FDA WANTS TO BE NO.1 WEB SITE.(Food and Drug Administration)(Brief Article)

FDA wants to be No. 1 web site

Add the FDA to the horde of web sites scuffling to become the American healthcare consumer's first port of call for user-friendly, reliable information on healthcare products, their risks, and benefits. In recent months, two of the agency's leading policy makers in the drug and medical device areas have begun urging popularization of FDA drug and device information at www.fda.gov

Most recently, FDA Senior Medical Advisor Murray M. Lumpkin told Dickinson's DTC Marketer in November that putting all of the sire's drug information into lay language is a "must" that should be part of the FDA mission.

Patient awareness is becoming a more critical element of risk management, Lumpkin said. This means presenting information to them in an understandable way, even if the incidence of serious health risks is very low. Using different media, like the Internet and unit-of-use packaging with information that can't be thrown away are ideas that need to be considered, he said. "There are a lot of different tools that people can use and I think that we are going to continue to look that much harder."

Prempro DTC is educational

A new year-long DTC campaign for American Home Products' Prempro (conjugated estrogens/medroxy-progesterone acetate tablets) 0.625mg/5mg that opened in September is geared to motivating women to learn more about estrogen loss and then see their doctor to ask about Prempro. AHP's Doug Petkus told Dickinson's DTC Marketer that although the campaign's 15-second TV spots are branded, the intent is educational and informative. Supporting the TV spots, which are running on national and cable news and entertainment shows, are full-page ads in magazines targeting women over the age of 45. Among the magazines being used are Martha Stewart Living, Ladies' Home Journal, and Woman's Day. "The print ads focus on symptomatic relief provided by Prempro and prevention of osteoporosis," Petkus says.

Anti-DTC group names targets

RxIntelligence, a Blue Cross and Blue Shield company established to counter DTC ads by providing what the Blues say will be credible and objective information about the risks, efficacy, and interchangeability of new and existing pharmaceuticals, says its first studies will cover the generic substitution of levothyroxine, the therapeutic interchangeability of proton pump inhibitors, and the therapeutic interchangeability of COX-2 inhibitors and NSAIDs. Results are expected to be announced during the last quarter of this year.

RxIntelligence Chairman Allan Korn, M.D., who also is chief medical officer of the Blue Cross and Blue Shield Association, says the group's goal is to "give physicians and patients the information they need to make fully informed prescribing decisions. Physicians, health plans, and patients are malting treatment decisions without all of the relevant information." He expressed optimism that his firm's first efforts will "lay the groundwork for what healthcare industry leaders, policy makers, media, and, ultimately, the consumer can expect as we move forward."

Pull Renova ad, FDA tells J&J

A Johnson & Johnson Renova (tretinoin) direct-to-consumer ad appearing in the July/August issue of Martha Stewart Living should not be used again because of the misleading claims it contains, the Food and Drug Administration told the company in a 10/13 letter. The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) objected to the ad's presentation of claims that implied Renova is more effective than demonstrated.

For example, the ad prominently displayed subheaders -- "Only Renova is approved ... to reduce fine wrinkles" and "Renova actually changes your skin" -- while actual indication and limiting information was presented in a "non-prominent manner," charged DDMAC Regulatory Review Officer Cheryl Roberts in the letter.

"J&J does not prominently present that Renova must be used in conjunction with a comprehensive skin care and sun-avoidance program," she continued. Renova's approved labeling also indicates that many patients receive desired effects on fine wrinkling from skin care and sun avoidance programs and emollient creams that do not contain tretinoin, Roberts said.

What if a DTC drug were recalled?

Prescription drug product recalls are soaring -- up 60 percent in the latest 12 months. Just recently, brands like Suprax, Lodine, Synercid and SangCya, have been involved. So far, no brand has been recalled -- but what if one were? That's not a question that has caught the attention of the Food and Drug Administration's Division of Drug Marketing, Advertising, and Communications (DDMAC), which says it spends most of its time "putting out fires" instead of planning for things that haven't happened yet.

But when Dickinson's DTC Marketer asked DDMAC Branch Chief for DTC Nancy Ostrove about this, she said numerous options would be considered -- including using DTC ads to communicate a safety-related recall. That could be applicable in the case of broadcast ads that might be running at the time of a safety-related recall involving, say, just a few lots of the advertised product, Ostrove speculated. "It would depend on the circumstances," she said. "If an imminent hazard came up, it seems to me we would want to do as much as possible." Options could run the gamut from asking for a "character scroll" to accompany a running DTC ad for a drug that was being recalled, to asking that DTC ads be canceled to protect public health.

"It's not something that we've thought about," Ostrove concluded. But perhaps it is a question DTC marketers should be thinking about.

Pfizer links Zoloft and sports

Consumers will be provided depression education and treatment information as part of a joint Pfizer/Women's Sports Foundation sponsorship of "Minds in Motion Depression Awareness Campaign." Top female athletes, including Olympic soccer star Julie Foudy, basketball All-Star Teresa Weatherspoon, and diver Wendy Williams will help raise awareness that "depression is a serious medical condition that can be effectively treated with medication and psychotherapy, and some individuals can benefit from a depression treatment regimen that also includes exercise," Pfizer said in announcing the campaign.

Sports footwear retailer, The Athlete's Foot, is partnering in the campaign to feature depression awareness in-store displays throughout the U.S.

The athletes will also make special appearances at select store locations through April 2001, Pfizer said. Consumer information and treatment information, such as information on Pfizer's anti-depressant Zoloft will be provided as part of the campaign. Consumers can also answer a confidential depression survey to see if they have any of the symptoms of depression. Media partners for the campaign include Fitness, Heart & Soul, and Oxygen Media magazines and web sites www.befearless.com and www.thrive.com

Visicol links with Couric

InKine Pharmaceutical Company is partnering with the National Colorectal Cancer Research Alliance (NCCRA) as part of the company's launch strategy for its recently approved Visicol tablets (sodium phosphate), indicated for cleansing of the bowel as a preparation for colonoscopy. Visicol is the first and only FDA-approved bowel-cleansing tablet. Current cleansing products are in liquid form and require the ingestion of between one to four liters, the company said. The products are "foul tasting" and often cause nausea and vomiting. The NCCRA was co-founded earlier this year by NBC Today show co-anchor Katie Couric to raise public awareness to the nation's second leading cancer killer and improve preventive and diagnostic measures. Couric's husband, Jay Monohan, died of colorectal cancer in 1998.

FDA finds Periostat DTC ads 'violative'

Two television broadcast advertisements and a print advertisement for Collagenex Pharmaceuticals' Periostat (doxycycline hyclate) 20 mg capsules are misleading, the Food and Drug Administration's Division of Drug Marketing, Advertising, and Communications charged in a recent letter. Upon reviewing the company's advertising submissions, the DDMAC found that a 15-second "reminder" TV ad was, in fact, a full product ad because it implied Periostat was a dental product intended for the treatment of gums. For example, it stated that a dentist prescribed the drug and included "GUMS" as part of a telephone number (877 894-GUMS). The 60-second "full product" ad, the DDMAC said, was violative because it omitted certain risk information.