FDA Seeks Comments on DTC Study

The Food and Drug Administration is seeking public comment on its investigation of the impact of communicating risks in direct-to-consumer prescription drug television advertisements.  Readers know of the importance of the DTC context in drug litigation.

The notice announcing the comment period notes that prescription drug advertising regulations (21 CFR 202.1) require that broadcast (TV or radio) advertisements present the product's major risks in either audio or audio and visual parts of the advertisement; this is often called the "major statement." There is concern that as currently implemented in DTC ads, the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects. Not all agree; one possible resolution is to limit the risks in the major statement to those that are serious and actionable, and include a disclosure to alert consumers that there are other product risks not included in the ad. For example, the disclosure could be, "This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for [drug name] before starting it."

The Office of Prescription Drug Promotion  plans to investigate the effectiveness of this "limited risks plus disclosure" strategy through empirical research, with the hypothesis that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks. 

 

The FDA invites comments by 4/21 on: 

• whether the proposed collection of information is necessary for the proper performance of the FDA's functions;
•the validity of the methodology and assumptions used;
• ways to enhance the quality, utility and clarity of the information to be collected.

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Defense Victory in Bellwether Drug Trial Affirmed

A state appeals court recently upheld a judgment for defendant in the first bellwether trial in consolidated litigation in New Jersey over claims concerning the cancer drugs Aredia and Zometa. See Bessemer et al. v. Novartis Pharmaceuticals Corp., No. A-2069-10T1 (Sup. Ct. NJ, App. Div.)


Plaintiff allegedly developed osteonecrosis of the jaw (ONJ), and had sued alleging that defendant knew or should have known that Aredia and Zometa could cause ONJ and should have issued warnings to plaintiff and her treating dentists and oral surgeons, as well as to her prescribing oncologist.  The jury returned a verdict in defendant's favor; plaintiff appealed claiming that the pre-trial grant of partial summary judgment to defendant constituted reversible error. The trial judge had decided that defendant had no duty to warn non-prescribing dentists or oral surgeons under the NY Product Liability Act. The trial judge applied the learned intermediary doctrine, rejecting plaintiff's allegation that the so-called DTC exception applied pursuant to Perez v. Wyeth Laboratories Inc., 161 N.J. 1, 14-15 (1999).

The court of appeals affirmed the "well-considered and thorough opinions" of the trial court. The two relevant opinions are: Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6052544 (N.J. Super. L.D. Nov. 12, 2010) (denying post trial motion), and Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6257855 (N.J. Super. L.D. April 30, 2010) (partial summary judgment).

Thus, the direct-to-consumer advertising exception to the learned intermediary doctrine did not apply to plaintiff; even if the drug was advertised to consumers, and even if plaintiff had seen a magazine advertisement for Zometa while taking the drug, it was not a substantial factor in her use of the medication.  The appeals court ruling also confirms that the defendant did not have a duty to warn dentists and oral surgeons (that is, doctors in a different field) of the drugs' possible risks, in addition to actual prescribing physicians. 

    

FDA Proposes Regs on Direct-to-Consumer Prescription Drug Ads

The Food and Drug Administration has proposed to amend its regulations concerning direct-to-
consumer (DTC) advertisements of prescription drugs. Specifically, the proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act, added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that the major statement in DTC television or radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. See 75 Fed. Reg. 15,376 (3/29/10). FDA is also proposing standards that the agency would consider in determining whether the major statement in these advertisements is presented in the manner required by FDAAA.

Readers of MassTortDefense know how DTC ads have impacted products litigation, from effects on the learned intermediary doctrine, to influence on the jury pool, to forming part of the basis of substantive information-based claims.

Under the current regulations the presentation of risk information in an advertisement for a prescription human or animal drug is required to be comparable in prominence and readability to the presentation of effectiveness information in the advertisement. If an advertisement presents effectiveness information in a clear and conspicuous manner, risk information is required to be presented in a comparable manner.  The new proposal would require disclosure of the major side effects and contraindications of the drug in a clear, conspicuous, and neutral manner, regardless of the manner in which effectiveness information is presented in the advertisement.

The proposed regulations would define the required clear, conspicuous, and neutral manner, as being met if:

1. Information is presented in language that is readily understandable by consumers;
2. Audio information is understandable in terms of the volume, articulation, and pacing used;
3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major
statement.

FDA said it recognizes that these standards require judgment in their application. Therefore, the agency does not intend to prescribe a set formula for ‘‘clear, conspicuous, and neutral’’ major
statements because there is more than one way to achieve these standards in a television or radio ad. FDA intends to be flexible enough to consider the variety of techniques sponsors may use to appropriately convey required risk information in prescription drug ads. Sponsors have the flexibility to be creative in designing their ads as long as all of the standards listed here are complied with such that the major statement is communicated effectively to consumers and the overall message
that the advertisement conveys to consumers is accurate and non-misleading.

Comments on the proposed rule are due by June 28, 2010.

New Voluntary Guidelines For Device DTC Ads

The Advanced Medical Technology Association has just released a set of “Guiding Principles for Direct to Consumer Device Advertising. “ The principles are intended to help assure that patients have accurate and meaningful information about health care treatment options and encourage them to speak with their physician. Direct-to-consumer (DTC) advertising can be an important tool for educating patients about advanced medical technologies, which are making life better for patients through faster recovery and better outcomes and in many cases, reducing health care costs.

The Advanced Medical Technology Association (AdvaMed) is the world’s largest
association representing manufacturers of medical devices, diagnostic products, and
medical information systems. AdvaMed members and subsidiaries manufacture nearly
90 percent of the health care technology products purchased annually in the United
States and more than 50 percent of the health care technologies purchased annually
around the world.

The voluntary guidelines contain 13 principles that support compliance with the Food and Drug Administration’s and Federal Trade Commission’s existing direct-to-consumer regulations. They also include additional principles, which include revising or withdrawing ads when new safety-risk information comes to light; excluding any content designed to minimize risk information; educating healthcare professionals about new products or new-use indications before the launch of an ad campaign; and submitting TV ads for restricted devices to the FDA at the time of an ad’s release.

The principles were not an effort to ward off regulation from Congress and the new Administration, but to respond to concerns that have been raised in the media in recent months about some DTC ads. 

Readers of MassTortDefense know that plaintiffs try to make an issue of DTC advertising in failure to warn claims, and have succeeded in some contexts in having DTC advertising undermine the traditional learned intermediary rule.
 

Senate Panel Holds Hearing on DTC Advertising of Medical Devices

The U.S. Senate Special Committee on Aging held a hearing last week to examine issues related to direct-to-consumer (DTC) advertising for medical devices. The amount of medical device advertising directed to consumers on television or over the Internet was an estimated $193 million last year, a figure that is a small fraction of the volume of consumer advertising for prescription drugs. Yet, device DTC is getting increased attention.

At the hearing, medical, advertising, and consumer experts shared with the committee their opinions about DTC medical device advertisements, including whether health risks are appropriately conveyed to consumers. The hearing was called by liberal Democratic Committee Chairman Herb Kohl (D-WI), who has apparently already decided that Congress ought to be prepared to call for a future moratorium on DTC ads for new medical devices.

Dr. Daniel Schultz, the director of the Center for the Center for Devices and Radiological Health (CDRH) at the FDA, discussed the current status of their enforcement activities related to DTCA for medical devices. The CDRH is the division of the FDA responsible for the regulation of restricted medical device advertisements.

The head of Advanced Medical Technology Association (AdvaMed), related the organization’s current policy on DTC advertising and reaffirmed the medical technology industry’s strong support for truthful, non-misleading advertising of its innovative products. AdvaMed believes that in addition to being truthful and not misleading, all DTC advertising should use consumer-friendly language, disclose relevant risk information, and encourage patients to speak with their doctors in more detail. Current FDA rules governing direct-to-consumer advertising are adequate. FDA and FTC already have extensive legal authority to regulate false or misleading advertising for medical devices. FDA has a full range of potential remedies it can bring to bear, from issuing a warning letter to removing a product from the marketplace.

Indeed, while it is unproven that any advertisement will cause a patient to take a drug – as opposed to discuss a possible prescription with a physician – it seems even less likely that a medical device ad will do anything other than stimulate a patient to ask a doctor about a device: a patient does not agree to undergo surgery unless they think they have a serious need for it.

Direct to consumer advertising is a powerful educational tool that allows patients to learn of new technologies and treatment options in a timely fashion and can help to initiate important discussions between physicians and patients. DTC advertising is an invaluable tool to enhance the exchange of information and empower patients to ask questions about their own health. 
 

Nevertheless, the rest of the hearing lineup was stacked with opponents of DTC advertising: Dr. Kevin Bozic, a professor of orthopedic surgery at the University of California, San Francisco, provided an opinion of how DTC advertising supposedly has the potential to adversely impact the doctor-patient relationship, patient education, and health care costs and quality. Next, Dr. William Boden, a professor of medicine and public health at the University of Buffalo, and Dr. George Diamond, a senior research scientist at the Cedars-Sinai Medical Center, shared the findings of their recent article in the New England Journal of Medicine, offering their opinions about how DTC advertising can theoretically affect patient understanding of medical device effectiveness and risks.

Dr. Ruth Day presented expert testimony on how DTC advertising may influence consumer behavior. Also on the first panel was Ami Gadhia, policy counsel for the Consumers Union, who testified about her organization’s petition to the FDA in December, 2007 for pre-review and specific risk disclosures for medical device advertisements.