Date: Fri, 15 Dec 2000 11:54:49 -0800

Hi everyone, 

I was invited to the FDA Commissioner's first Consumer Roundtable discussion, which was held this week. The goal was for the FDA to hear consumers' concerns and recommendations. I provided this written testimony, and also spoke on one of these issues, advertising directly to consumers. I was pleased that the Director of FDA's Center for Drug Evaluation and Research agreed completely and said they were working on this issue. (Unfortunately, the head of devices, Dr. David Feigal, had already left the meeting). CPR will partner with some other organizations to try to follow-up on this issue in the coming weeks. We had already complained to the FDA about the implant ads in women's magazines, and was told they would follow up. 

This was a relatively small meeting, but even so, many consumer groups were unhappy that they didn't have a chance to talk. After the presentations on medical devices, many of us raised our hands but only about three consumer group reps had a chance to talk. That is why I made my remarks after the section of the meeting on drug safety. 

Diana Zuckerman

National Center for Policy Research for Women & Families

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NATIONAL CENTER FOR POLICY RESEARCH

FOR WOMEN & FAMILIES 

FDA Consumer Roundtable 

Statement of Dr. Diana Zuckerman, Executive Director 

December 13, 2000 

The National Center for Policy Research (CPR) for Women and Families promotes the health and well-being of women and families, by using objective, research-based information to encourage new, more effective programs and policies. We are pleased to have this opportunity to provide our views of how the FDA could better meet its consumer protection responsibilities. 

In the last year, several new, widely-used prescription drugs have been removed from the market following documented deaths and serious harm to patients. These incidents call into question the standards currently used to review drugs and devices in response to the FDA Modernization Act of 1997. We believe that consumer health and confidence are being jeopardized, as the FDA has placed more emphasis on providing choices to patients, rather than the previous emphasis of keeping potentially unsafe products off the market. In an ideal world, consumers could weigh all the potential risks and benefits and decide whether or not to use a medical product. In reality, the FDA is not doing enough to ensure that consumers are fully informed of the risks of these products. 

Direct to Consumer Advertising means that the power of expensive advertising campaigns is used to persuade patients to use medical products that may not be safe or appropriate for them. Rather than empowering consumers, direct-to-consumer advertising exposes consumers to the most effective persuasion that money can buy. The "other side" -- the package insert information that is printed in microscopic writing on the back of magazine ads or that appears on TV screens so quickly that no one is likely to read it -- is almost completely ineffective if the goal is to provide warning information to consumers. In order to protect consumers, the FDA should require that all such warnings be written in a font that is identical in size and style to that used in the ad itself, or spoken by the same kind of voice-over. In addition, the FDA should ensure that these warnings and other information are easy to read, written in the style of a patient information brochure. The language should not be technical or so small or cramped that it will not be read. Unfortunately, that is the current state of the art of much of direct-to-consumer advertising in magazines. Instead, whenever possible, simple warnings should be included in a box on the ad itself, as is used for tobacco ads. More detailed information, presented in an attractive readable format, can be presented on the back of a written ad, or at the end of an ad on TV or radio. 

The FDA also needs to do more to provide information to women's magazines and other mass media that provide health information to consumers. For example, I recently was asked to speak at a press lunch attended by health editors of women's magazines. The topic was breast implants, which most of the magazines advertise and write about. A scientist at the FDA, who had recently published an article about the high rupture rate of breast implants, was also invited to speak at this luncheon, but the FDA refused to send that scientist or any other spokesperson. The reason given was that it was not a scientific forum. Unfortunately, women's magazine editors rarely attend scientific forums. If the FDA wants to reach out to consumers, it should send experts to speak at press luncheons and other similar events, not just scientific meetings. 

Conflicts of interest undermine the integrity of FDA reviews for drugs and devices. The FDA should strive to avoid advisory committee members with financial conflicts of interest, however small. Members of FDA advisory committees and people who provide testimony at advisory committee meetings or who are cited by those providing testimony should be required to publicly disclose detailed information about their financial relationships with the products under review. In many cases, scientists and physicians from academic institutions serve as consultants to the makers of medical products, or benefit financially form the products, and some nonprofit advocacy organizations derive support form pharmaceutical companies and medical device manufacturers. The FDA needs to take these conflicts of interest more seriously. 

Medical Devices are of particular concern because they include implants that stay in the human body indefinitely. The issues I have raised above refer to both medical devices and drugs, but there are long-term safety issues that deserve special attention for devices. In the case of jaw implants and saline breast implants, for example, I have seen grandfathered devices that are approved on the basis of questionable safety data. I have heard advisory board members say that despite inadequate safety data, they assume the devices must be safe because they have been on the market for years. This is not the appropriate standard, and yet nobody from FDA responded to these public statements. These questionable approvals are particularly worrisome because advisory committee members frequently recommend post-market surveillance that is not implemented. In fact, the almost 200,000 adverse reaction reports submitted to the FDA for breast implants have never even been carefully analyzed. 

Drug safety in pregnant and nursing women is a problem that needs immediate attention. Many women have health conditions that require them to take medication throughout their lives, such as asthma, epilepsy, hypertension, and depression. Unfortunately, there are no data that adequately address safety concerns of taking medications to treat those conditions during pregnancy. Taking those drugs may be essential to protect the health of the pregnant women, and the risks to the fetus may be smaller than the risk to mother and fetus of not treating the condition. However, until studies are done to determine the safety of medications during pregnancy, pregnant women may be reluctant to take drugs whose safety for the fetus is not well established. The FDA should require testing of new drugs on pregnant women as part of the studies done for approval. In the meantime, the FDA needs to do more to ensure that all pregnant women know which drugs have inadequate safety data regarding potential harm to a fetus. A rating system for drug safety for pregnant women already exists, and this rating system should be well known to doctors and pregnant patients as the movie rating system is to parents.