May 24, 2012 – While industry awaits the final regulations to implement the Physician Payment Sunshine Act it can gain a better understanding of the Act’s implications at a June 27 Drug Information Association Annual Meeting session moderated by Coalition for Healthcare Communication Executive Director John Kamp.
During this session, expert panelists will discuss the Sunshine Act regulations’ likely impact – both burdens and benefits – on public health and relevant stakeholders, including government, lawyers, accountants, pharmaceutical and medical device companies, researchers, investigators, physicians and others.
DIA session attendees will hear from the following panelists, in addition to Kamp:
John J. Lewis, MA
Vice President, Public Affairs
Association of Clinical Research Organizations
Thomas P. Stossel, MD
Director, Translational Medicine Unit and Center for
Medical Innovation
Brigham & Women’s Hospital
Sandra J P Dennis, JD
Deputy General Counsel
Biotechnology Industry Organization (BIO)
Daniel Carlat, MD
Director
Pew Prescription Project
Marjorie E. Powell, JD
Senior Assistant General Counsel
PhRMA
The DIA annual meeting will be held June 24-28 in Philadelphia. To register, go to: diahome.org/dia2012. Coalition Web site readers will receive a 10% discount on their registration by entering DIA2012SP.
May 23, 2012 – At an FDA meeting held last week to explore more effective ways of including patient input in regulatory decisions regarding drug, device and biological products, the agency made it plain to patients, caregivers, patient advocates and patient advocacy groups that it wants patient perspectives to be included in the process.
“This initiative, led by Center for Drug Evaluation and Research Director Janet Woodcock, M.D., is the second of two ‘game changer’ proposals that put consumers and marketing at the center of the discussion, and potentially at the center of the drug approval and use processes,”
said Coalition for Healthcare Communication Executive Director John Kamp, who explained that earlier this year, Woodcock began a discussion about the creation of a third class of drugs where initial prescriptions and refills could sometimes be filled without a physician (http://www.cohealthcom.org/2012/04/30/proposed-otc-drug-distribution-would-expand-patient-access/).
“Together, these proposals mean that FDA is fully recognizing the power of the patient and putting patients at the center of health care in America,” Kamp said.
In a notice published before the May 18 Inaugural FDA Patient Network Annual Meeting, the FDA stated that “establishing a means for obtaining input from patients and patient advocate groups will allow FDA to further enhance its benefit-risk assessment in regulatory decisionmaking.”
Further, the agency said that “patients who live with a disease have a direct stake in the outcomes of the review process and are in a unique position to contribute to the weighing of benefit-risk considerations that can occur throughout the medical product development process.”
At the meeting, CDER’s Woodcock noted that in general, regulation is “the result of a societal consensus that limits the actions or speech of certain parties in society.” She added that although science can inform risk-benefit decisions, it “doesn’t tell us if the benefits outweigh the risks. That’s a value judgment.”
The FDA set forth junctures in the drug approval process where it believes that consumer/patient input would be most valuable: (1) the pre-Investigational New Drug (pre-IND) stage and (2) the pre-New Drug Application (pre-NDA) stage. Input during the pre-IND period is important, according to CDER officials, because such input would fill information gaps about treatment benefits for specific conditions. At the pre-NDA stage, patients could provide input regarding the new therapy’s effectiveness and tolerability.
It appears that patient input also would give the agency additional information about which treatments – drugs or other modalities – are available to and working for patients. This information could help the agency enhance its value judgment-making capability.
“Acetaminophen … very rarely causes devastating liver failure, and some people say that even a rare risk is unacceptable,” Woodcock said. She explained that knowing more about a drug’s impact on a population can help the agency with its decisions, citing a multiple sclerosis treatment that helped many patients but potentially could put certain individuals at risk of progressive multifocal leukoencephalopathy. “The MS community rose up to help keep this drug on the market,” she said.
The agency currently is preparing a list of 20 diseases/conditions for which it will gather patient input under the Prescription Drug User Fee Act V. Incorporating patient perspectives into the regulatory review process is a “major task for FDA over the next several years,” according to Woodcock.
“At this juncture, we need to work together,” she said. “The bottom line is to improve the diagnosis of illness and alleviate suffering.”
By John Kamp, Executive Director, Coalition for Healthcare Communication
May 18, 2012 — Sen. Claire McCaskill (D-Mo.) told a group of senior advertising executives this morning at the AAAA’s New York offices that elimination of the deduction for marketing expenses remains possible, especially during the “lame duck” session of Congress following the November election.
“I wish I could tell you that you don’t need to worry, but the Congress needs to identify $4-5 trillion in combined spending cuts and new revenues,” McCaskill said. “With the deduction for popular items such as the home mortgage deduction on the list, you can bet relatively obscure items with be there, too,” she remarked.
McCaskill reminded the heads of the ANA, the AAAA, the Internet Advertising Bureau, the Coalition for Healthcare Communication and others that after the failure of the SuperCommittee to come up with the needed cuts, several “automatic triggers” will take effect on Jan. 1, 2013, that reduce funding for defense, Medicare, and other programs, as well as eliminate the Bush tax cuts.
The senator opened her discussion focusing on the multiple privacy proposals she said would “blow a hole in the profitability of Internet advertising business in this country.” She further opined that “neither the White House, the FTC, nor many senators understand how dangerous these proposals are and could easily vote for them.” She also noted that several private companies, including
Mozilla Firefox, are working on browsers that effectively “visualize” data gathering on a browser and how to avoid it.
For more information on this session, please contact John Kamp at: jkamp@wileyrein.com
May 11, 2012 — In the wake of the June 2011 U.S. Supreme Court decision in IMS v. Sorrell, which stated that a Vermont law violated the First Amendment because it restricted the sale of prescription drug data for commercial marketing purposes, the New Hampshire legislature recently amended a similar law on its books by striking “references to prohibitions on disseminating ‘prescriber-identifiable data’” and bolstering patient confidentiality protections, according to an article posted May
10 on Pharmalot.com.
The article quotes industry attorney Arnie Friede, who said: “The scope of the new law is not clear, how it would work in practice is not clear, whether in practice it would allow legitimate health care and insurance operations to be undertaken and completed properly while still retaining the apparent objective of the new law … is unclear.”
To read more, go to: http://www.pharmalot.com/2012/05/a-state-grapples-with-the-infamous-data-mining-case/
May 7, 2012 — The Centers for Medicare & Medicaid Services (CMS) stated on the CMS blog that following its receipt of more than 300 comments from stakeholders, it would not require manufacturers and group purchasing organizations to submit data regarding payments or gifts to physicians until Jan. 1, 2013, at the earliest. This Physician Payments Sunshine Act requirement was published in a Dec. 19, 2011, CMS proposed rule.
CMS also states in the full text of the announcement (printed below) that it plans to publish a final rule later this year. For the Coalition’s views on the Sunshine Act proposed rule, please refer to the Coalition for Healthcare Communication Sunshine Act Comment.
CMS Announcement:
On cialis buy online December 19, 2011, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule implementing the Physician Payments Sunshine Act, which was included as section 6002 of the Affordable Care Act of 2010. This provision will provide important transparency in requiring reporting of payments or gifts to physicians, and physician ownership and investment interests. During the 60 day comment period, CMS received over 300 comments from a wide range of stakeholders.
CMS is committed to addressing the valuable input received during the comment period, and to ensuring the accuracy of the data collected. In order to provide time for organizations to prepare for data submission and to sufficiently address the important input we received during the rulemaking process, CMS will not require data collection by applicable manufacturers and applicable group purchasing organizations before January 1, 2013.
CMS intends to release the final rule later this year. This timing will provide CMS with additional time to address operational and implementation issues in a thoughtful manner, and the ability to ensure the accuracy of the data that is collected.
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May 7, 2012 – Many of the alleged violations cited by the Office of Prescription Drug Promotion (OPDP) in five Untitled Letters and one Warning Letter during the first quarter of 2012 are the same violations the agency has cited in the past. Th
ese violations include:
- Omitting or minimizing risk information
- Making unsubstantiated claims, including superiority claims
- Overstating efficacy
- Omitting material facts
- Promoting unapproved uses
- Broadening indications
Speaking at an April 30 OPDP Webinar on Q1 enforcement actions, OPDP Regulatory Counsel Bryant Godfrey said “quality is improving, but there is still room for improvement across the board. Some companies appear to be getting the message while others don’t.”
The sole Warning Letter issued during this time period was sent to Teva Pharmaceuticals USA for its drug COPAXONE. In the March 14 Warning Letter, OPDP states that exhibit panels and Web pages promoting the drug “are false or misleading because they overstate the efficacy, present unsubstantiated claims, broaden the indication of Copaxone, omit and minimize important risk information associated with the drug, present unsubstantiated superiority claims, and omit material facts.”
Further, the letter states that these alleged violations “are concerning from a public health perspective because they suggest that Copaxone is safer or more effective than has been demonstrated by substantial evidence or substantial clinical experience.”
The FDA took issue with promotional claims related to the duration of treatment experience and years of drug safety for Copaxone, which are not supported on the drug’s package insert (PI). The PI did not support the cited claims, according to OPDP Regulatory Counsel Julie Chronis. “The studies that were cited in the piece did not constitute substantial evidence. These studies were extension, open-label studies,” she said.
OPDP Regulatory Counsel Ernest Voyard further explained that these materials presented information out of context. “This is one of those situations where context kind of matters,” he said. The promotional claims suggested 20 years of use by a single patient not simply that the drug had been on the market for 20 years, he indicated. Chronis added that even when companies cite from the PI, they still have to provide appropriate context.
When asked whether industry should submit diagrams and layout of exhibit booth panels via Form FDA 2253, Godfrey responded, “Yes. The more you can help us out the better.”
One attendee asked why a chart cited in a March 13 Untitled Letter to Biogen Idec regarding AVONEX was problematic, considering that the information used to compare Avonex with other drugs in its class was true. “Even though the information portrayed in the chart was true, it was not complete, because risk information for Avonex and the other drugs was omitted,” Chronis said.
Another member of the audience asked for guidance on when a company could properly discuss a specific use beyond the general indication, a problem cited in a March 30 Untitled Letter to Ferring Pharmaceuticals Inc. for FIRMAGON. “When a drug has a general indication, it can be problematic to discuss those specific uses that have not specifically been approved, for a number of factors,” Voyard said. Companies need to have specifically studied and have substantial evidence to back up those uses, he noted.
Several questions were posed to the
OPDP panel regarding the use of case studies in promotional materials, in light of a Jan. 9 Untitled Letter to Novartis Oncology for GLEEVEC. In the letter, the agency took issue with the use of a promotional case study because although it may have been an accurate representation of one patient’s treatment experience, it found no evidence to suggest that all patients would have a similar experience. “FDA is not aware of substantial evidence or substantial clinical experience to support this suggestion,” the OPDP letter states.
Voyard clarified that patient case studies used for promotional purposes should reflect the general use of the product as listed in the PI. “Companies shouldn’t pick extreme cases that show a clear benefit and hide the risk. It should be an accurate reflection of what patients should expect,” he said. “That being said, it doesn’t have to be a middle-of-the-road patient either, but it should reflect what’s expected.”
Another attendee asked why it was not advisable to discuss a patient that did exceptionally well in a case study. Voyard replied that “the exceptional patient is an outlier, and any outlier can be problematic. A [case study] patient has to experience some of the benefits and some of the risks – not necessarily every benefit and every risk – but the [case study patient] should address the general experience,” he noted. “Outliers are probably dangerous.”
When asked whether companies should stop using case studies, Chronis replied, “We don’t discourage it. We just want to see it done in an appropriate manner.”
Reiterating a sentiment conveyed in the 2011 Q4 OPDP Enforcement Webinar, Godfrey said that “voluntary compliance is key.”
May 7, 2012 — The American Recovery and Reinvestment Act (aka, “the stimulus package”) provided AHRQ with $29.5 million for a program on academic detailing and the “communication of CER results to physicians.”
One contract, for $11.7 million, went to Total Therapeutic Management (TTM) and is specifically intended for physician outreach and education.
(TTM is a company that focuses on chart abstraction, data mining, and physician and patient education for a predominantly commercial client base – health plans, pharmacy benefit managers, employers, and pharmaceutical companies, etc.)
The goal of this contract is to integrate AHRQ’s comparative effectiveness research, products, and tools into clinical practice through 9,000 on-site, face-to-face visits with clinicians, nurses, health plan formularies, benefit managers, and other healthcare professionals.
I recently interviewed the Barry Patel, the president of TTM. Here are some snippets from our conversation:
How will the government decide which doctors are to be visited? Will “high prescribers” of on-patent medicines be on a priority list?
TTM’s top priority is “high volume” practices across 150 Metropolitan Statistical Areas (MSAs). So, rather than focusing on offices with disproportionately high negative patient outcomes, the government is directing its efforts against those doctors who are high prescribers – which is a pretty good indicator about what government detailing is all about – decreasing cost rather than improving care.
When it comes to government detailing (at the taxpayers’ expense), what are the metrics for success?
According to Mr. Patel, the only metrics are whether or not a physician says the sessions have been useful and asks the detailer to come back to discuss other topics. In other words, the metrics are subjective and anecdotal – not clinical.
Interestingly, Mr. Patel doesn’t even agree with either the term academic detailing or counter detailing. “We aren’t counter anything. We’re not there to undo anything. It’s not good versus bad. Our visits aren’t details, they’re the beginning of a process.” And, as far as “academic” goes, Mr. Patel uses that term because “that’s the phrase AHRQ uses and placed in the contract. Our people are patient-centered outcomes consultants, PCOCs.” And “his people” are largely pharmacists and nurses.
A former Merck employee, Patel likens his PCOCs more to pharmaceutical company Medical/Science Liaisons (MSLs) than field representatives. “They’re not discussing product-specific information, but the findings of comparative effectiveness studies.”
How does TTM schedule their appointments with targeted physicians?
According to Mr. Patel, when his “outreach experts” phone physicians to request appointments, the fact that the meeting will result in CME credits is always mentioned. Would a pharmaceutical company be permitted to offer such an enticement? Would such an offer be “sunshine-able” under state and federal guidelines? And, if so, why don’t government detailers have to share the details of their valued benefactions?
Interestingly, according to the Accreditation Council for Continuing Medical Education (ACCME), government is exonerated from having a commercial interest. (A commercial interest is any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients.)
Our nation’s single largest payer, Uncle Sam, is not deemed to have a conflict of interest when it comes to designing and providing physician CME.
What’s wrong with this picture?
[Editor’s Note: Peter Pitts is president and co-founder of the Center for Medicine in the
Public Interest. This article appeared May 3 on DrugWonks.com. Read more from Pitts on Government Detailing.]
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