Nov. 22, 2011 – The Center for Medicine in the Public Interest (CMPI) believes that if politics takes priority over the public health during negotiations for the reauthorization of the Prescription Drug User Fee Act V (PDUFA V), “bad things” will happen. To prevent that outcome, CMPI is leading a panel discussion, entitled “Defining the Future of the FDA: PDUFA V and Beyond,” on Tuesday, Nov. 29.
“When politics trumps public health, patients suffer,” said CMPI President Peter Pitts. “Properly constructed, PDUFA V can help the FDA to aggressively pursue its mission of protecting and advancing healthcare in the United States. Politics has no place. It’s time for all parties concerned to act as colleagues and do the right thing,” according to Pitts.
CMPI’s panel discussion will be held from 12 PM-1:30 PM in Rm. 2168 (Gold Room) of the Rayburn House Office Building on Nov. 29. The panel includes some of the nation’s top experts in PDUFA and FDA reform, as follows:
- Peter Pitts (moderator), Former FDA Associate Commissioner
- Hon. Michael C. Burgess, M.D., Vice Chairman, Subcommittee on Health, U.S. House of Representatives
- Vincent Ventimiglia, Jr., Former Assistant Secretary for Legislation at the U.S. Department of Health & Human Services; Senior Vice President in the Health and Life Sciences Practice at B&D Consulting, a division of Baker & Daniels
- Paul T. Kim, Former Deputy Staff Director for health policy for Sen. Edward M. Kennedy; Partner at Foley Hoag LLP in the Government Strategies Practice
- Michele J. Orza, Former Assistant Director of the Health Care Team at the Government Accountability Office; Principal Policy Analyst at the National Health Policy Forum
- Tim Franson, Former Vice President, Global Regulatory Affairs, Eli Lilly & Co.; President USP Convention; Senior Vice President, Health and Life Sciences Sector, B&D Consulting.
For more information and instructions regarding how to RSVP, please reference the PDUFA Event Invite.
By John Kamp, Executive Director, Coalition for Healthcare Communication –
Nov. 7, 2011 – Until the research labs and the FDA approval process deliver more medicines, neither patients nor industry can start singing “Happy Days Are Here Again.”
But, the report last week from the FDA Center for Drug Research and Evaluation does demonstrate substantial progress, at least for specialty drugs, orphan drugs and even a few larger-scale oncology medicines.
Indeed, despite rumors to the contrary, medical innovation is not dead. Thanks to continued research investment by industry and a clear commitment by the FDA to approve drugs while effectively managing risk, medicines for cancer and other increasingly difficult conditions are being approved and used to both extend the lives and improve the quality of life of patients.
The FDA’s report card for drug approvals in the past year looks pretty good. Although most of the approvals are for drugs with relatively small markets, each one denotes progress. The agency approved 35 innovative new drugs – the second-highest number of new drugs approved in a given year during this decade. Further, 24 of the 35 new drug approvals occurred in the United States “before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines,” according to an FDA press release touting the results.
And, while industry and patient groups may not be ready for a ticker-tape parade, the FDA report credited the following for the increase in approved new drugs:
- Expedited approval authorities;
- Flexibility in clinical trial requirements; and
- Resources collected under the Prescription Drug User Fee Act.
“Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients,” said Commissioner of Food and Drugs Margaret Hamburg, M.D. “We are committed to working with industry to promote the science and the innovation it takes to produce breakthrough treatments,” she stated.
Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President for Scientific and Regulatory Affairs Dr. David E. Wheadon expressed a similar sentiment, issuing the following statement regarding the FDA’s report: “The FDA’s report on new drug approvals – finding that 35 new molecular entities received FDA approval in fiscal year 2011 – demonstrates the shared commitment of biopharmaceutical research companies and the agency to medical progress and patient care.
“By approving these new medicines, FDA is helping to provide patients with access to new medicines that offer hope in meeting unmet medical needs. Of course, the tremendous value of these advances – and FDA’s review and approval of them – underscores the importance of expedient approval of a clean Prescription Drug User Fee Act (PDUFA), which will help provide the resources needed to allow FDA to continue to serve, and enhance, its essential function.”
PhRMA’s Dr. Wheadon put his finger on it. Congress can pass a clean PDUFA bill that enables efficient scientific reviews using user fees. Or it can make it an “ugly Christmas tree,” as they call it on Capitol Hill, loading it up with so many ornaments that the whole thing falls over from the dead weight. Several nasty ornaments are being readied by “consumer groups,” including additional marketing and “conflict of interest” regulations. Members of Congress must reject these to enable both the innovation and communication that brings drugs to patients.
Most importantly, for patient’s sake, industry/government collaborations must be fostered. It is confluence of interest that makes medical innovation progress. Let’s keep up the momentum.
Oct. 24, 2011 – After the U.S. Supreme Court struck down speaker- and content-based restrictions in Sorrell v. IMS Health, legal experts, drug manufacturers and other industry interest groups are testing the waters to determine whether that opinion leaves the door open for new challenges to certain FDA regulations, specifically the agency’s ban on most off-label promotion, according to an article in The RPM Report.
Kate Rawson writes in the October issue of the publication that the Sorrell decision could lead the U.S. Court of Appeals for the Second Circuit – the same court that “reversed a lower court decision in Sorrell and deemed Vermont’s data mining restrictions to be a violation of the First Amendment” – to overturn the conviction of Alfred Caronia, a sales representative who was charged with promoting a drug for an off-label indication. In light of the Sorrell decision, the Second Circuit considering Caronia’s appeal asked for briefs regarding the relevance of the Sorrell opinion on this case.
The government dismisses the argument that Sorrell affects “the constitutionality of Caronia’s conviction.” The government also denies that FDA regulations lack the “coherence and clarity” to provide manufacturers with the “guidance they need on off-label promotion.”
The Coalition’s John Kamp is quoted in this comprehensive article covering the current state and future of off-label promotion. Read the full article, “Off Label Changes Coming? Sorrell Ruling Prompts New Legal Challenges,” courtesy of The RPM Report.
Oct. 18, 2011 – A case filed by Par Pharmaceutical, Inc. against the FDA seeks to preserve Par’s First Amendment right to provide truthful information to physicians and other healthcare providers about the off-label use of Par’s prescription drug, Megace® ES, which is approved for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients diagnosed with acquired immunodeficiency syndrome (AIDS).
In addition to prescribing Megace ES on-label to treat their AIDS patients, physicians frequently prescribe the drug off-label to treat wasting in non-AIDS, cancer, and geriatric patients. FDA regulations call for Par to refrain from speaking about the approved use of Megace ES to physicians who may prescribe the drug for unapproved uses.
According to a statement issued by Par, it hopes to “elicit tailored and constitutionally permissible regulatory guidance to ensure that physicians may be kept abreast of valuable, off-label information about prescription drugs to aid in their provision of quality and informed patient care.”
Coalition for Healthcare Communication Executive Director John Kamp is quoted in an article on the filing in Policy and Medicine, saying, “Par’s challenge goes directly to the heart of FDA’s jurisdiction to censor truthful speech by drug sponsors. After the Supreme Court decision in IMS, someone was bound to bring it. Now, the whole industry will be watching.”
To read the full Policy and Medicine article, go to: http://www.policymed.com/2011/10/phar-pharmaceuticals-vs-fda-calling-for-truthful-speech-vs-fda-approved.html
As always, please feel free to post your thoughts on this important issue below.
Oct. 11, 2011 – The FDA is seeking to provide more complete compliance and enforcement data to the public and regulated industry, according to a document issued last week by the agency’s Transparency Task Force.
The document, “Draft Proposals for Public Comment to Increase Transparency by Promoting Greater Access to the Agency’s Compliance and Enforcement Data” includes recommendations “focused on making FDA’s compliance and enforcement data more accessible and user-friendly, and they are part of our ongoing efforts to increase the transparency of FDA’s operations and decision-making,” the agency stated in a press release.
Among the proposals is a recommendation that the FDA “explore ways to better utilize social media, such as Facebook and Twitter, as well as Agency-sponsored webinars and automatic e-mail notifications,” to better communicate with its constituents (Draft Proposal 7).
The task force also calls for the agency to look for ways to better present its compliance and enforcement data graphically and better utilize mobile Web applications to draw more users to its compliance and enforcement Web pages (Draft Proposal 3). The document states that the agency already has implemented this proposal “by developing a centralized webpage where stakeholders can easily access” press releases regarding the filing and resolution of enforcement actions filed by the Department of Justice on the FDA’s behalf.
The FDA also states it has placed “a number of enforcement-related datasets on the Data.gov website.” Further, the agency has launched a redesigned Web page and a phone app to permit the public to search easily for enforcement information.
Other proposals direct the FDA to focus on more timely data disclosure, develop user interfaces, integrate compliance and enforcement data, determine whether additional data compilations or analysis would “increase transparency or better inform the Agency’s own compliance efforts,” and decide if providing appropriate context for the noncompliance and enforcement data that it discloses might avoid misinterpretation or misuse of those data.
Comments on the draft proposals will be accepted until Dec. 2 via http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=10;po=0;D=FDA-2009-N-0247. The FDA Commissioner will determine whether to adopt any of the proposals by Jan. 31, 2012.
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
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.
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:
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