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FDA Issues Proposed Ad Guidelines For Drugs, Medical Devices
  By Jennifer Corbett Dooren,
WASHINGTON -(Dow Jones)- The Food and Drug Administration Tuesday issued proposed advertising guidelines for drug and medical device makers with suggestions about how to properly present risk information in promotional material aimed at consumers and health-care professionals.
The draft guidelines, posted on the agency's Web site Tuesday, aren't binding, but they contain several suggestions to industry on how to avoid running afoul of agency rules. The FDA said the mission or minimization of risk information is the most frequent violation of the regulations cited in dozens of enforcement or warning letters sent to sponsors each year.
The agency said, "the public health is best served when risk and effectiveness information about drug and device products is clearly and accurately communicated."
While trade groups for both drug and medical device makers have recently established their own advertising guidelines, the FDA said the industry has asked the FDA for advice on how to comply with FDA rules, which require that information about effectiveness and risk be presented in a balanced manner.
The FDA said it looks at the "net impression" of a consumer advertisement or material given to doctors to determine if a piece conveys accurate information about a particular product.
The FDA said promotional material can be misleading even if specific individual claims or presentations aren't misleading. As an example, the FDA said an advertisement for a cholesterol-lowering drug that uses audio to lay out the drug's side effects could be considered misleading if it contains upbeat music and "discordant" images of patients benefiting from the medicine while the risk information is detailed.
The 24-page guidance document goes into detail about how fonts, the type of contrast and white space used in print materials can be used to best present risk information.
The guidelines suggest a product that requires monthly blood tests to check for liver damage should state that in clear language rather than using statements that state there's a need for "certain monitoring."
The agency will be accepting comments on the draft guidance document for 90 days before it issues final guidelines. The draft guidance document is set for publication in Wednesday's Federal Register.

US FDA warns of distracting music, images in TV drug ads
Reuters, Tuesday May 26 2009
* FDA gives advice on how to present drug risks * Avoid distracting music, images, FDA says
By Lisa Richwine
WASHINGTON, May 26 (Reuters) - Television ads for drugs and medical devices should avoid distracting images and music that can reduce viewers' comprehension of potential side effects, U.S. regulators advised in guidelines proposed on Tuesday.
Advertisements also should use similar type styles and voice-overs when conveying benefits and risks, the Food and Drug Administration said.
The guidelines follow complaints that manufacturers use various techniques in their widely seen television ads and other promotions to downplay risks while emphasizing potential benefits.
Leaving out or minimizing side-effect information is the most frequent violation the FDA cites in letters to companies complaining about misleading promotions.
The draft guidelines advise manufacturers on how to adequately present risk information in print and broadcast promotions to consumers and doctors without running afoul of federal regulations but are not mandatory.
The advice covers techniques ranging from the use of contrasting colors to highlight information, the location and timing of risk details and other factors that can influence how well viewers understand a product.
Prescription drug ads have drawn fire for portraying healthy-looking, active and smiling patients while explaining benefits and then rushing through or providing distractions when required risk information is conveyed.
At a congressional hearing last year, a Schering-Plough Corp ad for allergy drug Nasonex drew criticism for featuring a bee that flew around during a description of side effects but simply hovered while benefits were explained.
In the new guidelines, the FDA said busy scenes, frequent scene changes and moving camera angles "can misleadingly minimize the risks of the product being promoted by detracting from the audience's comprehension." The FDA also warned against speeding up an announcer's description of risks. "If risk information is considerably more difficult to hear and process than benefit information because it is presented at a much faster pace, the piece will not convey an accurate impression," the agency said.Reviewers will consider "the net impression conveyed by all the elements of a piece. For this reason, manufacturers should focus not just on individual claims or presentations but on the messages conveyed by the promotional piece as a whole," the guidelines said.
Medical device makers have adopted voluntary advertising principles that include "the need to present risk information in a manner free from distraction," said Wanda Moebius, spokeswoman for the Advanced Medical Technology Association.
The group, which represents Medtronic, Johnson & Johnson and other device makers, is reviewing the FDA proposal, Moebius said. The FDA guidelines were posted on the agency's website at (Reporting by Lisa Richwine, editing by Dave Zimmerman)

FDA Message on Drug Ads: Don't Bury Risk Information
By Sarah Rubenstein
May 27 2009WSL blog
televisionDrug companies are shifting through the FDA's latest advice on how their advertisements shouldn't overplay drugs' benefits while underplaying risks. As we read through the draft guidance, we were struck by the insights the agency offers up on how people in the audience digest advertising information.
For instance, the FDA explains, "Memory research consistently shows that, in an experimental setting, when people process an entire list or text, they are better able to recall items at the beginning and the end than items in the middle." So the takeaway for drug makers is that they shouldn't bury the most important info on drugs' risks in the middle of lengthy streams of text.
Another tidbit on the human mind, courtesy of the FDA: "The amount of information presented is one component that, together with choice of words, color, graphics, voiceover, and other aspects of the piece, can affect cognitive load, the mental effort required to understand the various components of information in the piece." So companies shouldn't make it tough to digest the risk-related info by, say, slowly and clearly reciting lots of information on drugs benefits and then quickly running through a line or two on the risks.
In its report on the FDA's guidance, Reuters notes that one ad that drew criticism in Congress last year was for Schering-Plough's allergy drug Nasonex. The ad had a bee that flew around during a description of side effects but simply hovered while benefits were explained, as Reuters describes it. A Schering-Plough spokesman tells us the company is reviewing the FDA's draft guidelines and that it reviews all of its ads to ensure they follow FDA regulations.
A spokesman for drug trade group PhRMA told Reuters that drug makers "remain committed to producing responsible, balanced promotional materials" and have adopted voluntary guidelines that say risks "should be presented in clear, understandable language without distraction."

FDA Draft Guidance on Ads for 'Restricted' Med Devices Could Impact Some High-Risk Genetic Tests
May 27, 2009
By Turna Ray
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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