Cross-Posted at Bill of Health
At Regulatory Focus earlier this week, Alexander Gaffney wrote about what he characterized as “a torrent of studies” that FDA is conducting or has proposed conducting on prescription drug promotion, and, in particular, on direct-to-consumer advertisements. The studies include, among others, a survey study aimed at sussing out “the influence of DTC advertising in the examination room and on the relationships between healthcare professionals and patients”, a study exploring similarities and differences in the responses of adolescents and their parents to web-based prescription drug advertising, and a study that will use eye tracking technology to collect data on the effect of distracting audio and visuals on participants’ attention to risk information.
Gaffney speculates that “the proposed studies could indicate coming changes in FDA’s regulatory approach toward advertising[.]“ Another possibility is that the studies are part of an effort by FDA to build up the evidence base supporting its current regulatory approach. In a Tweet commenting on Gaffney’s article, Patricia Zettler–a Fellow at Stanford Law School’s Center for Law and the Biosciences who was formerly an Associate Chief Counsel for Drugs at FDA’s Office of Chief Counsel–asks whether the data generated by the studies could help insulate FDA from First Amendment challenges.
Commercial speech is only protected under the First Amendment if it is not false or–perhaps more relevant in the context of direct-to-consumer advertising–misleading. In Christopher Robertson’s recent essay in the Boston University Law Review, he argues that when the truth about a claim is known, as it likely the case with an on-label direct-to-consumer advertisement, it is sensible to put the burden on the government to “prov[e] that the true speech is misleading…given the epistemic value of truth and our aversion to paternalism, especially as a motivation for speech regulation.”
As I discussed previously here, courts called upon to decide whether an advertisement or form of advertising is true, false, or misleading are permitted “to look to the facts to determine ‘the actual effect speech will have.’” In Florida Bar v. Went for It, for example, the Supreme Court relied on the government’s “106-page summary of its 2-year study of lawyer advertising and solicitation to the District Court,” as well as an “anecdotal record . . . noteworthy for its breadth and detail” in upholding a thirty-day moratorium on direct-mail solicitation of accident victims and their families by personal injury lawyers. In Bronco Wine Company v. Jolly, a California appeals court held that a legislative finding that the descriptor “Napa” was inherently misleading was adequately supported by “the regulatory history of brand names of geographic significance,” hearing testimony, and a survey. By contrast, in Edenfield v. Fane, the Supreme Court invalidated a ban on in-person solicitation by accountants on the grounds that the Board of Accountancy failed to ”validate [its] suppositions[.]“
Commercial speech doctrine does not precisely specify the level of deception, or the form or degree of proof, necessary to justify speech-restrictive regulations like those that limit direct-to-consumer prescription drug advertising. The government might have to show that such advertising is more often deceptive than not. Or, as in Lanham Act false advertising cases, it might have to show that a substantial percentage (typically fifteen to twenty percent) of a company’s customers is misled by it. Or, a significant risk of deception might be sufficient. Notwithstanding this uncertainty, FDA is wise to prepare to defend (and even fend off) future First Amendment challenges to the laws and regulations governing direct-to consumer prescription drug advertising by building up the evidence base underlying them.
Filed under: Drugs & Medical Devices, Liability
Cross-Posted at Bill of Health
At the end of last month, the Secretary of Health and Human Services Kathleen Sebelius made headlines when, in a letter addressed to Representative Jim McDermott (D-WA), she announced that “[qualified health plans], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act” were not “federal health care programs under section 1128B of the Social Security Act”. One implication of the Secretary’s interpretation is that the “anti-kickback act”, which is found in Section 1128B, does not apply to qualified health plans. And that, in turn, means, among other things, that individuals insured under those plans, unlike individuals on Medicare or Medicaid, will be able to use drug company coupons to defray the cost of their prescription drugs.
Prescription drug coupons have been a source of controversy, favored by branded manufacturers and patients, and opposed by generic manufacturers, health insurers, third party payers, and pharmaceutical benefit managers. Joseph Ross and Aaron Kesselheim studied a large number of coupons advertised on the website www.internetdrugcoupons.com and found that ”62% (231 of 374) were for brand-name medications for which lower-cost therapeutic alternatives were available.” Ross and Kesselheim argue that the coupons are costly at the population level, but also for individual patients. This is because the coupons are nearly always time-delimited and the short-term savings do not typically outweigh the long-term cost of taking a branded drug. On the other hand, in an article in last week’s JAMA, Leah Zullig and colleagues pointed out that reducing co-payments has been proven to improve medication adherence, a problem which there ”is an increasing business case for addressing[.]“
The coupon controversy has carried over into the courts. On March 7, 2012, seven lawsuits were filed in district courts by third party payers against a number of drugmakers, alleging that prescription drug coupons violate antitrust, commercial bribery, and racketeering laws. (This post at FDA Law Blog includes links to the seven complaints, and this one provides an update on the status of the litigation as of late June 2013.)
On June 3, 2013, Judge Paul Oetken of the Southern District of New York dismissed one of the seven suits, brought against Bristol-Myers Squibb and Otsuka, finding that the challenged coupons were not fraudulent because the program is “‘open and notorious,’ information about its terms and conditions is readily available on a number of public websites, and Plaintiffs do not allege that anyone is deceived about the effect of these programs.” The court dismissed one of the plaintiffs’ claims–that the defendants committed fraud “by reporting benchmark prices to reporting agencies while failing to account for the routine waiver of co-pays”–without prejudice to refile, which the plaintiffs did. A review of the seven dockets this morning, November 26, 2013, reveals that there are motions to dismiss pending in all that were not voluntarily dismissed by the plaintiffs.
The likely outcome of the ongoing litigation is that if an insurer wants to end the use of coupons, it will have to include a provision in its insurance contracts barring their use. Note, though, that Ross and Kesselheim found that fully 38% of the coupons offered were for prescription drugs for which there was no therapeutic alternative. The public policy arguments against using coupons are significantly weaker with regard to such drugs.
A better approach to cutting costs, I think, is to focus on doctors, not patients. Rather than take away patients’ coupons–which can be perilous, as JC Penney can tell you–insurers and third party payers should make it easier for doctors to make cost-effective prescribing decisions and harder for them to prescribe brand-name drugs that have generic substitutes or alternatives. As Judge Oetken held, “neither precedent nor logic” supports assigning to patients a duty to “pressure physicians to choose generics.” Physicians should be choosing generics, where appropriate, in the first instance. Focusing on helping them do so would be fairer and more productive than continuing the fight against coupons.
The Federal Circuit Decides Future Lost Earnings Award Not Authorized in Vaccine Case in Which Child Died
Filed under: Bioethics, Children, Drugs & Medical Devices, Liability
The National Childhood Vaccine Act of 1986 requires parties seeking relief for vaccine-related injuries to proceed through a federal vaccination claims system. If a plaintiff prevails in her suit, she (or her estate) will receive damages for pain, suffering, and expenses. Significantly, other awards include death benefits or future earnings. On October 28, 2013, the Federal Circuit answered in the negative the question of “whether the estate of a petitioner who dies prior to judgment is entitled to compensation for lost future earnings.”
Tembenis v. Secretary of Health & Human Services arose out of the epilepsy four-month-old Elias Tembenis developed following vaccination for Diptheria–Tetanus–acellular–Pertussis. His parents filed a Petition for Vaccine Compensation but while the petition was still pending, Elias died of his disorder at age seven. In 2010, a special master determined the vaccine caused Elias’ epilepsy and death.
After the special master’s determination, Elias’ estate and the Secretary of Health and Human Services agreed on damages. The estate received a $250,000 death benefit, $175,000 for actual pain and suffering and past unreimbursable expenses, and $659,955.61 in future lost earnings. The Secretary reserved the right to challenge the future lost earnings award; the special master determined that Federal Circuit precedent suggested that the estate was entitled to lost earnings. The Secretary appealed to the Claims Court which upheld the special master’s ruling.
The Secretary then appealed to the Federal Circuit. The Circuit court analyzed 42 U.S.C. § 300aa–15(a)(3)(B):
In the case of any person who has sustained a vaccine-related injury before attaining the age of 18 and whose earning capacity is or has been impaired by reason of such person’s vaccine-related injury for which compensation is to be awarded and whose vaccine-related injury is of sufficient severity to permit reasonable anticipation that such person is likely to suffer impaired earning capacity at age 18 and beyond, compensation after attaining the age of 18 for loss of earnings determined on the basis of the average gross weekly earnings of workers in the private, non-farm sector, . . .
The Federal Circuit interpreted the language to determine the statute only allows for recovery of future lost earnings. The Court acknowledged the statute does not expressly require a claimant to be alive, but it also does not expressly state an estate can recover future lost earnings of a decedent.
The Court observed that the word “impaired” implies the victim must be living. When the claimant dies before 18, no reasonable expectation exists that she would be working after 18. Thus entitlement to a future lost earnings award is dependent upon the claimant being alive. Further, the Court stated, receiving both a death benefit and a future lost earnings award would be duplicative. The Court took pains to express sympathy to the family, noting that the death benefit of $250,000 was due to be increased as it had not been amended since the statute’s enactment in 1986. However, the amount of payment can only be changed by Congress and even if it does happen, it will be of no consolation or compensation to the Tembenis family.
In August of this year, a federal district court upheld a California ordinance requiring drug manufacturers who sell drugs in Alameda County to implement and fund a drug disposal program. This ordinance, which shifts the costs of drug disposal from local governments back to the originators of the drugs, is the first of its kind but if sustained it won’t be the last. In December 2012, PhRMA, the trade organization for drug manufacturers, challenged the ordinance on constitutional grounds, stating that it impermissibly interfered with interstate commerce. The District Court disagreed. Facing the possibility of incurring massive costs if such ordinances were implemented nationwide, PhRMA now appeals.
In response to growing concerns over the illegal resale of unused drugs and negative environmental impacts related to improper drug disposal, many communities and local governments have begun hosting so-called “take-back” programs. These programs provide consumers with a central repository for expired or otherwise unused prescription drugs and assume the responsibility for properly disposing of them. However the costs of implementing and sustaining these programs are substantial. According to PhRMA’s estimates, the start-up costs alone are $1.1 million. Additionally, operating costs could be as much as $1.2 million annually. Traditionally, local communities have assumed responsibility for funding these programs, but one county in California thinks otherwise.
Alameda County’s ordinance provides that manufacturers of drugs which are sold or distributed in Alameda County are responsible for operating “Product Stewardship Programs.” These programs must pay for the costs of “collecting, transporting and disposing of Unwanted Products collected from Residential Generators and the recycling or disposal, or both, of packaging collected with the Unwanted Product.” Additionally, the manufacturers are expected to pay administrative fees associated with enforcing the ordinance, which are estimated at $200,000 annually. The ordinance prohibits manufacturers from shifting any of these costs to the consumers.
PhRMA argued that the ordinance was a per se violation of the Commerce Clause because it discriminated against interstate commerce by shifting local costs to interstate manufacturers, who would presumably shift these costs to consumers nationwide. The District Court rejected the assertion that this was the type of discrimination which implicates the Commerce Clause. Because PhRMA failed to demonstrate, or even argue, that the ordinance favors in-state drug manufacturers over out-of-state manufacturers, the Court stated there was no per se violation of the Commerce Clause.
The Court went on to hold that the ordinance did not attempt to directly regulate interstate commerce because the ordinance applies only to activities which occur within Alameda County, i.e. the sale, distribution and disposal of drugs within that jurisdiction. Next, the Court held that the balancing test used for activities which have an indirect effect on interstate commerce was likewise unmet. Alameda County had shown a legitimate interest in regulating drug disposal for health and environmental reasons and PhRMA failed to show that its burden in funding the program outweighed those interests.
This is a case to watch. If this ordinance is upheld, similar ordinances will likely be enacted throughout the rest of California and potentially around the United States.
Filed under: Bioethics, Drugs & Medical Devices, Global Health Care
At last week’s 44th Union World Conference on Lung Health in Paris, one of the main topics of discussion was the World Health Organization’s recently released 2013 Global Tuberculosis Report. On the bright side, the report confirms a steady decline in the prevalence, incidence, and mortality of TB. The world is on track to meet the 2015 target of a 50% reduction in the TB mortality rate by 2015, as compared to 1990.
Yet, despite this good news, many aspects of the report remain disturbing. Of particular concern is the limited progress achieved in diagnosing and treating multi-drug resistant (MDR) TB. WHO estimates that, worldwide, 3.6 percent of newly diagnosed TB cases and 20 percent of previously diagnosed TB cases involved drug-resistant strains. But these averages hide considerable regional variation. In some countries, MDR-TB is estimated to be present in more than 20% of new TB cases and more than half of previously diagnosed cases.
These numbers, however, are just estimates. A pervasive concern is that national detection systems fail to identify about 1 in 3 people who develop TB. The percentage of missed cases is even greater among persons with MDR-TB: WHO estimates that less than a quarter of those with MDR-TB have ever been diagnosed.
WHO has called on the international community to scale up efforts at TB detection, as the first step in a comprehensive process of global TB care. Ideally, detection will be accompanied by access to appropriate treatment, both for the benefit of the individuals who are detected and to reduce the further development of drug-resistant strains. But, unfortunately, this is not always the way things work. In 2012, of the 94,000 TB patients detected with MDR-TB, only 77,000 were started on second-line treatments. In some countries, the treatment gap was even greater; in the African region, only half of those detected with MDR-TB were provided with second-line treatment. According to WHO, ensuring that a diagnosis of MDR-TB is routinely accompanied by access to high-quality treatment “will require high-level political will and leadership and more collaboration among partners, including drug regulatory authorities, donor and technical agencies, civil society and the pharmaceutical industry.”
In the meantime, what are the ethics of diagnosing individuals with MDR-TB if treatment will not be forthcoming? From the perspective of the individual being tested, the diagnosis comes with a host of potential harms, including stigmatization, discrimination, and even detention. If access to treatment – or even humanely administered isolation – cannot be assured, individuals who are given the choice to be tested might reasonably refuse.
At a minimum, persons who are offered MDR-TB testing should be informed of the potential consequences, both positive and negative, as they should be for any other non-trivial medical procedure. If an individual refuses to undergo testing, the burden should be on those seeking to administer the tests to show that overriding the objection is necessary for legitimate public health objectives. In settings where persons who test positive for MDR-TB are not given access to treatment, such a showing could very well be impossible to make.