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By John Kamp
Executive Director, Coalition for Healthcare Communication
Aug. 6, 2012 — When Congress recessed last Thursday we marked nearly the end of this session and began the final stretch of the Congressional and Presidential elections that will affect the next four years of governing. From this point forward we have the all-important
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nominating conventions, only eight more legislative days in September, the elections, and a very important lame-duck session. 2013 will bring us new faces in Congress and perhaps the White House. Here are some of the highlights of what transpired at the end of the session, as well as a look at what might happen next.
PDUFA V: The Five-year FDA Funding & Fees Bill Passes
Congress succeeded in funding the FDA for the next five years with comparatively little drama, fireworks and even political posturing. Sometimes the government works. Most importantly, the legislation did not include any amendments to ban or further restrict marketing and did include one mildly optimistic provision prompting the FDA to complete its social media policies within the next two years. (Presumably, nearly five years from the 2010 hearings will be enough time to complete findings, deliberations and orders. But, you will get no guarantees here.)
Otherwise, the Prescription Drug User Fee Act V (PDUFA V) sets new approval guideposts for pharma applications, extends fee programs to generics and medical devices, and reasonably funds the FDA for the next five years (unless the across-the-board cuts from last year’s failed budget agreement go into effect as scheduled on Jan. 2, 2013). (See note on the Lame Duck session below.)
Health Reform After Supreme Court Decision
The U.S. Supreme Court left most provisions of the Affordable Care Act (ACA) in place. Of particular importance to us, the following provisions remain intact: the Sunshine Act, the FDA mandate to report to Congress on the advisability of creating a “drug facts box,” and the essentials of the PhRMA deal that promised $80-100 billion dollars from pharma in return for closing the Part D “donut hole” and adding up to 38 million newly insured patients to the medicine customer pool.
Although politicians and policy wonks are speculating wildly on how many states may “take advantage” of the freedom to turn back federal money to insure many of those new patients, it seems at least plausible that few states will refuse federal dollars. Understand that under the ACA, federal tax dollars contribute 100 percent of the costs for
the newly insured for the first three years, and then contribute 90 percent of costs in the subsequent years. Meanwhile, expect that 2013 – no matter who wins the elections – will be marked by more tweaks to healthcare reform, presenting more opportunities to upset the PhRMA deal, and to invoke more criticism of pharma prices and our marketing programs.
Lame Ducks, the Fiscal Cliff and Tax Expenditures
While incumbent candidates seem happy to keep the political choices of the post-elections “lame duck” session in the background, Wall Street, Washington wonks, economists and many
others are anxiously awaiting the hard money decisions that must be made to avoid the fiscal cliff created by the Super Committee budget ceiling bust earlier this year. In short, that debt ceiling bill – unless revised – sets in place a series of budget cuts and tax increases economists promise would put the United States firmly back into a recession.
Everyone “Inside the Beltway” seems to understand the stakes, but few are willing to predict how the Congress will respond. Last Thursday, former House Member Vic Fazio (D-Calif.), a longtime friend of the advertising industry, made this observation: “Everyone’s ox will be gored or the compromise will not be good for anyone.” Fazio said he hopes that Congress and the President-elect will rally around the proposals of last year’s Simpson-Bowles Committee (http://www.fiscalcommission.gov/).
These proposals include tax increases and budget cuts virtually no candidate wants to talk about on the campaign trail – tax increases for nearly everyone and spending cuts in defense and virtually every popular program from Social Security to Medicare. Meanwhile, The Advertising Coalition, including the AAAA and the CHC, assumes that every tax expenditure – including the deduction for marketing costs – could be considered in that session and is fully prepared for battle.
Despite some recent luck predicting the outcome of the Supreme Court decision on the ACA, the November elections are just too close to call. Moderates in the battleground states of Florida, Ohio and Virginia, and even in Iowa, Minnesota, Missouri, Pennsylvania, Wisconsin and other often-settled states, will decide the election. Recent polls in many of those states give Obama the edge with moderate voters right now by 4 to 8 percentage points, but similar polls of committed voters (those virtually certain to vote) give Romney a four-point edge.
Regardless, both candidates and their Congressional counterparts have much riding on the political conventions – when many uncommitted voters pay attention and often decide – and both desperately watch the economies of the United States and the European Union, employment numbers, gas prices and every other indicator of consumer/voter sentiment as the election nears. Many say the election will again come down to who is most likable and that Romney, especially, is in need of a Madison Ave. makeover.
So, I will leave it to you and the undecided voters to tell me who will win the Presidential election. Meanwhile, the Congressional prognosticators say that the Republicans likely will retain the House, perhaps losing a few seats, and that the Senate, too, is way too close to call. Many suggest that in the Senate the final seat number will be somewhere between the 52-48 goalposts, and that even a 50-50 split is possible, giving the Vice President a very important deciding vote.
In summary, while the stakes are high for us and the entire country, the political and health policy events will move very quickly over the next several months. Contributing members of the CHC will get a much closer view of these evolving events by participating in the DC meeting on Sept. 18 and 19. Dinner on the 18th will be highlighted by a nonpartisan late look at the elections from a leader from Cook Report. The next morning will start with two diverse views on the government’s role in the future of U.S. healthcare, followed by an interactive session among CHC leaders regarding what our industry must do to survive and thrive amid the imminent changes while doing its part to improve the care of patients and the public health.
July 10, 2112–FDA yesterday announced many details of its long awaited guidance to sponsors of pain drugs under the mandatory REMS requirement. While these drugs improve the quality of life for many patients suffering from serious pain, they are also addictive and subject to misuse and abuse by others.
Read the following blog entry published today by Policy and Medicine for more details, and stay tuned for more information on how both promotional education and certified CME will play a major role in this education.
John Kamp, Executive Director, Coalition for Healthcare Communication
|FDA Releases Final Risk Evaluation and Mitigation Strategies (REMS) for Extended Release/Long Acting Opioids Including a Prescriber Education Program
Posted: 09 Jul 2012 07:47 PM PDT
After three years of work the Food and Drug Administration (FDA) released its final Risk Evaluation and Mitigation Strategies (REMS) for extend-release (ER) and long-acting (LA) opioid medications. This is the first time that the FDA has mandated a class wide REMS and much of what is recommended will be looked at closely for future class REMS.
ER/LA opioids are highly potent drugs that are approved to treat moderate to severe persistent pain for serious and chronic conditions (list of ER/LA opioid products). The misuse and abuse of these drugs have resulted in a serious public health crisis of addiction, overdose, and death.
After input from many stakeholders dating back to November 2011, the Food and Drug Administration (FDA) also released the “Blueprint for Prescriber Continuing Education Program” regarding the use of opioids. The Blueprint contains core messages intended for use by continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extended release opioids under the required risk evaluation and mitigation strategy (REMS) for these products (Opioid REMS).
A REMS is a risk management plan that goes beyond requirements in the drug prescribing information to manage serious risks associated with a drug. The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require companies to develop and implement a REMS when necessary to ensure that the benefits of a drug or biological product outweigh its risks.
The CME Coalition offered its strong support for FDA’s efforts. Andrew Rosenberg, Senior Advisor to the CME Coalition stated, “When there is a public health imperative, such as the abuse of long acting opioids, continuing education of providers is integral to improving patient outcomes and advancing the health of the country.” Rosenberg continued, “We are pleased that the FDA views CME as a change agent and valuable resource to improve caregiver behavior in this vital area.”
FDA’s final REMS is important because it marks a crucial step in federal health care agencies for recognizing the importance of CE and continuing medical education (CME). The Agency’s logical and reasoned approach towards working with industry and accredited CE providers is a significant step in the right direction not only for patients and physicians but for the future of our healthcare system. The opioid REMS represents the cross-collaboration of CE providers, industry, consumers, patients, and FDA. Moving forward, FDA and these stakeholders should look at other opportunities to collaborate and use CE/CME to improve patient outcomes, reduce healthcare costs, and lower safety risks.
Opioids are widely prescribed and carry a risk of abuse, misuse and death. In 2009, there were nearly 425,000 emergency department visits involving non-medical use of opioid analgesics. According to estimates from the Centers for Disease Control and Prevention, 14,800 Americans died from overdoses involving opioid pain relievers in 2008. In 2009, there were 15,597 deaths involving an opioid medication.
The REMS is part of a federal initiative to address the prescription drug abuse, misuse, and overdose epidemic. The REMS introduces new safety measures designed to reduce risks and improve the safe use of ER/LA opioids, while ensuring access to needed medications for patients in pain. FDA is requiring a REMS for ER/LA opioid analgesics because FDA has concluded that there is a disproportionate safety problem associated with these products that must be addressed.
“Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”
All ER/LA opioid analgesics will be required to have a REMS. The new ER/LA opioid REMS will affect more than 20 companies that manufacture these opioid analgesics. Under the new REMS, companies will be required to make education programs available to prescribers based on an FDA Blueprint. It is expected that companies will meet this obligation by providing educational grants to accredited continuing education (CE) providers to offer training to prescribers at no or nominal cost. These CE activities must cover the content and messages of a blueprint developed by FDA for this purpose.
The REMS also will require companies to make available FDA-approved patient education materials on the safe use of these drugs. The companies will be required to perform periodic assessments of the implementation of the REMS and the success of the program in meeting its goals. The FDA will review these assessments and may require additional elements to achieve the goals of the program.
“We commend the FDA for taking action to save lives by increasing access to prescriber education,” said Gil Kerlikowske, director of the Office of National Drug Control Policy. “Since day one, the Obama Administration has been laser focused on addressing the prescription drug abuse epidemic and today’s action is an important contribution to this comprehensive effort.” The new ER/LA opioid analgesics REMS is also part of the national prescription drug abuse plan announced by the Obama Administration in 2011 to combat prescription drug misuse and abuse.
ER/LA opioid analgesics are widely prescribed medicines with an estimated 22.9 million prescriptions dispensed in 2011, according to IMS Health, which provides services and information to the health care and pharmaceutical industries. It is estimated that more than 320,000 prescribers registered with the Drug Enforcement Administration (DEA) wrote at least one prescription for these drugs in 2011.
ER/LA opioid analgesics are associated with serious risks of overuse, abuse, misuse and death and the numbers continue to rise. According to the Centers for Disease Control and Prevention, 14,800 Americans died from overdoses involving opioids in 2008. In 2009, there were 15,597 deaths involving these medications – nearly four times as many deaths compared to 1999.
“There are a limited number of options available for the treatment of pain. Opioids are one option, but they carry a significant risk of misuse, abuse, overdose and death,” says Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction Products. “We’re trying to help physicians manage the risks and improve the safety of using these medicines.”
“Misuse and abuse of prescription opioids is a complex problem and demands a holistic response,” said John Jenkins, M.D., director of CDER’s Office of New Drugs. “The new REMS program is one component of a multi-agency, national strategy to address this important public health issue.”
Role of CME
The central component of the ER/LA opioid analgesics REMS is an education program for prescribers (e.g., physicians, nurse practitioners, physician assistants). There are approximately 320,000 prescribers of ER/LA opioid analgesics in the United States, and FDA expects companies to train 25% of these prescribers at the end of the first year following implementation of the program, 50% after two years, and 60% of them within three years of the start of training.
It is expected that the first continuing education activities under the REMS will be offered to prescribers by March 1, 2013. The FDA expects the training to take approximately 3 hours, but the CE providers will determine the number of CE credit hours that will be offered for the courses based on established standards for such determinations. Key components of the ER/LA opioid analgesics REMS include:
- Training for prescribers. Based on an FDA Blueprint, developed with input from stakeholders, educational programs for prescribers of ER/LA opioids will include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs. In addition, the education will include information on how to recognize evidence of, and the potential for, opioid misuse, abuse, and addiction, and general and specific drug information for ER/LA opioid analgesics.
- Updated Medication Guide and patient counseling document. These materials contain consumer-friendly information on the safe use, storage and disposal of ER/ LA opioid analgesics. Included are instructions to consult one’s physician or other prescribing health care professional before changing doses; signs of potential overdose and emergency contact instructions; and specific advice on safe storage to prevent accidental exposure to family members and household visitors.
- Assessment/auditing. Companies will be expected to achieve certain FDA-established goals for the percentage of prescribers of ER/ LA opioids who complete the training, as well as assess prescribers’ understanding of important risk information over time. The assessments also cover whether the REMS is adversely affecting patient access to necessary pain medications, which manufacturers must report to FDA as part of periodic required assessments.
It is expected that the first continuing education activities under the REMS will be offered to prescribers by March 1, 2013.
Follow-up surveys will be conducted to assess prescriber understanding of the important safety information and assess whether the REMS is adversely affecting patient access to necessary pain medications. Companies plan to offer additional funding to CE providers as an incentive to identify and track prescribers who take the REMS-compliant training and to perform follow-up surveys to assess the amount of information retained.
As part of the REMS, companies will report periodically on actions taken to implement the REMS, including, for training provided by CE providers, the number of grants awarded to CE providers, the number of prescribers trained, and other relevant information. If FDA determines that the REMS is not meeting its goals, the Agency will re-evaluate the program.
There is no mandatory requirement that prescribers take the training and no precondition to prescribing ER/LA opioids to patients. However, the Obama Administration endorsed a mandatory training program on responsible opioid prescribing practices in April 2011 as part of its comprehensive plan to address the epidemic of prescription drug abuse. The program, which would be linked to DEA registration by providers, would require legislative changes that are being pursued by the Administration.
The FDA continues to support this approach, but absent the needed legislation, intends to exercise its authority to require mandatory elements for companies and voluntary elements for prescribers – all of which are important and necessary steps to help curb the misuse and abuse of ER/ LA opioid analgesics, without being overly burdensome.
For patients, the benefit is two-fold. First, Hertz notes that health care professionals who participate in the REMS
program will have more knowledge and awareness and can have frank conversations with their patients about the risks and appropriate use of opioids. A new patient counseling document will be available for prescribers to use when talking to their patients about these medications.
The REMS also includes an updated Medication Guide—a paper handout for patients that the pharmacist will provide when a patient receives an ER/LA opioid medication. This document, Hertz says, is written in plain language to simply explain how to safely use ER/LA opioid medicines.
The American Academy of Pain Medicine, which represents 2,600 pain physicians and treatment teams, issued a statement supporting FDA’s issuance of the REMS for opioids, calling it a “huge leap forward.”
“Through proper education and training, opioids can be administered safely to patients and continue to be an important option in the treatment of chronic and debilitating pain that is suffered by millions of Americans.” AAPM will also shortly be issuing a series of best practices for both patients and prescribers that can further reduce adverse outcomes associated with opioids.
Purdue Pharma L.P., maker of several opioids including OxyContin®, also announced its support for FDA’s REMS for opioids.
Sept. 8, 2011 – As ProPublica and its media partners roll out their reports today on industry payments to physicians, doctor and industry groups are urging reporters to include significant contextual information on the nature of these relationships, and note that they provide significant value to both professionals and patients.
Reporters are urged to contact representatives from the Coalition for Healthcare Communication (CHC), the Association for Clinical Researchers and Educators (ACRE), and the Pharmaceutical Research and Manufacturers of America (PhRMA)
Below is a link to the Association of Clinical Researchers and Educators (ACRE) press release. There are several ACRE physicians listed in the press release who are interested in speaking with the media .
Here is a copy of PhRMA’s press release with links to additional resources.
Reporters can contact John Kamp this week in the NYC office (212-850-0708) and on his Blackberry (703-801-4582; email@example.com).
John Kamp, Executive Director Coalition for Healthcare Communication, 405 Lexington Ave, 18th Floor New York, New York 10174; Jkamp@cohealthcom.org ; NY: 212 850 0708; M: 703 801 4582; www.cohealthcom.org; Twitter: RxVoice
PhRMA Statement on Interactions with Healthcare Professionals
Washington, D.C. (September 6, 2011) — Pharmaceutical Research and Manufacturers of America (PhRMA) Executive Vice President and General Counsel Diane Bieri today issued the following statement on interactions with healthcare professionals:
“Interactions between biopharmaceutical research companies and healthcare professionals play a critical role in improving patient care and fostering appropriate use of medicines, and peer education programs – in which expert physicians meet with their fellow healthcare providers on behalf of biopharmaceutical research companies – represent one important element in these interactions.
[Check out the 'Company Interactions with Healthcare Professionals Contribute To Patient Care' page.]
“Through these programs, physician speakers are able to help their peers stay up-to-date with clinical data about new FDA-approved medicines, new uses of medicines, emerging risks and side effects, and more.
“This latest information is essential for physicians, who have to juggle the demands of clinical practice with the need to stay current. That’s why they value representatives of biopharmaceutical companies, who can provide important data during one of the few free moments of a physician’s busy day: lunch. Though a physician’s schedule is often full of back-to-back appointments with patients, they and their staff find this time to learn the information they need to provide the best care.
“It is true that some critics suggest that interactions between companies and physicians are inappropriate, but they disregard the important steps that companies take to ensure the quality of these informational relationships. Biopharmaceutical research companies comply with internal policies, FDA regulations, and the PhRMA Code on Interactions with Healthcare Professionals in order to ensure that their relationships with physicians are ethical and informative.
“We also support transparency in these relationships, including the Physician Payment Sunshine provisions of the Affordable Care Act. We understand that patients may want to know if their physicians take part in peer speaker programs and other activities, such as research, that are sponsored by biopharmaceutical research companies.
“Unfortunately, when taken out of context, publicly available information about physician interactions with biopharmaceutical companies does not convey the value of these relationships, which advance science and promote high-quality patient care.
“For example, according to a recent survey of physicians by KRC Research, nine out of 10 attendees of peer education programs said they found information they received at the programs to be up-to-date, useful and reliable. And more than half of attendees said they often gain knowledge or skills helpful to their practice.
“Ultimately, physicians make treatment decisions on a case-by-case basis, in the best interest of each patient. The information provided in peer speaker programs is just one tool that they can use in making those decisions. And in fact, according to KRC Research, physicians use a variety of factors in making prescribing decisions, including clinical practice guidelines; a patient’s financial status and insurance coverage, including formularies and prior authorization; information from biopharmaceutical companies; and of course, the patient’s particular situation, including drug interactions and side effects. This is evidenced by the high generic substitution rate in America, where nearly 80 percent of prescriptions are filled with a generic drug.
“As we move toward Sunshine Act implementation, we will continue to see increased transparency. We hope that the information provided is viewed within the context of value for the patient, and we hope that our ongoing experiences with transparency will help to encourage the Centers for Medicare and Medicaid Services to move forward in providing regulations on implementation of this important provision.”
By John Kamp, Executive Director, Coalition for Healthcare Communication
While the headlines cite implausible rates of non-compliance with FDA marketing regulations, a close reading of the recent PLOS One article, “Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing,” demonstrates:
1. the stated preference (bias) of the authors for their own brand of marketing regulation and
2. the underlying challenge industry, doctors and patients face under the current FDA regulation of drug ads.
Simply put, no one knows for sure what’s compliant until the FDA says so, most often in a FDA warning letter. This serves no one including doctors, patients, FDA and industry. Regardless of the authors regulatory preferences, they are absolutely correct in this conclusion: “The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.” Everyone loses under the current standards because the rules prevent good communication and subject the industry to unwarrented criticism from the press, politicians and medical professionals and uneven, unpredictable enforcement from FDA. Better regulations would enable better informed patients and doctors, thus better patient care.
The Coalition filed a Citizen Petition in March of 2006 asking the FDA to create clear, objective standards for professional and consumer advertising. It’s time for widespread industry dialogue on how to improve these rules to better serve the public health.
The PLOS article can be found on the PLOS website: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0023336
The Coalition Citizen Petition:
Peter Pitts, former supervisor for the Advisory Committee process at FDA, speaks plainly about the current Insanity over Conflict of Interest
By Peter Pitts
During my tenure at the FDA I was the senior official in charge of advisory committee oversight and the final decision-maker on who got a COI waiver and who did not. Many did not — but those who did received their waivers because FDA professional career staff made a strong case that these people weren’t just important to the advisory committee — but critical. And we should all pay attention to the nomenclature. It’s not about “conflict of interest” – it’s about (as Secretary Sebelius correctly says) “interest.” And having an “interest” is not necessarily a bad thing – as long as you’re transparent about it.
If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is a significant disservice.
In the February 7, 2010 edition of The Lancet, Richard Horton points out that the battle lines being drawn and 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.
Horton’s 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.
And so it is with this in mind that I share some promising news (as reported today in The Hill.)
GOP wants FDA bill to boost drug industry’s role
Republicans want to roll back new conflict-of-interest rules they say are depriving the Food and Drug Administration of needed expertise from the drug industry.
Democrats, meanwhile, will focus largely on the safety of imported drugs as Congress begins work on a five-year FDA reauthorization bill.
Congress tightened the FDA’s conflict-of-interest rules in 2007, as part of the last FDA reauthorization. But Republicans on the House Energy and Commerce Committee said they may try to loosen the standards in the next reauthorization, which needs to pass next year.
Committee Chairman Fred Upton (R-Mich.) said the upcoming bill should reverse “rigid, unrealistic conflict-of-interest provisions” that have delayed drug approvals. The rules govern who can participate in FDA advisory panels, which study safety and effectiveness issues.
“No longer can we afford to sideline experts simply because of their ties to the pharmaceutical industry,” Rep. Phil Gingrey (R-Ga.) said Thursday at an Energy and Commerce health subcommittee hearing.
Janet Woodcock, the director of FDA’s drug center, said the limits have slowed down the advisory committee process. The agency sometimes goes through the long haul of finding experts in a given field only to discover ties to the pharmaceutical industry toward the end of the process, she said.
The FDA has already begun negotiating with drugmakers and consumer advocates over the reauthorization bill. Thursday’s hearing marked the first formal involvement from Congress.
Technically, the purpose of the FDA bill is to reauthorize the programs through which drug and medical device companies pay the FDA to review their products for approval. But because it’s a must-pass measure — the people and offices that approve new products are paid for almost entirely by industry fees — it consistently becomes a magnet for broader policy changes.
Upton said Thursday that he also wants to reexamine a piece of the last reauthorization that gave the FDA more power to regulate drugs after they’ve been approved. The FDA can now require drugmakers to study certain safety issues and add new warnings to drug labels.
Upton and other committee Republicans say FDA overregulation is stifling innovation and preventing drug and device companies from creating new jobs. Rep. Henry Waxman (D-Calif.) argued that while getting new products to market is important, the FDA’s mission should be protecting public health rather than fostering job creation.
Energy and Commerce Democrats indicated that the safety of imported drugs will be their biggest policy focus. Rep. John Dingell (D-Mich.) began working on an import safety bill in 2007, the food-safety portion of which passed on its own in 2009.
The FDA inspects foreign factories far less often than domestic ones, and it can’t make a surprise visit outside of the United States. Those limitations received extra scrutiny following the 2007 heparin contamination, which Dingell cited repeatedly at Thursday’s hearing.
Jan. 31, 2011 – The Coalition for Healthcare Communication (CHC) today signed on with other leading marketing organizations to the Direct Marketing Association’s joint industry comments regarding the U.S. Department of Commerce’s Internet Policy Task Force’s green paper, entitled Commercial Data Privacy and Innovation in the Internet Economy: A Dynamic Policy Framework.
The joint comments call for continued federal support of voluntary codes of conduct to protect consumer privacy while ensuring that the Internet remains a platform for innovation. The commenters also ask the Commerce Department to acknowledge that online advertising and marketing provide significant benefits to the economy, consumers and businesses.
“The CHC supports the joint comments because they recognize that the Internet is such an important and valuable tool for consumers seeking medication information,” said John Kamp, CHC executive director. “The comments’ call for self-regulation dovetail with our organization’s goal of assuring the free exchange of scientific information without undue government interference,” he noted.
A proposal introduced by the Commerce Department’s Internet Policy Task Force enabling Internet users “to express a uniform and persistent choice to opt out of online behavioral advertising – a concept known as ‘Do Not Track’” – is the type of government interference that could hamstring the flow of valuable consumer information, the comments state.
According to the comments, the federal government should not, either through legislation or regulation, engage in the creation of a Do Not Track mechanism, “because such efforts risk threatening the Internet as it exists today, an area of American innovation and dominance, and a primary area of job growth and investment.”
The commenters contend that an About Ads Consumer Opt-out Page – a voluntary, self-regulatory program initiated in late 2010 – gives consumers data about the companies that have enabled customized ads on their browsers and allows them to opt out of some or all of the companies participating if they so choose.
“Although the CHC recognizes the right of citizens to protect their sensitive medical data, a government-imposed ‘Do Not Track’ list could cripple the ability of citizens to use the Internet for vital health information,” Kamp said. “Balancing legitimate privacy requests with the need for a robust Internet that offers healthcare professionals, patients and caregivers immediate access to useful data about medical conditions and treatments is not easy, but it is what all parties need to establish as the primary goal,” he remarked.
The CHC asserts that limiting or preventing access to free commercial speech is not the solution, according to Kamp. “Without free access to appropriate medical information, the lay public will not be able to assume greater responsibility for its own health, a critical factor in the nation’s effort to achieve efficient and effective usage of the healthcare system,” he said.
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.
January 5, by John Kamp — “The times are a changing” at FDA as Republicans take over the House and the Democrats maintain a fragile majority in the Senate. Such divisions bring much noise, especially in the two years before a Presidential election, but few bipartisan agreements in the form of legislation. The announcement by FDA Deputy Commissioner Joshua Sharfstein that he is accepting the job as head of health policy for the state of Maryland highlights much of the change . Not surprisingly, the resignation has insiders engaging in all sorts of speculation. Here’s my view of what matters. Add yours in a comment below.
January 6 Update — Today, Commissioner Margaret Hamburg announced that John Taylor will serve as Acting Deputy Commissioner in Sharfstein’s spot for 60 days. Meanwhile, Hamburg is looking to re-organize the Commission senior office staff . Taylor is exactly the sort of FDA vet needed as the FDA faces the new challenges from Capitol Hill and the elsewhere. Taylor has worked both inside and outside the FDA on these issues for nearly three decades and has exactly the sort of wisdom and expertise needed. Stay tuned as we follow and comment on these developments.
Meanwhile, check out some of the reports in the trade and general press. One of the better reports is in Pharmalot: http://t.co/j4N5yjj. Matt Arnold was one of the first out with this article at the following address quoting Peter Pitts and me: http://mmm-online.com
All in all, I think it was a good move for Sharfstein, a Harvard educated doctor with a career in public health. I’ve already said we’re likely to see him back on the federal payroll before the end of the Obama era, but the Maryland job just enhances his resume.
But, I worry that his departure leaves a huge hole in the staff of Commissioner Peggy Hamburg. Despite Sharfstein’s anti-industry reputation and stint as a staffer for Congressman Henry Waxman, Sharfstein brought intelligence and wisdom to the agency. Some of his best moments were in House and Senate hearings where he often calmly and ably responded to sharp questioning by Republican Members. But, then of course he was always protected from the worst by his old Democratic colleagues, including Congressman Waxman, then head of the House Commerce Committee.
The coming two years will be tougher for the FDA senior staff who appear in Congress. Several Members, including California Congressman Issa, Republican Head of a testy government oversight committee, will be out to make their mark against any Democratic appointee, especially from the widely followed FDA. By moving to Annapolis, Sharfstein avoids at least two years of nasty House oversight hearings. Dr. Hamburg doesn’t have the extensive Hill experience that guided Sharfstein, but she better get it soon. I was the FCC Congressional Affairs Director while the Congress was divided. Politics often trumped science and facts. Indeed, I have scars on my back and my soul from those days. During many hearings, it seemed like every Member shot first with hostile questions and then went out of the way not to listen to the answers. Things have only gotten nastier since.
Regardless of anyone’s politics, we all need the FDA to be and to be viewed as strong and smart. While, Dr. Hamburg must choose a deputy with great knowledge of public health and FDA, she also needs someone with Hill experience who will be respected by the thought leader Members in both parties. Three such candidates quickly come to mind. Kay Holcombe, now with Genzyme, commanded the respect of both parties while working on the Democratic staff of Committee Chairman Dingell and as FDA liaison for Commissioner Kessler. Similarly, Marc Scheinison, now with the Alston and Bird law firm, and Mary Pendergast, a consultant, represented FDA in several roles while maintaining a stance of substance over politics. We need these sorts of people to help FDA and citizens get the best in must pass legislation, including PDUFA 2012.
Patients, medical professionals and industry all have a stake. Think it over, then add your own ideas below.
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.