Aug. 28, 2012 – In a ruling that could set the stage for another U.S. Supreme Court review of First Amendment restrictions on commercial speech by FDA, the U.S. Court of Appeals for the District of Columbia ruled Aug. 24 that the FDA did not adequately support its rules under the First Amendment nor bring forward “substantial evidence” required under the Administrative Procedure Act (APA) to show that mandatory graphic warning labels on cigarette packaging would reduce smoking.
The 2-1 decision upholds a Feb. 29 U.S. District Court for the District of Columbia ruling granting a motion for summary judgment in favor of five tobacco companies who called unconstitutional an FDA rule requiring that new, mandatory graphic images be added to specific textual warnings on cigarette packaging. However, the Aug. 24 ruling is not in accord with a March ruling by a federal appeals court in Cincinnati, which called the 2009 Family Smoking Prevention and Tobacco Control Act constitutional.
“Without denying the need of people to stop smoking, what is very clear from this decision is that the FDA must recognize the First Amendment and the APA when regulating speech,” said Coalition for Healthcare Communication Executive Director John Kamp. “FDA is in dangerous denial about its need to respect the First Amendment. If these tobacco rules are a violation of the First Amendment, how can the FDA possibly defend bans on drug sponsors sharing information with doctors and patients about the life-saving, off-label uses of their products?” he noted.
Specifically, the U.S. Court of Appeals for the District of Columbia weighed in on an FDA proposed rule calling for warning labels that combined graphic images with textual messages and a “1-800-QUIT-NOW” smoking cessation hotline. Citing the Supreme Court’s decision in Sorrell V. IMS Health Inc., the court asserted that even when the government finds expression “too persuasive” it does not have permission “to quiet the speech or to burden its messengers.”
Because the FDA failed to present any data to support the premise that enacting the proposed graphic warnings will accomplish the agency’s goal of reducing smoking rates, the court stated that the rule “cannot pass muster under Central Hudson.”
With this issue creating a disagreement among two appeals courts – D.C. and Cincinnati – it sets up a very likely appeal to the Supreme Court to decide the First Amendment issues raised. How that plays out will have repercussions regarding the FDA’s authority to limit commercial speech for tobacco and other products it regulates.
“Until recently, the FDA has
kept the off-label restriction cases out of the Supreme Court,” Kamp said after the Aug. 24 ruling. “If the Supreme Court rules against FDA on this one, that ‘luck’ is unlikely to last.”
The appeals court states that even if it can be assumed that the marketing efforts of the tobacco companies in this case can be “properly classified as commercial speech, and thus subject to less robust First Amendment protections, a thorny question remains: how much leeway should this Court grant the government when it seeks to compel a product’s manufacturer to convey the state’s subjective – and perhaps ideological – view that consumers should reject this otherwise legal, but disfavored product?”
The images and the hotline name proposed by the FDA “cannot rationally be viewed as pure attempts to convey information to consumers,” the ruling states. “They are unabashed attempts to evoke emotion … and browbeat consumers into quitting.”
The court also holds that the FDA “has not provided a shred of evidence – much less the ‘substantial evidence’ required by the APA – showing that the graphic warnings will ‘directly advance’ its interest in reducing the number of Americans who smoke.” Further, the court found the FDA’s reliance on data
from Canada “underwhelming.”
Aug. 22, 2012 — Sanofi is moving forward with social media efforts for diabetes using its own social media rules in the absence of guidance on the topic from the FDA, according to a Beyond the Pill article discussing a post on Fast Company.
It appears that Sanofi and other companies pursuing social media marketing may have time to experiment with different approaches, as the publication of the document is not imminent. “We are working on the area and
it’s something we feel is important but we don’t
have a specific timeline right now,” Ernest Voyard, senior regulatory council at the FDA’s Office of Prescription Drug Promotion, told Fast Company.
To read the full article, go to: http://beyondthepill.medivo.com/2012/08/sanofi-writing-the-rules-of-social-media/
Aug. 21, 2012 – A recent article posted on Pharmalot.com suggests that pharmaceutical company direct-to-consumer (DTC) spending tells a story about the company’s product
For example, the article states that data released by Cegedim Strategic Data – charting DTC spend by the top 10 pharma companies from July 2011 to April 2012 – demonstrate that Pfizer “boosted its [DTC] spending considerably in the weeks leading to the patent expiration for its best-selling Lipitor cholesterol pill and then, overall, curtailed that spending in subsequent months.”
According to the article, the company spending the most money on DTC advertising during this period was Eli Lilly. “This likely reflects, in part, a need to keep its corporate head above water in the competitive diabetes market,” the Pharmalot article states.
“It is important to watch these developments on DTC measured media, but we need to recognize that they are just estimates, and only estimates of some consumer outreach,” remarked Coalition for Healthcare Communication Executive Director John Kamp. “Moreover, they don’t present a full picture of marketing spend and miss many emerging consumer media.”
Mark Tosh, managing editor, BTP Insights, agreed that reported DTC spending totals do represent a way to gauge the broader DTC advertising market across a period of time, but he told the Coalition that “the numbers should not be viewed as the absolute measure of spending by an individual company or brand.”
Tosh noted that print and even broadcast advertising space is discounted from the rate card, and “there really is no way to accurately calculate these discounts or to know which company (or whose media agency) drives the hardest bargain at the negotiating table.”
Also, there is an area of DTC spending – point-of-care marketing – that passes “mostly under the radar,” he
said. This marketing includes an array of materials available at doctors’ offices and pharmacies, and is a growing segment of the market, according to Tosh.
“So, while it’s interesting to get the ‘best guess’ total on the overall DTC sector, the numbers are likely far from the actual spending reality that companies report internally,” he said.
To read the full Pharmalot article, go to: http://www.pharmalot.com/2012/08/which-drugmaker-spends-how-much-on-dtc/
Aug. 20, 2012 – With the politics of healthcare front and center during the final days leading up to the
2012 Presidential election, the Coalition for Healthcare Communication’s Fall Member Meeting, to be held Sept. 18-19 in Washington, D.C., will feature speakers who know which candidates are running ahead and how they might change the Affordable Care
Act and other health policies once they are in office.
Jennifer Duffy, senior editor of the Cook Report, will kick off the meeting with an election preview, and two veteran health policy advisors – J.D. Kleinke from the American Enterprise Institute and Dr. Kavita Patel from the Brookings Institute – will discuss the future of Washington-directed healthcare programs. Highlights from the Coalition’s meeting will be included in future postings on the Coalition Web site.
For more information on how to join the Coalition, please contact Coalition Executive Director John Kamp at firstname.lastname@example.org.
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By John Kamp
Executive Director, Coalition for Healthcare Communication
Aug. 6, 2012 — When Congress recessed last Thursday we marked nearly the end of this session and began the final stretch of the Congressional and Presidential elections that will affect the next four years of governing. From this point forward we have the all-important
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nominating conventions, only eight more legislative days in September, the elections, and a very important lame-duck session. 2013 will bring us new faces in Congress and perhaps the White House. Here are some of the highlights of what transpired at the end of the session, as well as a look at what might happen next.
PDUFA V: The Five-year FDA Funding & Fees Bill Passes
Congress succeeded in funding the FDA for the next five years with comparatively little drama, fireworks and even political posturing. Sometimes the government works. Most importantly, the legislation did not include any amendments to ban or further restrict marketing and did include one mildly optimistic provision prompting the FDA to complete its social media policies within the next two years. (Presumably, nearly five years from the 2010 hearings will be enough time to complete findings, deliberations and orders. But, you will get no guarantees here.)
Otherwise, the Prescription Drug User Fee Act V (PDUFA V) sets new approval guideposts for pharma applications, extends fee programs to generics and medical devices, and reasonably funds the FDA for the next five years (unless the across-the-board cuts from last year’s failed budget agreement go into effect as scheduled on Jan. 2, 2013). (See note on the Lame Duck session below.)
Health Reform After Supreme Court Decision
The U.S. Supreme Court left most provisions of the Affordable Care Act (ACA) in place. Of particular importance to us, the following provisions remain intact: the Sunshine Act, the FDA mandate to report to Congress on the advisability of creating a “drug facts box,” and the essentials of the PhRMA deal that promised $80-100 billion dollars from pharma in return for closing the Part D “donut hole” and adding up to 38 million newly insured patients to the medicine customer pool.
Although politicians and policy wonks are speculating wildly on how many states may “take advantage” of the freedom to turn back federal money to insure many of those new patients, it seems at least plausible that few states will refuse federal dollars. Understand that under the ACA, federal tax dollars contribute 100 percent of the costs for
the newly insured for the first three years, and then contribute 90 percent of costs in the subsequent years. Meanwhile, expect that 2013 – no matter who wins the elections – will be marked by more tweaks to healthcare reform, presenting more opportunities to upset the PhRMA deal, and to invoke more criticism of pharma prices and our marketing programs.
Lame Ducks, the Fiscal Cliff and Tax Expenditures
While incumbent candidates seem happy to keep the political choices of the post-elections “lame duck” session in the background, Wall Street, Washington wonks, economists and many
others are anxiously awaiting the hard money decisions that must be made to avoid the fiscal cliff created by the Super Committee budget ceiling bust earlier this year. In short, that debt ceiling bill – unless revised – sets in place a series of budget cuts and tax increases economists promise would put the United States firmly back into a recession.
Everyone “Inside the Beltway” seems to understand the stakes, but few are willing to predict how the Congress will respond. Last Thursday, former House Member Vic Fazio (D-Calif.), a longtime friend of the advertising industry, made this observation: “Everyone’s ox will be gored or the compromise will not be good for anyone.” Fazio said he hopes that Congress and the President-elect will rally around the proposals of last year’s Simpson-Bowles Committee (http://www.fiscalcommission.gov/).
These proposals include tax increases and budget cuts virtually no candidate wants to talk about on the campaign trail – tax increases for nearly everyone and spending cuts in defense and virtually every popular program from Social Security to Medicare. Meanwhile, The Advertising Coalition, including the AAAA and the CHC, assumes that every tax expenditure – including the deduction for marketing costs – could be considered in that session and is fully prepared for battle.
Despite some recent luck predicting the outcome of the Supreme Court decision on the ACA, the November elections are just too close to call. Moderates in the battleground states of Florida, Ohio and Virginia, and even in Iowa, Minnesota, Missouri, Pennsylvania, Wisconsin and other often-settled states, will decide the election. Recent polls in many of those states give Obama the edge with moderate voters right now by 4 to 8 percentage points, but similar polls of committed voters (those virtually certain to vote) give Romney a four-point edge.
Regardless, both candidates and their Congressional counterparts have much riding on the political conventions – when many uncommitted voters pay attention and often decide – and both desperately watch the economies of the United States and the European Union, employment numbers, gas prices and every other indicator of consumer/voter sentiment as the election nears. Many say the election will again come down to who is most likable and that Romney, especially, is in need of a Madison Ave. makeover.
So, I will leave it to you and the undecided voters to tell me who will win the Presidential election. Meanwhile, the Congressional prognosticators say that the Republicans likely will retain the House, perhaps losing a few seats, and that the Senate, too, is way too close to call. Many suggest that in the Senate the final seat number will be somewhere between the 52-48 goalposts, and that even a 50-50 split is possible, giving the Vice President a very important deciding vote.
In summary, while the stakes are high for us and the entire country, the political and health policy events will move very quickly over the next several months. Contributing members of the CHC will get a much closer view of these evolving events by participating in the DC meeting on Sept. 18 and 19. Dinner on the 18th will be highlighted by a nonpartisan late look at the elections from a leader from Cook Report. The next morning will start with two diverse views on the government’s role in the future of U.S. healthcare, followed by an interactive session among CHC leaders regarding what our industry must do to survive and thrive amid the imminent changes while doing its part to improve the care of patients and the public health.