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 email@example.com. 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