United States v. Caronia: Some Preliminary Thoughts on the Second Circuit’s Decision Invalidating the Ban on Off-Label Promotion
Filed under: Advertising & Lobbying, Health Law, Pharma
Earlier this week, the Second Circuit Court of Appeals at last issued its decision in United States v. Caronia and it is momentous (and predicted to be heading to the Supreme Court). A two-judge majority of the Circuit Court held that Alfred Caronia, a pharmaceutical sales representative, “was convicted for his speech – for promoting [the central nervous system depressant Xyrem] for an off-label use – in violation of his right of free speech under the First Amendment.”
The majority’s decision begins with a threshold question. Was Caronia convicted for conspiracy to misbrand Xyrem because he engaged in off-label promotion qua off-label promotion, that is, for his speech? Or, was his speech simply “evidence that the ‘off-label uses were intended ones for which Xyrem’s labeling failed to provide [the required] directions[,]” as the government argued on appeal? The former would implicate the First Amendment, but the latter would not. The Supreme Court has held that “[t]he First Amendment … does not prohibit the evidentiary use of speech to establish the elements of a crime or to prove motive or intent.” As the Caronia dissent (colorfully) explained, “Abby and Martha [do not have] a First Amendent right to offer arsenic-laced wine to lonely old bachelors with the intent that they drink it. … And any statements Abby or Martha made suggesting their intent—even if all of the statements were truthful and not misleading—would not be barred from evidence by the First Amendment…”
The majority found that Caronia was convicted for his speech alone, pointing to the lower court’s instructions to the jury and to a number of statements that the government made at trial including “[Caronia] conspired through some act of misbranding, and that act of misbranding … was the promotion on October 26th and November 2nd[,] marketing [a] drug for unapproved uses.” Caronia’s conviction must therefore be vacated, the majority concluded. The Food Drug and Cosmetic Act does not “criminaliz[e] the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.” The majority did not disagree with the general proposition that speech may be used as evidence of intent, and it expressly declined to decide the specific question whether the FDCA violates the First Amendment by “defin[ing] misbranding in terms of whether a drug’s labeling is adequate for its intended use, and permit[ting] the government to prove intended use by reference to promotional statements made by drug manufacturers or their representatives.” Even if the Second Circuit’s decision stands, then, the government may be able to argue that Caronia is a case about an erroneous jury instruction with limited practical effect
The majority went on to hold that a ban on off-label promotion qua off-label promotion—like the Vermont law barring drug companies from using physician-specific prescribing data to craft physician-specific sales pitches at issue in the Supreme Court’s 2011 decision in Sorrell v. IMS Health (which I discussed on this blog here)—is unconstitutional regardless of whether strict or intermediate scrutiny applies. The majority gave short shrift (no shrift, really) to the argument that the ban on off-label promotion is necessary to preserve the integrity of the FDA’s drug approval process, suggesting that the government could “minimize … manufacturer evasion of the approval process” by imposing “ceilings or caps on off-label prescriptions.”
The majority did not elaborate on how ceilings or caps on off-label prescriptions would work, on the grounds that the First Amendment puts the burden on the government to demonstrate that they would not. Here, too, there may be an opening for the government, to make a stronger case to the Supreme Court than it did before the Second Circuit (in its briefs or at oral argument) that ceilings or caps would not be “administrable, feasible, or otherwise effective” and that the ban on off-label promotion therefore provides a direct, narrowly-tailored, and crucial incentive to clinical research into already-approved drugs. As the dissent suggested, “[a] ceiling on off-label prescriptions would require collecting data from countless numbers of doctors and patients and, given the medical uncertainties involved, could needlessly (and simultaneously) result in the denial of some effective treatments and the overprescription of ineffective and even dangerous ones.”
Filed under: Advertising & Lobbying, Drugs & Medical Devices, Pharma
In Case you missed it: Research Fellow & Lecturer in Law, Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, Kate Greenwood, on American Law Journal TV regarding Pharmaceutical Off-Label Marketing and Free Speech. A regular blogger here at HRW, Kate Greenwood appeared along with attorneys Hope Freiwald of Dechert, LLP and Brian J. McCormick, Jr., of Sheller, P.C.
Filed under: Advertising & Lobbying, Proposed Legislation
Christmas has just passed and Hannukah now draws to its candled conclusion as Kwaanza begins, heralding the start of a brand new year. These times naturally encourage reflection, and with my twenty-year old prodigal daughter, Lexi, about to return to Occupy D.C. after a holiday respite, I find myself considering the positions of her compatriots who think, foremost, that the influence of big money should be removed from politics–they are championing a constitutional amendment to do so, and there are close to 300,000 signatures petitioning as a prelude to such change. It’s an ambitious and interesting thought this– what would the political landscape look like if legislators and executives voted their conscience without having to calculate the impact upon scores of their largest benefactors? What would health reform look like?
Of the Maine Clean Election Act, Matthew Edge of the Occupy Albany Political Strategy Working Group told Lehrer that “It allows for everyone running for office to essentially have the same amount of money to run. So they can win based on their ideas, and not based on just how much money they can raise. And once they’re elected, since agreeing to opt into the public funding system, the clean elections system requires them to agree not to accept any private contributions. So that seems to be — while it’s not the end all, be all — the first step.”
The Maine Clean Election Act? This is how the Act is described by the State of Maine at http://www.maine.gov/ethics/mcea/index.htm
The Maine Clean Election Act (MCEA) established a voluntary program of full public financing of political campaigns for candidates running for Governor, State Senator, and State Representative. Maine voters passed the MCEA as a citizen initiative in 1996. Candidates who choose to participate may accept very limited private contributions at the beginning of their campaigns (seed money contributions). To become eligible, candidates must demonstrate community support through collecting a minimum number of checks or money orders of $5 more made payable to the Maine Clean Election Fund (qualifying contributions). After a candidate begins to receive MCEA funds from the State, he or she cannot accept private contributions, and almost all goods and services received must be paid for with MCEA funds.
It is, notably, a voluntary program–though participation has markedly increased since the Act’s inception: legislative candidates in the year 2000 totaled 33% (116 of 350); in 2006 & 2008 that number rose to 81% (313 of 386 and 303 of 373 respectively); and in 2010 the number leveled out to 77% (295 of 385). Participation by state senate candidates is even higher, and interestingly, the participation rate of incumbents is high as well–even for those who had won in close races the previous cycle.
Equal money? Consider this from OpenSecrets.org about the 2008 elections:
In 93 percent of House of Representatives races and 94 percent of Senate races that had been decided by mid-day Nov. 5, the candidate who spent the most money ended up winning, according to a post-election analysis by the nonpartisan Center for Responsive Politics. The findings are based on candidates’ spending through Oct. 15, as reported to the Federal Election Commission.
Continuing a trend seen election cycle after election cycle, the biggest spender was victorious in 397 of 426 decided House races and 30 of 32 settled Senate races. On Election Day 2006, top spenders won 94 percent of House races and 73 percent of Senate races. In 2004, 98 percent of House seats went to the biggest spender, as did 88 percent of Senate seats.
But of course, as the Maine Ethics Commission responsible for overseeing the MCEA has recently noted,
In June 2011, the U.S. Supreme Court ruled in Arizona Free Enterprise Club’s Freedom Club PAC v. Bennett that the way Arizona awarded matching funds to candidates was unconstitutional. The Court’s decision upheld the constitutionality of publically funded campaigns but ruled that the “triggering” of matching funds based on the spending by other candidates or independent spenders was a violation of the First Amendment. Maine, like Arizona, has a full public funding program for candidates; therefore, the Supreme Court’s decision had an impact on Maine’s MCEA program.
A retooling is said to be underway for the MCEA. As it stands, matching funds have been jettisoned. According to the Maine Commission: “The loss of matching funds presents a challenge for the program. In the last four election cycles, 40% – 50% of legislative MCEA candidates received some matching funds. However, the core function of the program remains unchanged.”
Given the reality of an electorate system in which money seems to almost guarantee office, coupled with the strictures of Arizona Free Enterprise Club’s Freedom Club and Citizens United– is calling for a constitutional amendment outlandish?
Filed under: Advertising & Lobbying, Pharma, Prescription Drugs
Last spring, the Food and Drug Administration (FDA) launched the Truthful Prescription Drug Advertising and Promotion Program (known more accessibly as the “Bad Ad Program“). The goal of the program is to enlist the help of health care professionals, consumers, and industry representatives in noting FDA violations and reporting activities and messages that are false or misleading. Common drug marketing violations include omitting or downplaying risk, overstating effectiveness, promoting off-label uses and making misleading drug comparisons. The program is run by the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), which is responsible for “ensuring truthful advertising and promotion of prescription drugs.”
The FDA published a year-end report in May noting that the program has been successful in raising awareness. DDMAC received 328 reports of potentially untruthful or misleading promotions in one year, with the majority of those submitted by health care professionals (188 reports) and consumers (116 reports). The report notes that prior to the Bad Ad program, the FDA received an average of about 104 reports per year.
And the Bad Ad tips are still coming in. Just at the end of last month, DDMAC issued a reprimand letter to Pfizer’s Vice President of US Regulatory Affairs regarding misleading advertising of drugs on the company’s Lipitor website. A complaint to the Bad Ad program observed that the links from the Lipitor site led to pages for the drugs Caduet (for high cholesterol and blood pressure), Norvasc (for high blood pressure), and Chantix (for smoking cessation). But each of those pages failed to note any of the risk information associated with the drugs, which is a violation of the Federal Food, Drug, and Cosmetic Act.
The FDA states that “by omitting the most serious and frequently occurring risks associated with Caduet, Chantix, and Norvasc, the webpage misleadingly suggests that these drugs are safer than have been demonstrated.” The letter ends with a request that Pfizer immediately stop the dissemination of violative promotional materials for the drugs. The company was to have submitted a written response to the complaint by September 14th that states how they will comply with the request.
While the Bad Ad program may be working to raise awareness among health professionals and consumers, one violation may not be enough to induce compliance from pharmaceutical companies. In fact, DDMAC already chided Pfizer in March of 2009 for omitting risk information for Caduet and Chantix. In that case, Pfizer sponsored links for the drugs on Internet search engines. The sites linked to did not mention any risk information and therefore, presumably, can be said to have also represented the products in a manner which, as above, suggests that these drugs are safer than have been demonstrated.” The most recent letter states that “DDMAC is concerned that Pfizer is continuing to promote its products in a similarly violative manner.” A citizen’s task force is a good way for the FDA to multiply their eyes and ears to keep tabs on misleading and/or violative advertisement. We’ll see what further successes the next year-end report for the Bad Ad program can show. Or, perhaps, success might also be measured in the absence of violations.
Last month, the Food and Drug Administration (FDA) released new regulations for sunscreen manufacturers to update rules from over 30 years ago. The new regulations, which will take effect in 2012, require that sunscreen manufacturers prove certain labeling claims before they can be used on packaging. In an effort to avoid consumer confusion, the FDA is regulating when sunscreens can claim broad-spectrum protection or water resistance and is also setting a sun protection factor (SPF) cap at 50.
According to the new rules, only sunscreens that block both ultraviolet A (UVA) and ultraviolet B (UVB) rays can be labeled to have broad spectrum protection. While UVB rays are the primary cause of sunburn, UVA rays contribute to skin cancer risk and premature aging. Sunscreens that are not broad spectrum or with SPF values less than 15 will be given the following warning label:
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
In addition, sunscreens can no longer be labeled as waterproof or sweatproof, and manufacturers cannot use the term “sunblock” on their packaging. The FDA remains concerned with exaggerated claims, as no sunscreen can block the sun entirely, nor are any of them completely waterproof. Instead, sunscreens can be called “water resistant” and must be marked as either 40 or 80 minutes, depending on how long the SPF protection will last. Finally, the FDA is requiring any sunscreens with rates above SPF 50 be labeled as “SPF 50+”, given that data suggest no additional protection above that level.
In issuing these new regulations, the FDA is targeting rising skin cancer rates among Americans. The Centers for Disease Control and Prevention (CDC) reports that skin cancer is the most common form of cancer in the United States with 58,000 new cases diagnosed and around 8,000 deaths per year. The hope is that the new regulations will make it easier for consumers to choose the best sun protection and that this will help decrease the incidence of skin cancer.
As welcome as these new regulations are, they are subject to two major criticisms. The first is that the amount of sunscreen used by manufacturers to determine SPF values is not consistent with actual use by consumers. In testing, two milligrams of lotion are used for every square centimeter of skin. Scientific American reports that most people use only one fifth to one half of that quantity, meaning that their skin is not fully protected at the labeled SPF level. Secondly, the FDA assumes for designation purposes that consumers will always follow the directions on their sunscreen products. In practice, sunscreen users fail to reapply as often as directed (which is at least every two hours during sun exposure).
Even with these limitations, the new system is a marked improvement to the 1978 regulations. Consumers can protect themselves even before the new regulations take effect in 2012– the FDA recommends that individuals use sunscreen with an SPF of at least 15 and a broad spectrum rating to protect from the full range of sunlight. In addition to purchasing the right sunscreen products and following directions, the FDA encourages that people wear proper clothing and limit sun exposure to help protect skin from UV rays.