The Secretary’s Advisory Committee on Human Research Protections (SACHRP) will examine four aspects of the return of research results and start with the return of general study results to research subjects.
Three deal with the return of some type of results to study participants — general results, individual results and incidental findings. The fourth is the public release of study data.
“The return of general study results is the idea that at the conclusion of a research study, there should be some effort by the sponsor, the investigator, or some other party, to proactively provide to subjects, some information about the results of the study, so they have an idea of what happened in the study,” David Forster, chair of SACHRP’s Subcommittee on Harmonization, which is considering the issue, told the full committee July 22.
In March, SACHRP directed the subcommittee to examine the release of the incidental findings. “What we ended up doing was deciding there were four issues along a spectrum,” Forster said.
SACHRP member Albert Allen noted sponsors, investigators and institutional review board are grappling with the return of results. “We have to understand that the train is leaving the station as we speak,” Allen said. There is “some urgency … on the sponsor side; we’re trying to figure out what to do and going to IRBs with this information.”
“There is no guidance on expectations,” Forster added. “IRBs, sponsors, investigators are a little bit at a loss and looking for guidance.”
“There is not a whole lot of regulatory hook here in terms of telling investigators what they need to do in this regard but there is an opportunity to think about what may be ethically appropriate,” SACHRP chair Jeffrey Botkin added. He noted IRBs can require conditions that are “well above what the regulations require. And this may well be an opportunity for SACHRP to encourage human research protection programs to have as a default position that research results are returned unless there are appropriate arguments to the contrary and then allow IRBs and programs to develop their own proposals and procedures around this position.”
Forster said one of the regulatory questions is whether the FDA would consider lay summaries of research results to be promotional.
Joanne Less, director of FDA’s Good Clinical Practice program, said in addition to the question of whether lay summaries would be promotional, “there are going to be a lot more things that you are going to need from FDA in other areas and maybe we could participate in that.”
She noted the FDA issued a regulation (21 C.F.R. §50.25(c)) in 2011 that requires specific consent language regarding trial information posted on ClinicalTrials.gov. “A large percentage of folks are not finding that summary too helpful because it is very technical,” she said. “So now we would be saying there is a summary available, but that’s not so helpful, so we are providing another summary. It seems like one place to start is to make [ClinicalTrials.gov’s] summary more substantive and more accessible to subjects.”
Less was asked whether the FDA was considering amending the regulation. “Not so far,” she said. “But I think we are probably going to have to take a look at that.” She noted the FDA worked with a number of patient groups on the specific language required to be in consent forms by the regulation. “That’s why we said don’t mess with this; it needs to go in [the consent form] the way we are describing but we may need to take a look at that. It may need to be a little bit more useful.”
Key Questions Detailed
Forster said there are a several overarching questions that SACHRP needs to consider in making recommendations regarding the general return of study results:
What is the rationale for providing subjects with general research results?
Are there risks sharing these results? “Are people going to take unwarranted action based on these study results? Are they going to think things about themselves that aren’t really accurate based on the general results?,” Forster asked. “I would not underestimate those,” Botkin added.
What are the benefits of sharing these results? “Is this information that they can use in their personal lives?”
There are also procedural questions to consider:
“To what extent do we think that this should be a planned activity that everyone buys off on [that] once a study is concluded and there is data analysis, we’ll send the results to research subjects,” Forster said.
How much detail about the return of results should be in the protocol and informed consent document? Should it be general or detailed?
What format and medium should be used for communicating the results to subjects? Should it be in a letter, phone call, e-mail, or face-to-face? “Do you send graphs, a short text summary; how do you do that?”
Who drafts the communication and who provides it?
Another key question is whether third-party review is needed.
“One question that comes up a lot is whether IRBs should view these general study result summaries,” Forster said. “What is the role of an IRB?” He noted that if a discussion of the return of results is in the study protocol and informed consent document then an IRB would review this information.
“What we are seeing now is the issue of the study being over and the sponsor calling the IRB and saying ‘hey, you’ve got this study closed and now we want to return results to subjects, do you want to see it?,’” Forster said.
Allen said one reason sponsors are going back to IRBs with questions about returning results is that when safety concerns come up during a trial, sponsors are required to notify IRBs “and ask about updating the informed consent with additional information about safety signals.” Sponsors are using that as a model for what to do with the return of results, whether they are general or specific to an individual subject. “It’s what are we already doing,” he noted.
“Maybe we need to stop thinking about the consent process as only occurring from [respect for the individual subject] and really start talking about communication among investigators, sponsors, and patients as an ongoing process,” Allen said. “Consent is the beginning of that process and the returning of results is perhaps the logical conclusion.”
Botkin suggested a recommendation may be to say that if a sponsor or investigator is going to return results, a plan for the return must be in the protocol and consent form and an IRB needs to review that plan. “Some points to consider would help IRBs and investigators know what the IRB’s main responsibilities are.” Botkin noted such guidance “could not be [tied] too tightly to any regulatory requirement but it would be a way to say that if you plan to return results, here’s the way to think about that.”
Forster said the subcommittee discussed whether the IRB review of the return of result plans should be reviewed the same way that tissue bank proposals are. “Often times an IRB will say, ‘fine, you want to set up a tissue bank, we’ll review your consent forms on collecting the tissue, we’ll review your general confidentiality provisions for maintaining it, and then when you send those tissues out, that is some other IRB’s problem. We’ll look at that general process.”
A final issue is cost, Forster said. “Some subcommittee members have pointed out that this is incredibly expensive. How much money do we want to put into this thing?”
Not All Research Is Clinical Trials
Toby Schonfeld, the U.S. Environmental Protection Agency’s human subjects research review official, noted “at the EPA we don’t do clinical trials but we do human subject research. What would be helpful for us would be to be able to point to an emerging standard from the research community that says … this as an ethical imperative.”
The next step, she said, would be to develop guidance and templates for different types of research. “Something like here’s a standard for the sponsor of clinical trials; here’s what investigator-initiated protocols ought to consider; here’s what should be done if you are doing social/behavioral; here’s some points to think about.
“It may not be a one-size-fits-all approach,” she said. “There are different considerations, depending on the kinds of human subjects research.”
SACHRP member Pilar Nicole Ossorio added that “there might be different levels of interest from participants and different kinds of constraints with respect to different kinds of studies. Different studies may have different kinds of opportunities, needs and expectations on the part of the people who are thinking about those studies.”
Allen added that although different types of research may need varied “practical interpretation and application, we do need to make sure, whether the trial is sponsored by [industry], NIH or investigator-initiated that the same principle of returning results in clinical trials should apply because I think that needs to be agnostic regarding sponsorship.”
“There really is a strong ethical obligation here to figure out the right way to do this,” Botkin said.
Forster said the subcommittee would work on the issue of returning general results and should have recommendations to the full committee for its Oct. 29-30 meeting.
A California watchdog group said the FDA’s draft guidance on informed consent, which was issued July 15, does not address a need to include a more thorough discussion of pre-clinical testing for drug trials.
The group — the Center for Responsible Science — sent a citizen petition to the FDA at the end of May requesting 21 C.F.R. §50.25(a), which sets out the basic elements of informed consent, be amended to include three statements on pre-clinical testing:
“The drug you will be given has been tested in animals and by other laboratory methods to determine whether it is likely to be safe and effective in humans. The decision to allow testing of this drug on humans relies heavily on the presumption that animal tests predict human response. Due to differences between animals and humans, animal tests may not predict whether a drug is safe and/or effective for use in humans.
Some participants in clinical trials in which other investigative drugs were tested have died or have been seriously injured by the drug that was tested.
The drug you will be given may later prove to be either unsafe for humans or ineffective in treating the condition for which it is being tested. You should not assume the drug will treat a medical condition you may have, because a determination of efficacy in an animal study does not necessarily predict efficacy in humans.”
“Since the current drug development paradigm relies heavily on preclinical animal data, human subjects participating in drug trials are subject to unquantifiable risk. Because risk exists that cannot be eliminated, FDA regulations must mandate that prospective clinical trial participants receive adequate disclosure and warnings,” the petition said.
“In light of the evolving ethical standards and our increased scientific knowledge, the current informed consent regulations are deficient in the context of drug development, as they do not mandate provision of complete information regarding the risks that human subjects accept when participating in a clinical trial,” the petition added. “Trial subjects must receive all information that a reasonable human subject participating in a clinical drug trial would find material. Accordingly, the regulations must be updated to ensure that every prospective trial participant receives the information necessary to evaluate the real risks posed and to provide true informed consent.”
The petition noted that “while it is arguable that offering true informed consent to potential research subjects could reduce the number of subjects willing to participate in clinical trials or increase the cost, no data exists to support this notion.” However, if the proposed additional elements do cause a reduction in the number of trial subjects, that might “prompt the FDA to move more quickly to validate and qualify safe and effective human derived drug testing methods, and spur on the scientific community’s efforts to develop and use more predictive preclinical models.”
The FDA is moving forward with a planned study on how teenagers process the risk/reward information found in direct-to-consumer (DTC) drug promotions. In a July 21 Federal Registernotice, the FDA announced that the study — which the agency proposed back in October — had been sent to the White House’s Office of Management and Budget for review and approval, the final step in authorizing the research.
According to the notice, the planned research is largely unchanged from the October proposal: the FDA wants to show more than 5,000 teens and young adults a promotion for one of two fictional drugs and ask them questions designed to gauge whether adolescents’ developing brains process risk and benefit information the same way adults do. The FDA is concerned that teens may pay more heed to a drug’s immediate benefits than to associated risks that manifest gradually. Because some drug makers are targeting teens with DTC ads for drugs with serious risks, such as suicidal ideation, the agency wants to better understand how teens weigh risk and reward.
The current version of the proposal had only minor changes from the version proposed last year. A test run of the study originally set at 1,061 participants — one intended to iron out any issues beforehand — was whittled down to 920 in the proposal’s latest incarnation. Additionally, some new questions have been added to a questionnaire used to screen potential participants beforehand in response to 10 comments the agency received on the original proposal.
Participants will be randomly assigned to either a promotion for a fictitious acne drug or a bogus attention deficit hyperactivity disorder medication. According to the notice, participants will be broken down into four distinct groups:
young teens (13-15);
older teens (14-19);
young adults (25-30), whose responses will be compared to the two teens groups; and
a sampling of parents of participating teens, to explore “similarities and differences in perceptions” between the parents and their children, since teens “typically depend on their parents for prescription drug purchases.”
The promotions will be on a website and will include an embedded video for the drug, akin to a DTC television ad, the notice states.
As federal agencies continue to work on revising the Common Rule, the Department of Health and Human Services’ Office for Human Research Protections (OHRP) also is working on several other guidance documents dealing with the transfer of oversight of protocols between institutional review boards and studies comparing “standard of care” treatments.
“The Advance Notice of Proposed Rule Making [ANPRM] to revise the Common Rule regulations is quite active and being worked on,” OHRP Director Jerry Menikoff told the Secretary‘s Advisory Committee on Human Research Protections (SACHRP) July 21. “Occasionally we hear rumors that it is stagnant and that is definitely not true. There is a great deal of interest in this on the part of the federal government and we are hopeful that something will actually come to the light of day in the near future.”
HHS released the Common Rule ANPRM three years ago and has been working with the 16 other federal agencies that use the Common Rule, since to develop a proposed rule. The HHS semi-annual Unified Agenda of regulatory actions, released in May, indicated that the Common Rule Notice of Proposed Rulemaking (NPRM) was expected in September,
While the federal agencies, including OHRP, work on the Common Rule revision, Menikoff said OHRP also is working on at least two other guidance documents on the transfer of protocols between IRBs and studies involving standard of care.
In May, the FDA released final guidance on transferring IRB oversight. The guidance revised FDA draft guidance that was issued in 2012 along with nearly identical draft guidance from OHRP.
Menikoff said OHRP is working on its version of guidance on transferring IRB oversight and that the agency “hopes to have something out relatively shortly.”
Studies that involve comparing “standard of care” measures to determine which is better has been a controversial issue for several years. Last year, HHS conducted a day-long public hearing to help develop guidance for informed consent and what constitutes reasonably foreseeable risk in “standard of care” research that would have to be disclosed to research subjects.
The public hearing was conducted in part because of “widespread misunderstanding about the risks that are required to be disclosed in obtaining informed consent” for research involving standard of care, following an OHRP Determination Letter regarding the SUPPORT study.
“There is a lot of interest” in the issue, Menikoff said, and OHRP is “certainly going forward with that draft guidance, with release in the realm of the near future.”
Three states are suing the makers of 5-hour Energy, accusing them of defrauding consumers via unsupported claims and deceptive advertising.
The attorneys general for Oregon, Vermont and Washington state all filed complaints July 17 against 5-hour Energy maker Living Essentials and its parent company, Innovation Ventures, accusing the companies of violating state consumer protection laws. The complaints contend that ads for the dietary supplement present misleading doctor surveys, promote the drink as safe for teens without adequate supporting evidence and attribute the drink’s effects to a “unique blend of ingredients” when the only active ingredient in 5-hour Energy is concentrated caffeine.
“This lawsuit is about requiring truth in advertising,” Oregon Attorney General Ellen Rosenblum stated in a release detailing the state’s suit under Oregon’s Unlawful Trade Practices Act. “You cannot promote a product as being effective if you don’t have sufficient evidence to back up your advertising claims.”
According to the Washington state Attorney General’s Office, the suits stem from a “multistate investigation” of the companies’ marketing and promotional tactics, an investigation begun in 2013. In a July 17 release, the office claimed that “more states will sue [the companies] in the following weeks.”
A copy of Washington state’s complaint contends that the two companies “have made several unfair or deceptive claims” in an effort to bolster “their market share in the face of competition in the energy drink market.”
Among them was the contention in multiple ads that the product provides consumers “energy, alertness or focus” due to the effects of “vitamins, enzymes and amino acids” in each drink. But according to the complaint, Living Essentials and Innovation Ventures have “no competent and reliable scientific evidence to show they do.” Instead, the complaint argues that the product is “simply a caffeine delivery device.”
The suit cited an interview with Living Essentials CEO Manoj Bhargava in which he insisted that the drink’s effects come from the non-caffeine ingredients, and that “the caffeine is there simply to help the body absorb the other ingredients.”
But the complaint argues that the “vitamins and the amino acids contained in 5-hour Energy are typically present in the normal diet of an otherwise healthy individual and amounts consumed in excess of bodily needs are typically excreted. Describing normal metabolic functions of nutrients, then claiming that mega-doses of those nutrients … will cause consumers to function at an enhanced level, is false, and is not supported by competent and reliable scientific evidence.
Another point of contention involved promotional claims that consumers of 5-hour Energy would not experience the fatigue commonly associated with energy drinks, with ads claiming “hours of energy now, no crash later.” But according to Washington state’s complaint, the companies’ own research “showed that 24 percent of consumers did experience ‘a moderately-severe crash’ after usage. After prodding from the National Advertising Division of the Better Business Bureau in 2009, the label for 5-hour Energy was changed to include the notation “No crash means no sugar crash.”
The complaint also takes issue with a 2012 advertising campaign claiming that a survey of 3,000 physicians across the country found that 73 percent would recommend 5-hour Energy to healthy patients that use dietary supplements. The complaint contends that only 47 percent of those surveyed would be willing to recommend 5-hour Energy by name, and that the entire survey was misleading “because it was based on unsound survey methodology.” Washington state officials contend that the companies were warned in advance by an expert that the survey was not reliable but ignored the warning, rendering the entire campaign “inherently misleading.”
Washington’s final assertion is that warnings on the product label — that it should not be used by children under 12 and women who are pregnant or nursing — implies that “the product is appropriate for adolescents age 12 and older.” This interpretation flies in the face of available research, the complaint states, citing findings from the American Academy of Pediatrics.
The complaints for Oregon and Vermont largely mirror Washington’s, according to summaries provided by each state’s attorney general’s office. While there are some differences in the basis for the allegations and the requested court actions, due to differences between consumer protection laws in the states, the alleged violations are the same throughout.
Living Essentials didn’t mince words in its response to the allegations, contending that the suits were simply government “bullying” and that while some companies will “roll over, pay ransom and move on” when similarly threatened, “we’re not doing that.”
“The attorneys general are grasping at straw, and we will fight to defend ourselves against civil intimidation,” the company added.
To Learn More About State Enforcement Efforts, See ¶990.
One company’s telemarketing efforts have resulted in an Untitled Letter from the FDA. The July 7 Untitled Letter from the agency’s chief drug promotion watchdog — the Center for Drug Evaluation and Research’s Office of Prescription Drug Promotion (OPDP) — contends that a telemarketing script violates federal law by promoting a prescription drug without furnishing all necessary risk information.
The letter to Canadian drug maker Concordia Pharmaceuticals and its U.S. agent, OptumInsight Life Sciences states that a call script to promote the attention deficit hyperactivity disorder (ADHD) drug Kapvay (clonidine hydrochloride) is “false or misleading because it omits important risk information … and omits material facts,” both of which violate the Federal Food, Drug and Cosmetic Act (21 C.F.R. §202.1(e)).
According to the letter, which OPDP publicly disclosed July 16, the two-page call script used to promote Kapvay to physicians omitted most risk information associated with the drug, despite including numerous efficacy claims. A copy of the call script furnished by OPDP included only a general statement about mild to moderate adverse events, omitting the drug’s contraindications, warnings and precautions on its usage and specific types of adverse events associated with Kapvay.
The script includes a section in which telemarketers offer to e-mail physicians the full prescribing information or else direct them to a website with the information, but OPDP asserts that this is not sufficient, as all required risk information must be presented alongside efficacy claims.
OPDP has issued six Untitled Letters this year, all of which have centered on either a total absence of risk information, or in two cases, a near-total lack of risk information.
OPDP also argues that the telemarketing script fails to supply pertinent information about the product, including its full indication and important dosage information. According to the Untitled Letter, the call script refers to the product as “a treatment for ADHD,” but Kapvay’s full indication states that it is indicated for use only in combination with other ADHD therapies, something the call script seemingly neglects to mention. Another apparent omission concerned Kapvay’s dosage; while the script stated that the product should be taken twice a day, with the evening dose being either equal to the morning dose or exceeding it, OPDP contends that the script should have mentioned that the maximum indicated rate of dosage change is .1 milligrams weekly.
Finally, OPDP claims that the script neglects to disclose the product’s generic name “in direct conjunction with the proprietary name, as required under 21 C.F.R. §202.1(b)(1).
In order to address these perceived violations, OPDP asked Concordia to stop using the telemarketing script, to furnish OPDP with all Kapvay promotions containing similar violations and to devise a plan to stop using violative materials.
The FDA will have its third annual patient network meeting Sept. 10 to examine pediatric product development challenges.
The one-day meeting at the Washington Marriott at Metro Center will discuss the importance of transparency in pediatric clinical trials, how analysis of information from failed pediatric clinical trials might improve future designs for pediatric trials, and how patient input can benefit the design of pediatric trials.
The meeting is intended to help patients, caregivers, patient advocates, health care professional groups, the general public, academia, and industry learn about regulations that encourage pediatric product development, ways to advance pediatric product development and how health disparities affect pediatric product development. There will be a panel discussion on pediatric patients with rare diseases.
Register for the meeting or a webcast before Sept. 5. The FDA will post the agenda five days before the meeting.
Those of you who follow regulatory news probably are familiar with the Centers for Medicare and Medicaid Services’ (CMS) Open Payment reporting system, part of a long-delayed effort to disclose industry payments to doctors as required under the sunshine provision of the Affordable Care Act (section 6002 of the act). And CMS recently opened the system up to physicians, enabling them to review which companies gave them money and report any errors before the data become publicly accessible Sept. 30.
But as with so many other things involving CMS, some physicians logging onto the site apparently are getting more than they bargained for. According to a story in ProPublica, physicians with no known payments to their name are greeted with the following message when they sign up: “You have the following errors on the page. There are no results that match the specified search criteria.”
At first blush, this would seem to be a glitch. Given the amount of hand-to-mouse combat corporate officers working with the system have seen in the past few months, that would hardly be surprising. But according to CMS, this is how it’s supposed to look. That’s right. After spending 15-20 minutes signing on to the system, physicians with better things to do than line their pockets with industry cash are rewarded with an error message!
Several physicians who reported the message to ProPublica found it confounding, with one terming the message as “ambiguous.” I can think of a few dozen equally applicable descriptors, none of which are likely to earn me any honors from the Emily Post Institute.
My main concern with so-called intentional errors such as this is that they are inherently confusing. While the second line of the message correctly conveys that there is no information to present (since they didn’t receive any reportable payments from industry), the first line suggests that this was due to some error on the part of the user. Talk about mixed messages!
Ironically, CMS will be hosting a conference call later this week to educate physicians about using the site. Call me crazy, but it sounds like CMS needs to spend a little less time educating physicians on using the site, and a little more time educating its database programmers on avoiding interface faux pas.
After all, when your website is devoted to transparency, the last thing you want to be is opaque.
News of a recent FDA Warning Letter chiding a company for “liking” customer testimonials on Facebook has been spreading like wildfire in the weeks since its release. No doubt you’ve already heard the tale of Zarbee’s, a dietary supplement maker hit with a Warning Letter from the FDA’s Denver District Office, but in case you have not, here are the low-lights:
The June 27 letter, which was publicly released June 3, accused Zarbee’s of making drug-like effectiveness claims about its products — a serious no-no for supplement manufacturers — on the company’s website, Twitter account and Facebook page. However, what seems to have everyone in a tizzy is an allegation midway through the letter that Zarbee’s “liked” four customer comments containing inflated efficacy claims about products — one customer suggested that Zarbee’s sleep supplement treated her daughter’s insomnia — and responded positively to two similarly exaggerated testimonials.
According to the letter, by “liking” these claims, the company was actively endorsing or promoting these inflated claims, which provides the agency with “evidence of intended use” for the products, meaning it could be used against the company in legal proceedings.
News of the letter prompted several law firms to issue customer alerts on the topic, and the story even managed to escape the regulatory media bubble by appearing in Timemagazine. My only question is: why?
First off, this is not a unique case. While no one could ever accuse the agency of being ahead of the social media curve, it has issued other enforcement letters on this very subject. Back in December 2012, the Los Angeles District Office hit another supplement maker — AMARC Enterprises — with a Warning Letter over nearly identical allegations: the letter claimed the company’s website included drug-like claims about its products and that the company “liked” a Facebook post by a customer claiming the product treats cancer. While that letter did not indicate this was “evidence” of the company’s intent when promoting the product, it parallels the latest letter in nearly all other respects, and yet received little attention when it was released.
Second, this isn’t indicative of a new policy regarding social media promotion. The crux of the letter’s contention over “liking” questionable claims — that nurturing such claims without correction is effectively the same as approving of those claims — jibes with the FDA’s views on corporate responsibility for promotional claims, as described in two draft guidances issued this year. Under the draft guidances, the FDA holds a company accountable for any“communications that are owned, controlled, created, influenced, or affirmatively adopted or endorsed, by, or on behalf of” the company.
And lastly, let us not forget that this letter comes from an FDA district office, as opposed to the agency’s primary drug promotion watchdog: the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP). This means that CDER officials deemed this case too unimportant to merit an OPDP letter, since all district letters addressing promotion violations must first be vetted by CDER before being sent out, according to the agency’s Regulatory Procedures Manual.
Based on these factors, I can only conclude that in the rush to dissect a letter about exaggerated claims, some industry watchers appear also to have exaggerated the letter’s importance.
The end of the Supreme Court’s term seems like a good time to take a quick look at the Court’s current thinking on a topic that can determine much of the liability destiny of FDA-regulated companies: federal preemption of state law. It’s an area of the law that has seen (and will continue to see) lots of experimentation — and the experiments are likely to continue to have a wide range of outcomes.
Preemption arguments frequently lead to the dismissal of patients’ lawsuits filed in the wake of harm allegedly caused by a drug, medical device or other medical product. A jury’s conclusion under state tort law that a product, say, was negligently designed or manufactured, or that it didn’t provide adequate warnings can be determined to be preempted in some circumstances — depending on the type of product, the particular facts of the case, the claims asserted and other factors.
In the world of medical devices, back in February 2008 the Supreme Court seemed to define those circumstances pretty clearly for some products. In Riegel v. Medtronic, the Court held that for devices approved by the FDA through the agency’s premarket approval (PMA) procedure, claims brought under state common law that challenge the product’s safety or effectiveness are preempted by federal statute.
Basically, because the statute governing the FDA’s authority over medical devices prohibits states from imposing requirements for devices that are “different from, or in addition to” federal requirements, the Court determined, a court’s determination that a PMA device was negligently designed, labeled or manufactured under state common law would add state law requirements to the device — requirements that the federal statute expressly prohibits.
In its opinion in Riegel, the Court was careful to note that if a state law requirement is not “different from, or in addition to” the federal requirements for the device — in other words, if state law provides a damages remedy that is “premised on a violation of FDA regulations” — a plaintiff could bring a so-called “parallel” claim for those damages that would not be preempted.
The Court faced an important case involving this idea of “parallel” claims during this past term.
The Ninth Circuit — the federal appeals court that hears appeals from federal district courts in nine Western states, including California — allowed a claim to be brought against a device manufacturer despite the company’s insistence that the claim was preempted.
In the case, the patient and his wife alleged in their lawsuit that the company knew about problems with the PMA device but failed to inform the FDA about the problems — through the adverse event reports that the manufacturer was required to submit to the agency about device problems. If the FDA had known about the problems earlier, the plaintiffs claimed, the patient’s injury could have been avoided. Because of this failure to report the problems, the plaintiffs alleged that the manufacturer breached a duty under Arizona law to use reasonable care in warning of the risks associated with its product.
Originally, a three-judge panel of the Ninth Circuit decided that the claim was preempted. The panel held that through their claim the plaintiffs were basically just attempting to enforce an FDA requirement. A 2001 Supreme Court decision held that such state law claims would interfere with the FDA’s ability to set its own enforcement policy and priorities and therefore are “impliedly preempted.”
However, after the plaintiffs asked all the judges in the Ninth Circuit to review the three-judge panel’s decision, the judges of the circuit reversed the decision — holding that the plaintiffs indeed could raise their Arizona law failure-to-warn claim.
The manufacturer then asked the Supreme Court to review this decision. After the parties had fully briefed the case, the Court asked the solicitor general — the official in the Department of Justice who litigates cases in the Supreme Court on behalf of the government — for his opinion on whether the Court should hear the manufacturer’s appeal.
For several reasons, in his brief the Solicitor General urged the Supreme Court not to review the Ninth Circuit case. Less than a month after it received the brief — and nearly 15 months after the manufacturer first asked the Court to review the case — the Supreme Court decided that it would not hear the appeal.
This doesn’t mean that the plaintiffs necessarily win. As the Ninth Circuit noted, it may be pretty difficult for the plaintiffs to prove that if the manufacturer had been in touch with the FDA sooner about the device’s problems, the information would have reached the patient’s doctors in time for him to avoid the injury.
But for now, at least, the Supreme Court’s action means that such claims are not preempted in the states covered by the Ninth Circuit. The same claims may have a different fate in other parts of the country. (According to the manufacturer, another appeals court currently agrees with the Ninth Circuit, but two others have reached the opposite conclusion.) And sometime in the future, the Supreme Court may indeed take up the issue.
All of this means that there’s still a lot of uncertainty out there on this issue. Right now, the fate of such claims can depend in large part on where the plaintiffs file their lawsuits, and naturally plaintiffs will be looking to file such claims in a federal district court within a “friendly” circuit. Meanwhile, their attorneys will be encouraged to continue to try to match state law duties with supposedly parallel FDA requirements to avoid having the preemption trump card played against them. And device companies will continue to yearn for more uniformity and clarity from the courts.
This is Part One of a two-part posting. Next: A preemption issue involving generic drugs comes before the Supreme Court — and what the Solicitor General would have the Court say about preemption.
Those of you who follow promotional policy have no doubt already heard about the FDA’s latest social media double whammy, issuing two draft guidances June 17 covering online conduct for prescription drug manufacturers and marketers.
The first draft guidance outlines steps companies can take to compliantly promote prescription products in formats with limited characters or limited space (like Twitter or sponsored links in search engines). The second draft document gives industry a path to follow when correcting misinformation spread about their products online by a third party (like a blogger, or a customer, or a 4-chan troll). This enables them to respond with accurate information about the product without the bother of informing the agency about the communication or running the risk of it being misinterpreted as a promotion.
Based on these descriptions and a cursory reading of the documents, it would be easy to think of both draft guidances as a helping hand from the agency to industry. Not even close. The one on correcting misinformation certainly is, and has been widely embraced as such. But the hand in the other guidance is shaking its fist in a most unhelpful manner.
The problem with the character-space limited promotion guidance is that it makes basically zero allowance for those limitations. You want to promote your product in 140 characters? Fine, just be sure to include the product’s full indication, its generic name, all serious risks tied to the drug, a link to the full risk information, and if you actually have enough characters left over to make an efficacy claim about the product, you have to include any caveats to those claims as well. By the time you’re finished, it’s less a Twitter post than a James Michener novel. And if your product has the misfortune to have a boxed warning, the agency expects even more risk information to appear. You can forget about 140 characters; you’d be lucky to fit it all in 140 pages.
It’s hard to imagine that it took the agency nearly five years to come up with a policy this stringent. The guidance on correcting misinformation has plenty of expectations as well (this is the FDA we’re talking about, after all), but is not nearly as demanding or cumbersome as the character-space limited guidance.
Think of it this way: the character/space-limited guidance is pushy. It’s uncompromising and it makes a lot of demands. It’s the guidance equivalent of the Soup Nazi from “Seinfeld.” You wait patiently in line (a line that you joined back in 2009!), you agree to comply with all of its rules, and only when you reach the cash register does it decide to rescind your order. Sorry, but “No Twitter for you!”
By contrast, the guidance on correcting misinformation is considerate. It’s reasonable, even accommodating (well, as accommodating as an agency document can be). It’s a bit of a doormat. To continue with the television metaphors, it’s the Henry Blake of guidances. You want to call out people for making erroneous claims about your products without bothering to notify the agency about it? “Gee, Hawk, I don’t know, I could get in trouble. Oh, what the heck!”
This push-pull dynamic between two documents crafted in unison by the same section of the agency is a bit of a head-scratcher, and makes me wonder if they’re really representative of the agency’s ultimate vision for social media promotion. Because if they are, that’s one chaotic vision, the kind that could do with some of those mood stabilizers the agency regulates. Just make sure no one tweets about it.
As many of you have already heard, the Supreme Court yesterday ruled that companies under the FDA’s jurisdiction can sue each other over advertising and labeling claims, even if those claims comply with FDA regulations. Needless to say, this is a fairly monumental decision, one that opens the floodgates for those with cash to burn and a litigious itch. But first, some background.
The June 12 slip opinion concluded that pomegranate beverage maker POM Wonderful has the right to sue the Coca-Cola Co. under the Lanham Act over disputed claims about a juice whose labeling complied with the Federal Food, Drug and Cosmetic Act (FDCA). The dispute was based on labeling claims about a juice product made by Coca-Cola’s Minute Maid Division. While the product was labeled as “pomegranate blueberry” flavored, it contained only .03 percent pomegranate juice and .02 percent blueberry juice. And believe it or not, that’s allowed under the FDCA, which permits identification of products based on flavoring as well as content (21 C.F.R. §101.30(c)).
Well, needless to say, POM wasn’t too thrilled to find a competitor making pomegranate claims for products that are essentially just apple juice and grape juice, so it sued under the deceptive advertising provisions in the Lanham Act.
POM argued that FDA approval isn’t a bar to a competitor’s suit, since a product claim can be FDA-compliant but still be misleading enough to do a competitor economic injury. Coca-Cola argued that FDA approval precludes a Lanham Act suit because the FDCA has supremacy when the two laws come into conflict. And the federal government appeared to argue just for the sake of argument. I’m only half-joking, there. The assistant solicitor general for the Justice Department took neither party’s position, instead making the unconvincing argument that labeling claims specifically required under the FDCA should get a pass from Lanham Act suits because … well, just because.
Anyway, long story short: the court decided that neither the FDCA nor the Lanham Act has presumed supremacy when they come into conflict, but the Lanham Act wins in this case because the FDCA does not explicitly or implicitly bar suits under other federal statutes. One important note from the decision: even though the case was based on labeling claims, the high court’s ruling made it clear that the decision also applied to misleading promotions.
So, what’s this mean to advertisers and labelers? That’s a little harder to divine, because while the decision clears the way for POM to sue Coca-Cola, it doesn’t guarantee POM’s victory. If POM’s suit fails, that could set a precedential hurdle for any company following in its litigious footsteps. The right to sue over deceptive advertising and labeling claims won’t mean much to most companies if there’s little hope of a payout at the end of the process.
I say “most companies” because there will inevitably be a few mega-corporations that will use this decision as an excuse to drive smaller competitors into Chapter 11. Why out-innovate your competitors or engage in a price war with them when you can file suit on a flimsy pretense and bury them in paperwork and legal bills? Even if you lose, you still win.
Yes, I’m well aware that the Lanham Act provides for significant reimbursement to companies that stave off a “bad faith” lawsuit. Doesn’t matter. Sooner or later, one company with the chutzpah and the bankroll to test its luck will take the plunge.
Let’s just hope they don’t succeed; this industry is plenty litigious enough already.