
It won’t take long for large healthcare systems to gain the ability to mine data from their electronic health records to determine the outcomes related to–and cost-effectiveness of — pharmaceutical products. Look for one or more major pharmaceutical companies to begin exploratory talks with the FDA regarding the criteria that would allow data licensed from large healthcare organizations to be utilized within the marketing arena.
As use of the iPad within healthcare continues to expand, look for disease state education to quickly migrate to iPad-friendly (and similar-device compatible) platforms. These devices offer the benefits of mobile versatility and instant digital channel connectivity (in space and time) with a screen size suitable for integration into the doctor-patient dialogue.
Alfred O’Neill, group VP, client engagement & strategy, Razorfish Health
We’ll see more pharmas following the consumer and letting one person personify the brand in social media, with a better understanding of how to use social media to personify the brand and drive cost-effective patient eCRM. Using the mentor of the Facebook page as “host” and voice of the eCRM adds credibility and humanity where currently most biopharma eCRM is one-size-fits-all.
We may move to a model where a patient advocate is assigned a Facebook or community site attached to it that allows for a different form of engagement with content. The content is RC approved, but the “patient owner” is the face of the Facebook community, and could be the one to encourage signing up for eCRM and other apps to keep the sharing going. Sharing in this sense can be controlled and open fields, adverse events and other hurdles are addressed.