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FDA Draft Guidance on Ads for 'Restricted' Med Devices Could Impact Some High-Risk Genetic Tests

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The US Food and Drug Administration has issued draft guidelines outlining how sponsors should present risk information in promotional materials for drugs and medical devices regulated by the agency.

The draft guidance, titled "Presenting Risk Information in Prescription Drug and Medical Device Promotion," discusses "factors FDA considers when evaluating advertisements and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices" with regard to the disclosure of risk/benefit information.

"Restricted medical devices" are products that require pre-market approval from the agency prior to marketing, the agency notes in the document.

Based on this definition, these guidelines will have implications for diagnostic firms who have garnered PMA or are currently undergoing PMA for genetic tests deemed Class III, or high-risk, medical devices by the FDA. Specifically, the guidance could affect the way diagnostic companies market certain in vitro diagnostic multivariate index assays, which the agency has said will require either PMA or 510(k), as they are more complex than most laboratory-developed tests.

The draft document, which is open for public comment for the three months starting May 26, focuses on the presentation of risk information in promotional materials of FDA-regulated drugs and devices to physicians and consumers. "Promotional materials" include television ads, brochures, booklets, detailing pieces, internet web sites, print ads, exhibits, and sound recordings or radio ads, according to the FDA.

FDA's authority to regulate promotional materials for restricted devices is granted under 21 USC 352(n), which requires that advertisements include “a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications.” According to the law, "restricted device advertisements must not be false or misleading (21 799 U.S.C. 352(q)(1)) and must reveal facts that are material about the product being advertised, including facts about the consequences that can result from use of the product as suggested in an ad."

In evaluating promotional materials, the agency emphasized that it looks "not just at risk-related statements, but at the net impression … to determine whether the piece as a whole conveys an accurate and non-misleading impression of the benefits and risks of the promoted product."

In its evaluation, the FDA looks at how sponsors use language appropriate for the target audience; how they use writing devices such as headlines or subheads to emphasize risk/benefit information; whether they frame risk information using specific terms that accurately characterize the nature of the product; and whether they present risk data in a hierarchy, to reflect the seriousness of the risk and its commonality in the treatment population.

The agency also considers whether the quantity of risk information is balanced with the amount of benefit information, and evaluates the material's comprehensiveness in terms of risk information and to what extent it includes "material" information about risk.

"As the amount of benefit information conveyed increases, the amount of risk information conveyed should similarly increase," FDA notes in the draft guidance. The guidance even discusses the aesthetic elements of promotional materials, such as the amount of white space, the size of texts, the location of risk information, the audio quality, and the contrast between the text and background.

Most diagnostic firms market their genetic tests to physicians, and a few, such as Genomic Health and Myriad, have invested in promotional campaigns aimed directly at patients. More recently, consumer genomics firms, such as 23andMe and Navigenics, have begun advertising their genetic screening services directly to consumers.

Promotional materials by these companies are not subject to FDA regulation, since their laboratory testing services are regulated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendment. However, there have been industry-led efforts to align risk classifications and calculations by DTC consumer genomics firms and the regulation of claims made by these firms has been the subject of recent debate [see PGx Reporter 04-15-2009].

Myriad is one company who will not need to follow FDA guidelines for the promotion of its BRACAnalysis test. Two years ago Myriad launched a national promotional campaign for BRACAnalysis, a test is not regulated by the FDA [see PGx Reporter 08-12-2007].

Agendia, on the other hand, would not be subject to FDA's guidelines when marketing its MammaPrint breast cancer recurrence assay, since it is a Class II device that received 510(k) clearance [see PGx Reporter 02-07-2007].

However, when the FDA finalizes its IVDMIA guidance and officially begins to exercise enforcement over this subset of LDTs, it could have an impact on the promotional campaigns for several major diagnostics.

For example, Genomic Health is currently in discussions with the FDA over the regulatory status of its breast cancer recurrence test, Oncotype DX, for which the company launched a campaign to educate patients and physicians last year [see PGx Reporter 01-16-2008].

Genomic Health officials have indicated in the past that they will likely have to submit a pre-market application for Oncotype DX under FDA's IVDMIA guidelines, but the company has yet to submit a PMA for the test. Discussions between the company and the agency have been ongoing for several years, according to company, but the FDA has not made any announcements in this regard. In the meantime, the FDA has allowed Genomic Health to continue marketing the test under CLIA [see PGx Reporter 04-08-2009].

DxS is another company in the process of submitting a PMA — for its KRAS mutation detection assay — and will have to craft promotional messages according to FDA's guidelines. DxS' test helps doctors discern which colorectal cancer patients are most likely to benefit from certain monoclonal antibody therapies [see PGx Reporter 03-04-2009].

Similarly, the promotional guidelines would also apply to Exact Sciences, which received warning from the FDA that the PreGen-Plus colorectal cancer assay it was developing with the Laboratory Corporation of America was "misbranded" and "adulterated." The agency, in its Oct. 11, 2007, warning letter, indicated that since the companies failed to appropriately characterize the assay, it may require PMA [see PGx Reporter 01-23-2008].

In issuing this draft document, the FDA acknowledges that promotion of prescription drugs and medical devices to doctors and consumers is a "broad and complex topic." The agency cites its own 2004 survey on the positive and negative effects of direct-to-consumer advertising for prescription drugs, which found that while DTC ads increase awareness of conditions and treatments and inspire discussions with physicians, they also put pressure on the physicians to prescribe the advertised product.

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