Dec. 14, 2011 — UPDATE — CMS has published the proposed rules enforcing the Sunshine provisions of the Affordable Care Act. See related materials on the site for details and instruction on how to comment on these proposals by the February 17, 2012 deadline.
Meanwhile review a recent column on the Sunshine Act appearing in Communiqué, Coalition for Healthcare Communication Executive Director John Kamp stated that “without adequate protection, complying with the Sunshine Act could damage our relationships with doctors and patients as well as endanger the improved patient care that results from collaboration.” He adds that “the days of avoiding sunshine and public scrutiny of industry-doctor relationships in the United States
To read the full column, go to: http://www.communiquelive.com/features/archive/2011/september/dont_get_burnt
Free registration may be required to access the piece.
Sept. 21, 2011 — The results of a study issued last week show that a majority of patients have a preference for new drugs over older drugs, and that the public does not completely understand the FDA new drug approval process. For marketers, this may be good news, but industry also may want to consider participating in efforts to better educate consumers about drug risks and benefits.
The study was conducted by researchers at the Dartmouth Institute for Health Policy and Clinical Practice and the VA Outcomes Group, and appeared in the Sept. 12 issue of the Archives of Internal Medicine. “The public may not realize that even with [FDA] approval, important uncertainties about the benefits and harms of these drugs remain,” the summary states.
Coalition Executive Director John Kamp noted that it is important for the public to be aware of both the risks and benefits that drugs provide. “Let’s not lose sight of the fact that while no drug is absolutely safe, both new and old drugs often help patients live better and longer lives, he said. “Education is key, including the education that comes with every consumer ad.”
During the survey, questions were posed to approximately 3,000 participants randomly selected from 30,000 households. In one scenario, participants received one of three explanations about a pair of heartburn drugs – one that was newly approved and one that was approved eight years ago. Controls received no explanation, the nondirective group was told that it takes time to establish safety for new drugs, and the directive group received explanations plus advice to “ask for [a drug] with a longer track record.”
Close to 40 percent of respondents in the heartburn drug scenario stated they believed that the FDA approves only “extremely effective” drugs, and 25 percent of respondents stated their belief that the FDA approves only drugs without serious side effects. “Brief explanations highlighting uncertainties about the benefit of drugs approved based on surrogate outcomes and the safety of new prescription drugs improved choices,” the survey results state.
The issue here is not the marketing of the new drugs, but better educating the public about the risks and benefits of any drug, explained Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest. “This survey doesn’t speak to industry’s explaining and marketing its own products. It is the FDA’s job to better define its approval process,” Pitts said.
Wayne Pines, consultant to the pharmaceuticals industry, said that the FDA has always had a challenge explaining its approval process and the risks that all products may have. “This study confirms that the public lacks understanding of what FDA approval constitutes,” Pines noted.
According to Pitts, “this is an opportunity for industry to better educate consumers about the benefits and risks of taking new drugs so they can have meaningful discussions with their doctors – who in theory have a better understanding of the FDA product development and
approval processes,” he told the Coalition for Healthcare Communication. “If asked, I would bet that industry would be willing to help better educate the public.”
Pines concurred that it is important for doctors and the pharmaceuticals industry to engage in education programs regarding risk. “The agency has made some investment in this, but clearly it is not enough.”
Sept. 19, 2011 – Center for Drug Evaluation and Research (CDER) Director Janet Woodcock announced in an e-mail to CDER staff that as part of the reorganization of the Office of Medical Policy (OMP) into a Super Office, the former Division of Drug Marketing, Advertising and Communications has been reorganized and elevated into a new Office of Prescription Drug Promotion (OPDP), which divides promotional oversight into two divisions, one for professional promotion and one for direct-to-consumer (DTC) promotion.
“This reorganization will leverage OPDP’s resources and processes to provide for the highly effective oversight of prescription drug promotion,” Woodcock states.
“Maybe this is a good omen,” remarked John Kamp, executive director, Coalition for Healthcare Communication. “It took 18 months to get this reorganization approved. Let’s hope that the Internet and Social Media rules show up soon.”
The new OPDP, still under the direction of Thomas Abrams, consists of an Immediate Office, the Division of Professional Promotion (DPP), and the Division of Direct-to-Consumer Promotion (DDTCP). The new structure “will help prevent misleading promotion about prescription drugs and enhance the quality of communications about prescription drugs and other health information developed by companies,” according to Woodcock.
Leadership of the OPDP also includes:
- Mark Askine, Associate Director, Office of Prescription Drug Promotion
- Marci Kiester, Associate Director of Operations, Office of Prescription Drug Promotion
- Catherine Gray, Acting Director, Division of Professional Promotion
- Robert Dean, Acting Director, Division of DTC Promotion
The Office of Medical Policy also encompasses the Office of Medical Policy Initiatives, led by Rachel Sherman and her Deputy, Kathleen Uhl. Janet Norden is Associate Director for Regulatory Affairs. OMP plays a critical role in directing medical policy programs and strategic initiatives.
Enter CHC Contest for New OPDP Nickname
The Coalition for Healthcare Communication (CHC) will award autographed copies of both volumes of the great coffee table book, Medicine Avenue: The Story of Medical Advertising in America to the best new nickname for the FDA OPDP. Enter today by commenting below. Entries will be judged and announced by the Executive Committee of CHC. More details will be announced soon.
The first volume of Medicine Ave was published in 1990 by the Medical Advertising Hall of Fame. Medicine Ave 2 chronicles the history of the industry from 1990 through the present. In addition to featuring hundreds of examples of the best work since 1990, the publication covers the evolution of the modern agency in terms of creativity, structure, and client relationships, and further details the legal and governmental framework that has shaped the industry, the evolution of the science, the globalization of medical advertising, mergers and acquisitions, the impact of digital communications, the rise of DTC advertising, the impact of technology, and the changing role of medical publishing.
More than a dozen industry experts contributed to the publication, lead by a
publications committee composed of legendary agency CEOs Ron Pantello (Lally, McFarland, Pantello), John Kallir (Kallir, Phillips, Ross), and Harry Sweeney (Dorland, Sweeney, Jones) and Euro RSCG creative head Julien Jarreau. The work of dozens of leading healthcare advertising agencies is shown to illustrate the caliber and diversity of the industry’s work.
Be nice, now. Have fun, but be good. ;-)
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
By John Kamp, Coalition for Healthcare Communication Executive Director
Sept. 13, 2011 — Debates over health care and related marketing costs are certain to arise as the Congress and White House struggle to reduce the deficit, stimulate the economy and prepare for the upcoming elections. Meanwhile, the IMS Supreme Court decision is causing a stir in industry and in the courts.
Here are four things you need to know:
1. The IMS Supreme Court decision already is shaking up pending court cases involving FDA and HHS-IG enforcement of medical marketing regulations. As you know, the IMS decision undermines FDA’s ability to ban truthful information by drug companies on off-label uses of drugs. Industry and First Amendment lawyers are closely watching the federal Second Circuit Court of Appeals, a court immediately under the Supreme Court. The IMS case has become central to the appeal of Alfred Caronia, a drug representative being charged by the United States with the crime of including off-label information in sales presentations. In a decision expected soon, the appellate court could agree with Caronia’s lawyers that uttering truthful off-label information cannot be made a crime. Several parties filed special comments based on the IMS decision (see Caronia Amicus Brief). One of the most important of these came from the Medical Information Working Group (MIWG), a coalition of seven medical product manufacturers who recently filed the attached Citizen Petition with FDA asking for clearer off-label regulations. Together, the Supreme Court decision, the MIWG Citizen Petition, and the upcoming U.S. v. Caronia decision could lead to dramatic changes in medical marketing regulation and enforcement. I will be moderating a panel on these developments at the Sept. 23 FDLI meeting (see FDLI Marketing Conference Agenda). The panel includes Harvey Ashman, General Counsel of IMS, Diane Bieri, General Counsel of PhRMA, and Bert Rein of the Wiley Rein law firm, who served as lead counsel in the Washington Legal Foundation case.
2. The deficit super committee is gearing up and quickly must come up with significant budget cuts or tax increases. While industry fared relatively well in last year’s Affordable Care Act, new money must be found and no income source will be overlooked. Indeed, the Advertising Coalition members were not surprised recently when a group targeted the medicines industry even before the committee’s first meeting. The recommendation came from the Pharmaceutical Care Management Association (PCMA), representing PBMs. PCMA sent the attached letter directly to the leaders of the deficit super committee with several suggestions for saving money by suppressing the use of branded drugs, including elimination of the tax deduction for DTC advertising. The Ad Coalition is working with industry groups, including PhRMA and media associations, to address this and other possible proposals.
3. Congressional action on health care marketing issues most likely will arise as part of PDUFA V, the appropriations bill that must pass by October 2012 to enable funding of the FDA. The FDA draft of that legislation has been in the works for more than a year and is about to be sent to Congress. The current draft includes several modifications
to FDA approval processes, including new fees for devices and generics, but no proposals for additional marketing rules. Knowing this, a coalition of consumer groups made a last-minute plea to HHS Secretary Kathleen Sebelius to include more marketing restrictions. We don’t expect HHS to agree, but know that the consumer groups will press for these changes on Capitol Hill this year and next. You will be hearing much more about PDUFA V before the bill becomes law.
4. As we wait for Sunshine provisions of the Affordable Care Act to be announced by HHS this month (http://www.cohealthcom.org/2011/03/28/coalition-stakeholders-weigh-in-during-cms-%e2%80%9csunshine-act%e2%80%9d-call/), we not only are seeing the media future in the age of transparency but are getting much better prepared to handle the media spotlight. Last week, ProPublica and local media outlets filed their second wave of stories publishing data on individual doctors who have received payments for working with us and our medical clients. Although many local news outlets picked up the ProPublica material, reporters often contacted the industry and doctor groups, which worked aggressively to provide background and additional context to the stories. The industry owes special thanks for this to both PhRMA and the Association of Clinical Researchers and Educators (ACRE) (http://www.cohealthcom.org/2011/09/08/propublica-reporters-urged-to-provide-context-and-meaning-to-payment-disclosures/).
And, as always, stay tuned.
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; firstname.lastname@example.org).
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.”
Sept. 6, 2011 – The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) issued three Warning Letters and nine Untitled Letters in the past four months, according to DDMAC officials speaking at an Enforcement Webinar held Aug. 25. The Webinar was part of a DDMAC pilot program to allow stakeholders to better understand and learn from the enforcement actions the agency issues in a recent quarter.
The promotional materials that were the subject of these enforcement actions included one magnet, one detail aid, one booklet, one flyer, two flashcards, and six Web sites (one of which was a YouTube video). Three of these alleged violations came to DDMAC’s attention through complaints under its “Bad Ad” program.
“These DDMAC programs give drug sponsors and their marketing partners clear guidance on the enforcement priorities of the FDA,” said John Kamp, executive director of the Coalition for Healthcare Communication. “DDMAC is responding to complaints elicited through the Bad Ad program. Marketers must pay attention to Internet promotions and detail aids that could violate FDA policies.”
The DDMAC Webinar detailed several specific violations that drew Untitled and Warning Letters in the last few months:
- Omission/minimization of risk
- Unsubstantiated claims (e.g., unsubstantiated superiority claims)
- Broadening of indication
- Overstatement of efficacy
- Omission of material facts
- Promotion of an investigational drug
- Misleading claims (i.e., those related to dosing, compliance)
- Failure to submit under Form 2253
In a Warning Letter issued for promotion of an investigational drug on the company’s Web site, DDMAC explains that it finds the promotion “concerning from a public health perspective” because it suggests that the drug “is safe and effective when the product has not been approved by the FDA and the promotional claims made have not been demonstrated by substantial evidence or substantial clinical experience.”
DDMAC has said it
is holding these “focused Webinars” to “support DDMAC’s mission to protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.”
On Sept. 26 and 27, Tom Abrams, head of DDMAC, and representatives of the other marketing enforcement centers at the FDA will be making additional enforcement presentations at the FDLI marketing meeting in Washington, D.C. (link to the FDLI Marketing Conference Agenda). On Tuesday, Sept. 27, Kamp will be moderating a luncheon panel with industry legal experts addressing these issues and the legal ramifications of the IMS Supreme Court decision issued in June.