FDA’s ‘Bad Ad’ Program is in Full Effect

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 14^th 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.

Sunscreen Labeling Rules Revamped

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.

The Junk Food Marketing Debate: A First Amendment Right or Just Making Sure Kids Aren’t What They Eat?

Remember the Omnibus Appropriations Act of 2009 (H.R. 1105) that President Obama signed on March 11, 2009?   No?  Good, me neither, but my excuse is that I was busy applying to law schools.  If you and I had been paying closer/any (take your pick) attention, we would have seen that the Act included, among other things, a provision calling for the Federal Trade Commission, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Department of Agriculture to create an Interagency Working Group on Marketed Food to Children (”Working Group”) composed of representatives from each agency.  The Working Group would research and recommend standards for the marketing and advertising of food to children age 17 years and younger.   These recommendations would be presented to Congress down the road.

Well, a couple of years passed, but in April 2011 the Working Group released its 26-page “Preliminary Proposed Nutrition Principles to Guide Industry Self-Regulatory Efforts” for public comment (which you can submit by clicking here before July 14). The Working Group notes that

… in the FTC’s 2008 study on Marketing Food to Children and Adolescents, three food categories — breakfast cereal, restaurant foods, and snack foods — represented approximately 70% of food marketing expenditures directed to children under 12. Similarly, three categories of foods — carbonated beverages, restaurant foods, and non-carbonated beverages — represented 69% of the food marketing expenditures for adolescents ages 12-17 year….  [Overall] [t]he categories most heavily marketed to children and adolescents, ages 2 -17 years are: breakfast cereals; snack foods; candy; dairy products; baked goods; carbonated beverages; fruit juice and non-carbonated beverages; prepared foods and meals; frozen and chilled deserts; and restaurant foods. The Working Group is therefore recommending that the food industry focus its efforts on ensuring that any advertising or marketing of food products within these ten categories meet the nutrition principles set out below. (Emphasis added.)

The Working Group focuses on two nutritional principles “that both improve the nutritional quality of foods marketed to children and can be feasibly implemented by industry with sufficient time to accomplish reformulation,” namely, “Meaningful Contribution to a Healthful Diet” (Principle A)  and “Nutrients with Negative Impact on Health or Weight”  (Principle B).  Principle A ensures that foods marketed to children contain two or more of the following food groups: “fruit, vegetable, whole grain, fat-free or low-fat milk products, fish, extra lean meat or poultry, eggs, nuts and seeds, or beans.”  Principle B ensures that foods marketed to children have limited amounts of saturated fat, trans fat, sodium, and added sugars.  The Working Group makes sure to point out (several times in fact) that its recommendation are based on the 2010 Dietary Guidelines for Americans.

Really, this all sounds quite sensible, if not a little over-protective… but considering, as The Washington Post has reported, that Type 2 diabetes has significantly increased among people age 20 years and younger, what else can this country do to curb obesity and poor eating habits?  Even if we could reduce the cost of nutrient-rich and quality foods so that everyone could afford them, how do we neutralize the marketing of junk food to children?  In a report last month, NPR noted how

[the Working Group] broke from the past by seeking to include 12- to 17-year-olds in its guidelines. Traditionally, limits on marketing focused on the very young. But the government sought to expand them to older children, in part because they are heavy consumers of social media, cell phone messages and online games — the new frontier for ads.

That new frontier of advertising to children through online games — also known as “advergaming” (forgive my use of Wikipedia but Merriam-Webster doesn’t list the word) — includes Asylum 626 and Hotel 626, two advergames sponsored by Doritos.  As NPR reported,

“[w]hat we’re talking about are very complicated and very subtle forms of marketing that aren’t always clear as such,” says Kathryn Montgomery, a professor of communications at American University and an advocate for limiting food ads to teens.

[...]

Montgomery says such ads work subliminally and use friends to influence other friends.

But efforts to restrict ads to teens draw lots of opposition from the food and advertising industries. The industries say the overlap between teen and adult audiences makes the proposed restrictions impractical.

Critics, including the U.S. Chamber of Commerce, have questioned the constitutionality and logic of the Working Group’s nutritional proposals.  The Hill’s Healthwatch has reported that some critics see a First Amendment issue because

“[w]hat they’re doing is trying to simultaneously … suppress speech, while insulating it from judicial review,” said Northwestern law Professor Martin Redish, one of the panelists at a Chamber of Commerce discussion Thursday. “Because if these regulations were truly just advisory, there would be no case or controversy.”

[...]

“Industry’s rights are being violated here,” Redish said, “but there’s something deeper and darker that’s going on: The government is treating us like sheep.”

While constrained to commercial speech, Redish said that attitude has broader implications. People, he said, “can’t be sheep in the commercial realm and then all of a sudden, in the political realm, they’re free-thinking adults who can make basic choices.”

NPR has reported that other critics question the logic behind the proposal and the implicated age range.

Elaine Kolish directs an industry-funded program called the Children’s Food and Beverage Advertising Initiative. For the past five years this initiative sponsored its own voluntary standards that focus only on the 12-and-under set.

“You know, we let kids drive and we let them hold jobs when they’re 16. They can get married in some states, and they can join the military with permission, and they can be held criminally responsible for their actions in a number of situations,” she says. “So I think that the notion that you’d have to have nutrition standards that say you can’t let a kid see an ad for a french fry but you can let them join the military doesn’t really make a lot of sense.”

So where do we go from here?  Is industry self-regulation the answer to making products that better fit on MyPlate?  As I’ve noted in a previous post about McDonald’s Happy Meal toys, sometimes the answer can be stricter parenting (just say “no”).  Yet how can parents instill and maintain healthy eating habits in their kids when advertisements for unhealthy food bombard them through television, social media, and online games?

Functional Foods: What Happens When Advertising Misleads Consumers?

An article recently published in the New York Times focuses on the complexities of modern-day food labeling. It seems that almost every product in the grocery store touts a label boasting of some health benefits, from supporting heart health to lowering cholesterol levels. These items are referred to as functional foods or nutraceuticals, and they are foods that claim to provide health benefits beyond the traditional nutrients they contain. Functional foods are one of the fastest growing areas in the food industry.

While companies cannot claim that functional foods actually prevent or cure diseases, they can market foods with having health-promoting or wellness-maintaining properties. The article explains how economists refer to items like functional foods as credence goods. For these foods, most consumers are unable to assess the utility of health claims and therefore rely on advertisements to be true. Misleading marketing and advertising can leave consumers confused about what they are buying and about just how helpful some products are in maintaining overall health.

The Federal Trade Commission (FTC) oversees food advertising and has filed recent complaints of deceptive marketing against Kellogg and Dannon. Frosted Mini-Wheats can no longer claim that they are clinically shown to improve children’s attentiveness by nearly 20 percent, and boxes of Rice Krispies are no longer emblazoned with a claim that they support children’s immunity. Dannon was forced to remove claims that its Activia yogurt improves intestinal transit time, as the FTC found no scientific proof for such a claim.

The Food and Drug Administration (FDA), which oversees food labeling, has also noted the problems with false or misleading claims on functional foods. Commissioner Margaret Hamburg wrote an open letter to the industry urging them to examine product labels to avoid violating established labeling standards. But the issue seems too complicated for an open letter to solve. As the FDA’s deputy commissioner for foods Michael Taylor wrote last year,

“Going after [misleading marketers] one-by-one with the legal and resource restraints we work under is a little like playing Whac-a-Mole, with one hand tied behind your back.”

The Deputy Commissioner appears to be right, and not all food companies are willing to give up false or misleading claims or labeling without a fight. In 2010, the FDA found that the makers of POM Wonderful pomegranate juice had violated the Federal Food, Drug, and Cosmetic Act by making therapeutic claims that “establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.” When POM did not retract its claims, the FTC filed a complaint against the maker for deceptive advertising based on unsubstantiated scientific claims. POM was initially defiant (calling the FTC complaint unwarranted), but eventually settled and changed their advertising.

The company did, however, file a federal lawsuit against the FTC for acting outside its authority and violating the right to free commercial speech. As NYU Professor Marion Nestle pointed out in an article, POM’s suit is being brought “not because they are claiming they have science on their side, but because they think their health claims, believable or not, are protected by the First Amendment.”

There are other ways to confront misleading ‘healthy’ claims before they are printed on products and sold to consumers. The article notes the approach of the European Food Safety Authority, an independent panel of experts to whom food makers submit applications of scientific evidence backing their desired claims. The panel reviews each case and issues an opinion on the evidence, and will create a list of approved health claims for companies to use in the future.

The FDA’s approach is focused on the other end of the product line, and encourages consumers to learn to read nutrition labels and make wise purchasing decisions. This includes updating the Nutrition Facts Panel printed on the back of food packages, adding calorie counts to restaurant menus, and pushing the Let’s Move initiative to combat childhood obesity. A smarter consumer is an admirable and essential goal, but with the amount of money put into advertising on a global scale, the FDA must issue stricter guidelines for food companies. Hopefully, the outcome of the POM lawsuit will help empower the FDA to do just that.

Survivors’ Costs Gone Wild, Beverage Tax Edition

Gradgrind is alive and well, as this exchange on soda taxes explains:

This discussion between Greg Mankiw and David Leonhardt reads a bit like an economics textbook gone rogue. At issue is whether a soda tax makes sense. David Leonhardt says it does: There’s good evidence that it will reduce obesity, which will reduce health-care costs. Au contraire, says Mankiw: You have to “net out the appropriate budgetary savings from shorter lifespans.” In other words, maybe it’s not worth it, as the obese live shorter lives and so cost the government less.

Ezra Klein goes on to describe how the calculation of survivors’ costs (without offsetting valuation of survival benefits) “disadvantages the quality/value agenda as compared with the cost-control agenda.”

I would add a couple more points to complicate the analysis:

First, Mankiw may be interested in exploring the benefits of the “plus-size” clothing market. As the NYT reports, “The plus-size market increased 1.4 percent while overall women’s apparel declined 0.8 percent in the 12 months leading up to April 2010 versus the same period a year earlier, the most recent figures available, according to NPD Group, a market research firm.” Certainly taxes that discourage the development of this growth industry should be scrutinized carefully.

Second, for team Leonhardt, we might think of the tax as a way of deterring anti-beverage tax ads which have glutted the tri-state airways over the past few months. We could all do with a little less of the rent-seeking featured below:

Comment on Medicare Advantage and Prescription Drug Benefit Programs: Final Marketing Provisions (Parts III & IV)

[Ed. Note: This post is a continuation of a post we published the other day regarding "modifications and additions to initial marketing regulations implementing The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ("MMA"), which "established the Medicare Prescription Drug Benefit Program (Part D) and made revisions to [] provisions” of the Medicare Advantage Program.” The initial post, detailing the modifications, can be found here.]

By Michael Rabasca

PART III

The strongest argument against these final regulations is that they prevent eligible enrollees “from learning about their full range of healthcare options” and, thus, unduly hinder the market for Part C and Part D plans. (Federal Register, Volume 73, No. 182 at p. 54214). In order for consumers to make informed healthcare decisions, they need to have ready access to information. Marketing is all about the strategic distribution of information, and placing restrictions on plan marketing activities limits the information available to potential enrollees. Thus, regulating the marketing activities of Part C and Part D plans could lead to consumer ignorance and severely limit the choices of Medicare eligible individuals.

These new rules significantly hinder the ability of potential Part C and Part D plan participants to both obtain plan information and enroll in plans. Many individuals who are eligible for Medicare are hospitalized or living in nursing homes where healthcare is delivered. Under these rules, Part C and Part D plans would be unable to make marketing presentations, distribute enrollments applications, or collect completed applications from these individuals. Unfortunately, these potential enrollees are often the people who would benefit the most from enrolling in these plans and these regulations severely limit their ability to do so.

PART IV

I think that government oversight of Part C and Part D plans’ marketing activities provides vital protection to the individuals who are eligible to participate in these plans. I feel that Medicare participants are particularly vulnerable to questionable marketing practices, and these final regulations provide important modifications and additions and to CMS’s marketing regulatory scheme. Nevertheless, I am not convinced that these rules do enough to deter Part C and Part D plans from engaging in impermissible marketing activities. Although CMS may impose civil monetary penalties or marketing/ enrollment sanctions on plans that violate its marketing regulations, these penalties are merely discretionary. I agree with one commenter who suggested that CMS should mandate civil monetary penalties for plans that violate the marketing rules in order to ensure that violators are punished. (Federal Register, Volume 73, No. 182 at p. 54211). Additionally, I feel that CMS should provide some sort of financial incentive for both individuals and competing plans who report marketing violations in order to increase the likelihood that violations are discovered and reported. These additional enforcement tools would help to ensure that the new final marketing regulations serve their purpose by effectively protecting individuals who are eligible to participate in Part C and Part D plans from inappropriate marketing tactics.

Comment on Medicare Advantage and Prescription Drug Benefit Programs: Final Marketing Provisions (Parts I & II)

By Michael Rabasca

Part I

These rules represent modifications and additions to initial marketing regulations implementing The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (”MMA”), which “established the Medicare Prescription Drug Benefit Program (Part D) and made revisions to [] provisions” of the Medicare Advantage Program (Part C). (Federal Register, Volume 73, No. 182 at p. 54208). The Centers for Medicare and Medicaid Services’ (”CMS”) enacted these final regulations pursuant to §§ 1851(h) and 1860D-1(b)(1)(B)(vi) of the Social Security Act, which empower the CMS to “implement standards consistent with ‘fair marketing.’” (Federal Register, Volume 73, No. 182 at p. 54210).

The most significant aspect of these final regulations is the new restrictions they place on Part C and Part D plans’ marketing activities. Specifically, these rules prohibit the following:

(1) unsolicited direct contact with potential enrollees, including telemarketing (42 C.F.R. §§ 422.2268(d), 423.2268(d));

(2) selling non-healthcare related products during a plan marketing event or presentation (42 C.F.R. §§ 422.2268(f), 423.2268(f));

(3) conducting marketing presentations or distributing and/or collecting enrollment applications “in provider offices or other areas where healthcare is delivered to individuals, except . . . where such activities are conducted in common areas in healthcare settings” (42 C.F.R. §§ 422.2268(k), 423.2268(k));

(4) conducting marketing presentations or distributing and/or collecting enrollment applications at “educational events”  (42 C.F.R. §§ 422.2268(l), 423.2268(l)); and

(5) offering meals to potential plan enrollees at marketing events (42 C.F.R. §§ 422.2268(p), 423.2268(p)).

These regulations also implement new rules regarding CMS’s procedure for reviewing Part C and Part D plan marketing materials. Generally, Part C and Part D plans must submit all marketing materials to CMS at least forty-five days before distribution. (42 C.F.R. §§ 422.2262(a), 423.2262(a)). However, the regulations provide for an abbreviated “file and use” procedure, under which CMS deems certain materials approved five days after submission. (Federal Register, Volume 73, No. 182 at p. 5410). Previously, Part C plans could use the “file and use” procedure to obtain approval of marketing materials if: 1) the plan had a record of continued exemplary performance in CMS reviews of its marketing materials; or 2) the plan certified that the marketing materials in question did not contain “substantive content” or, alternatively, only used “model language already reviewed and approved by CMS.” (Federal Register, Volume 73, No. 182 at p. 54210).  Part D plans, on the other hand, could only obtain “file and use” approval through plan certification. (Federal Register, Volume 73, No. 182 at p. 54210). However, these final regulations “eliminate file and use status based on an organization’s track record” for Part C plans, and implement “a uniform policy of applying the file an use policy to marketing materials that either use model language without substantive modification, or materials identified by CMS as not containing substantive content warranting CMS review” for both Part C and Part D plans. (Federal Register, Volume 73, No. 182 at p. 54210-54211).

Additionally, these final regulations implement licensure requirements for plan marketing representatives. Specifically, the rules require Part C and Part D plans to exclusively use State licensed marketing representatives to conduct direct marketing activities targeted at potential plan enrollees. (42 C.F.R. §§ 422.2272(c), 423.2272(c)). Plans must also notify states that they are using licensed representatives in a manner that is “consistent with the appointment process provided for under State law.” (42 C.F.R. §§ 422.2272(c), 423.2272(c)).

Finally, these rules mandate that Part C and Part D plans make certain disclosures to plan participants. Under these final regualtions, plans must now disclose the information specified in §§ 422.111(b) and 423.128(b) to all plan participants both “[a]t the time of enrollment and at least annually thereafter, 15 days before the annual coordinated election period.” (42 C.F.R. §§ 422.111(a)(3), 423.128(a)(3)).

PART II

The best argument in support of these final regulations is that they provide necessary consumer protections. Generally, individuals age sixty-five and older, and people with disabilities are eligible for Medicare programs. This group of potential enrollees is particularly vulnerable to dubious marketing tactics. Allowing insurers to market their Part C and Part D plans unchecked could be harmful potential participants. Indeed, permitting plans to distribute information and solicit enrollment applications at any place and in any manner they chose has the potential to confuse potential enrollees and, in some cases, could result in plans coercing individuals into participating. Thus, a free market philosophy as to plan marketing practices is inappropriate in the Part C and Part D setting, and strict regulation is required.

These new rules protect consumers by: 1) prohibiting certain problematic marketing activities; and 2) limiting the places where plans may conduct marketing activities. Indeed, prohibiting Part C and Part D plans from offering meals or selling non-healthcare related products to potential participants prevents hurried “enrollments without personal attention to the appropriateness of the plan.” (Federal Register, Volume 73, No. 182 at p. 54215). Additionally, prohibiting plans from conducting marketing activities and soliciting enrollments at educational events and anywhere healthcare is delivered prevents plans from targeting individuals for enrollment when they are vulnerable to suggestion, and avoids the appearance that individual providers and facilities recommend or support specific plans.