Dec. 22, 2011 – As industry groups focus on the details of last week’s proposals from HHS to implement the Sunshine Act provisions of the Affordable Care Act, veteran journalist Cole Werble in PrevisionPolicy recently made a set of predictions on how Sunshine may change the marketing spend of the medicines industry.
Among several predictions, Werble states that “the added burdens and specific rules of the disclosure provisions will continue to nudge pharma budgets away from the broad dispersal of speaking and research funds for practitioners and towards other forms of spending.”
The article highlights key provisions in the proposed regulations that will have an impact on pharma marketing and calls out pitfalls in the proposal.
Meanwhile, the Coalition for Healthcare Communication and other industry groups are sharing information and coordinating efforts to provide robust comments to HHS on many of the details in the Notice of Proposed Rulemaking published Dec. 19 in the Federal Register.
“While HHS wisely decided to postpone implementation, there are several devilish details in the proposed rules,” explains Coalition Executive Director John Kamp. “For example, the proposed rules inappropriately expand the scope of the statute, sweeping in activities not intended by Congress. In particular, many indirect payments to doctors for REMS and certified CME should not be included.”
Many of the relevant details in the proposal are outlined in the Medical Policy Blog published by Thomas Sullivan of Rockpointe Communication: http://www.policymed.com.
For more information on the proposed rule and to join the industry discussion on how to effectively participate in the HHS rulemaking process, contact John Kamp at firstname.lastname@example.org. Comments must be sent to the Centers for Medicare & Medicaid Services by Feb. 17, 2012.
Dec. 15, 2011 – The Centers for Medicare & Medicaid Services (CMS) issued its long-awaited Proposed Rule for implementing the Physician Payments Sunshine Act yesterday, just a day before the Senate Special Committee on Aging was slated to hold a hearing about the need for the “timely release of regulations” and the impact on industry and consumers of CMS missing its Oct. 1, 2011, regulation deadline.
“It’s high time the affected communities got to see the proposed rules,” remarked Coalition Executive Director John Kamp. “Obviously, CMS listened to concerns of the Coalition and others in developing this proposal and provided more reasonable deadlines for comment and compliance.”
The statutory deadlines had been an important sticking point for industry and others. Until today, industry was expected to begin data collection starting Jan. 1, 2012, and report it on March 31, 2013. Under yesterday’s notice, data collection will not begin until after final regulations are issued. Data submission is slated to occur on the original date of March 31, 2013, but CMS is proposing that only a partial year’s data will need to be reported.
As the details of the national Sunshine Act rule emerge and when the resulting data eventually are released, stakeholders must play a role in how they are interpreted, according to Kamp. “Our most important job is ensuring that our clients, healthcare providers and patients get past the headlines, understand the underlying issues and move forward,” he added.
“It’s time for politicians and the press to stop the finger pointing and get us all refocused on patient care,” he said, because “collaboration among medical providers, researchers, industry and government is key to patient care. It must be encouraged.”
For additional background on what the industry must do to fully prepare for the new rules see the feature story Kamp wrote on the Sunshine Act in Communiqué this fall (“Don’t Get Burnt”: http://www.communiquelive.com/features/archive/2011/september/dont_get_burnt).
Among other comments, Kamp notes in the piece that although transparency is important, the value of communications between industry and medical professionals must be managed carefully. He recommends several steps need to be taken to help patients, policymakers and the press better understand the data when published. “Doctors with strong industry ties are better informed,” Kamp stated, adding that these relationships should be considered “a credential, not a cause for concern.”
Meanwhile, today’s hearing has now been postponed as the Act’s developers, Sen. Herb Kohl (D. Wis.) and Sen. Charles Grassley (R-Iowa), take time to review the proposed rule, which is slated to be published in the Dec. 19 Federal Register.
“The Sunshine Act guidance is a welcome, if late, step toward ensuring that the financial links between physicians and the drug, biologics and medical device industries are transparent,” Kohl said in a statement postponing the hearing to early 2012. “As we move forward, it’s vital that stakeholders have a voice in this process to ensure transparency and accountability in our health care system.”
Both Kohl and Grassley sent a letter to CMS Administrator Donald Berwick expressing their “severe disappointment” that the agency missed the Oct. 1 deadline to issue regulations as mandated by the Affordable Care Act.
“The completion of the guidance is good news,” Grassley said. “It came after a lot of follow-up from Sen. Kohl and me to find out the status and to press for results from CMS. It shows Congress has a responsibility not just to make the laws but also to see that they’re carried out as intended. Companies need this guidance to do their part.”
CMS will be accepting comments on the Sunshine Act Proposed Rule until Feb. 17, 2012. To view a comprehensive summary of the proposed rule, go to: http://www.policymed.com/
Dec. 14, 2011 — The FDA’s Office of Prescription Drug Promotion (OPDP) will be presenting a Webinar next week to review the enforcement actions it took during this quarter. The Enforcement Webinar – the third the agency has hosted this year – will be held on Dec. 19, 2011, from 2:30 p.m. to 3:00 p.m. (ET). Viewers can begin submitting questions 30 minutes prior to the Webinar start time.
These Webinars are offered under a pilot program “in which OPDP will give our stakeholders a chance to directly communicate with the Agency on clarifications or questions about the Warning Letters and Untitled Letters issued by OPDP in a given quarter.” The Dec. 19 Webinar will cover Warning Letters and Untitled Letters issued from September 2011 to December 2011.
The Webinars are part of a pilot program that is intended to “support OPDP’s mission to protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.”
Meeting details provided by the agency are listed below:
To join the meeting:
Conference Number(s): 301-796-2700
Participant Code: 252580
If you have never attended a Connect Pro meeting before:
Test your connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
Get a quick overview: http://www.adobe.com/go/connectpro_overview
Dec. 12, 2011 — Facing a need to decrease spending and boost revenues, the federal government will continue to target the pharmaceutical industry in 2012, according to a recent report in the December issue of Medical Marketing & Media. In the report, “Outlook 2012: Detailing DC,” author Matthew Arnold states that although pharma is fighting back, it faces a number of significant challenges and needs “to make the case for itself as a source of good jobs and a center of American innovation.”
The comprehensive report draws heavily from remarks by Coalition Executive Director John Kamp and others at the November meeting of leading members of the Coalition, held in Washington, D.C. Arnold lists several controversies likely to arise in 2012, including:
- Proposals to end or limit the tax deductibility of communication and marketing by pharma and other companies
- Potential imposition of additional discounts (“rebates”) on medicines sold to the government
- Efforts to reduce patent protection for biologics from 12 years to seven years
- Possible multiple “riders” to legislation to fund FDA under the Prescription Drug User Fee Act V (PDUFA V)
- Possible guidance from the FDA on social media
- Rules from HHS’ Centers for Medicare & Medicaid on the Sunshine Act
Arnold suggests that ongoing challenges to the FDA off-label marketing restrictions may provide some regulatory clarity for pharma marketers. “FDA’s policy on off-label uses of approved drugs is being challenged on First Amendment grounds,” says Arnold. Among other issues, many industry lawyers see a “potential disarming of the rationale behind the jaw-dropping settlements for off-label marketing,” Arnold states.
Drawing on Kamp’s November briefing, Arnold notes that with Wall Street now in the public’s crosshairs, the pharma industry is getting less negative attention, and health care marketing is becoming less of a target than medical product safety. “We are still in the post-Vioxx era,” Kamp said in the report. Thus, Members of Congress are less focused on pharma marketing and more focused on food and drug safety, and the proposed new medical device approval process.
Arnold also quotes Kamp’s report, saying that “the best kept secret about healthcare reform is that if it keeps, it’s a pretty good deal for pharma.”
Dec. 1, 2011 — Amidst budget cuts for nearly all other federal programs, the FDA received increased funding for the coming fiscal year, in large part due to “an unusual alliance of consumer advocates and industry groups,” according to a recent blog posting on The Washington Post Web site.
Blogger Dina ElBoghdady writes that the agency’s overall funding in the newly passed agriculture spending bill is up 3 percent from last year’s level of $3.8 billion. Consumer and industry groups pushed for a boost in FDA funding to implement “a landmark food safety bill adopted by a previous Congress.” Funding for that program received $39 million – the largest portion of the increased funding.
The Nov. 30 posting outlines how food groups and consumers came together to further mutual goals and demonstrates the importance of alliances between regulated industry and the public it serves. The Coalition for Healthcare Communication is an active member of the Alliance for a Better FDA, the group that coordinated the funding support effort.
“While we reserve the right to quibble around the edges, adequate funding for FDA is essential for every U.S. citizen and every industry it regulates,” said Coalition Executive Director John Kamp.
To view the full blog entry, go to: http://www.washingtonpost.com/business/economy/fda-funding-boosted-through-lobbying-effort/2011/11/23/gIQAXHQ6CO_story.html
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.
Nov. 22, 2011 – Stating that “a robust dialogue” between pharmaceutical companies and the public “would be seriously chilled” if the U.S. Court of Appeals for the Ninth Circuit upholds the 2009 criminal conviction of former InterMune CEO W. Scott Harkonen for allegedly making false statements about Actimmune in a press release, the Pharmaceutical Research and Manufacturers of America (PhRMA) recently filed an amicus or “friend of the court” brief in support of Harkonen’s appeal.
“The Coalition welcomes PhRMA’s participation in this case,” said Coalition for Healthcare Communication Executive Director John Kamp. “The PhRMA brief demonstrates widespread industry support for forcing federal and state law enforcers to recognize the value of industry communication in managing patient health and the power of the recent Supreme Court decision in Sorrell v. IMS Health to defend against these cases.”
The PhRMA brief asserts: “This case concerns an unprecedented prosecution of a pharmaceutical executive for expressing in a press release his scientific opinion about the development of a drug to treat disease. An affirmance of the decision … would threaten core First Amendment principles by establishing that scientific debate over how to interpret data can constitute a crime.”
PhRMA’s brief calls out the following points:
- The press release in question was not a misstatement of objectively verifiable fact, a trigger for criminal liability;
- The trial court unconstitutionally permitted the jury to find that the press release was false “not because no reasonable scientist could have reached the conclusion drawn, but because some scientists, mainly those of the [Food and Drug Administration (FDA)], disagreed with that conclusion”;
- The trial court’s approach violated the First Amendment because a person “may not be convicted for fraud based upon speech about scientific matters unless the level of scientific consensus is such that no reasonable expert could find the defendant’s statement to be true.”
The amicus brief reiterates the Supreme Court decision in Sorrell, which “confirmed that pharmaceutical manufacturers’ communications with doctors about the safety and efficacy of drugs fall within the First Amendment ambit.” PhRMA then states that “the courts should be particularly leery of a government’s attempt to criminalize speech concerning ‘the effectiveness of [a] particular method of treatment of disease.’”
“Sponsor companies have the best information available on the safe and effective use of their drugs,” according to the Coalition’s Kamp. “Systematically eliminating their participation in discussions with healthcare professionals harms patients. It’s time for government to rationalize these rules in court.”
In addition to the Harkonen appeal, other cases that the Sorrell decision may impact in the near future include:
- U.S. v. Caronia appeal: Alfred Caronia claims that FDA’s limitations on speech regarding off-label uses violated the First Amendment. The U.S. Court of Appeals for the Second Circuit requested additional information following the Supreme Court’s Sorrell decision.
- Par Pharmaceutical Inc. v. FDA: Par seeks to preserve its First Amendment right to provide truthful information to physicians and other healthcare providers about off-label uses. The case, filed with the U.S. Court of Appeals for the District of Columbia Circuit, calls into question the FDA’s authority to censor truthful speech by drug sponsors.
- An appeal by three former Purdue Pharma executives who pled guilty to misbranding charges regarding off-label marketing, is slated to be heard Dec. 6 by the U.S. Court of Appeals for the District of Columbia Circuit. The former Purdue executives are appealing their exclusion from federal health care programs.
“There is no doubt that Sorrell empowered companies and industry advocacy groups to question the government’s authority when it attempts to chip away at the protections afforded speech by the First Amendment,” Kamp said. “We applaud PhRMA for getting involved.”
By Jack E. Angel, Education Foundation Executive Director, Coalition for Healthcare Communication
Nov. 14, 2011 — In response to Opioid prescription drug misuse in this country, the FDA recently released a draft “blueprint” on the basic elements to be included in REMS (Risk Evaluation and Mitigation Strategies) educational programs required of the manufacturers by the FDA.
The guidelines set forth “core messages” intended for use by CME (continuing medical education) providers to develop educational materials for prescribers of long-acting and extended-use opioids. This Blueprint for Prescriber CME is a good foundation for what the FDA wants to accomplish, but raises questions that need to be addressed by the CME community.
In describing how CME providers “will conduct prescriber education” in a Nov. 7 Federal Register notice, the agency stated the following:
“The REMS notification letter expressed FDA’s expectation that the training would be conducted by accredited, independent continuing education providers. FDA later elaborated on its vision for prescriber education stating that we expect the CE training to be provided without cost to the healthcare professionals and that sponsors would offer unrestricted grants to accredited CE providers to develop CE for the appropriate prescriber groups.”
The concern on the part of the CME community is whether the regulated industry’s involvement in the process violates the basic tenets of certified CME. Although the new guidelines likely will generate greater commercial support for certified CME, many in the CME community are fearful of undermining the independence of certified CME providers, a significant industry self-regulation advance over the past decade.
The Coalition for Healthcare Communication strongly supports the provider independence principles. Moreover, it also is dedicated to the thesis that truthful education and industry communication contribute greatly to more effective and efficient healthcare delivery. Industry collaboration is key to advancing patient care through education of doctors and other healthcare professionals.
So, the question here is how do we support these principles while helping to address a pressing national emergency? It seems to make sense for the stakeholders to put their heads together to figure out a way to assist the government by utilizing information, talents, and resources that it may not have. In our view, everyone wins with this effort.
The government is seeking comment on this blueprint and the Coalition intends to weigh in. What do you think? Let us know.
Nov. 8, 2011 — The Association of Medical Media (AMM), a Coalition for Healthcare Communication member organization dedicated to educating and promoting the value of medical publishing and communications, will be holding a meeting next week for AMM members and media agency professionals to discuss the current and future state of digital health communications.
The Nov. 17 meeting, which will be held in New York City, will be moderated by Mark Bard of the Digital Health Coalition. Bard is the co-founder and former CEO of Manhattan Research. Together with his Manhattan Research co-founder Joe Farris, he established the Digital Health Coalition to engage regulatory agencies and the news media in the dialogue about regulation of drug and device companies’ digital marketing efforts.
“The industry, not the FDA, must set the standards and best practices for medical information on the Internet. This project by the Digital Health Coalition promises to advance and improve the medical information available on the Internet,” according to John Kamp, Executive Director of the Coalition for Healthcare Communication. Kamp is a member of the Senior Advisory Board of the Digital Health Coalition and is participating in the development of its programs and projects.
The session, entitled “Insights, Opportunities and Trends from the Future of Digital Health,” will provide an update on efforts underway by the Digital Health Coalition. The session will cover trends in social media adoption and regulation, as well as mobile health. Advertising agency personnel are welcome to attend at no charge.
For more information about the meeting and to register, go to: http://www.ammonline.org/november-2011-event
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.