Remarks by:

Jane E. Henney, M.D

Commissioner of Food and Drugs

"This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some of the material may have been added or deleted during actual delivery."

Good morning, it is a pleasure to be here to participate in your Executive Officers Conference. First, I would like to note that we at the Agency value the working relationship that we have with the NABP and the State Boards of Pharmacy. Our work toward the common goal of protecting the public health intersects and complements each other's in many important ways.

By working together in various areas, we are providing the American people with a safety net that guards them from harm. Over the past century, Congress and state legislatures have enacted safeguards to protect patients from injuries resulting from the use of unsafe drugs, counterfeit drugs, and from the improper practice of medicine and pharmacy. This system of drug regulation has served us well.

Time is limited, therefore, I would like to just touch upon a few areas this morning-including the sale of medical products over the Internet, direct-to-consumer advertising, pharmacy compounding, and the creation of a transition class of drugs.

First, there is one area of extraordinary promise, but also regulatory challenge-the Internet. I would like to applaud the NABP's efforts in developing and implementing the VIPPs program, which is a significant step in protecting the public health and dealing with this new medium. I know that you devoted much of the time yesterday to this important issue.

Clearly, the sale of consumer products over the Internet is growing exponentially now, including the sale of drugs and other medical products. Online prescription drug sales by reputable pharmacies is one area that could benefit consumers. The ability to order new and refilled medications, and to receive information on how to use a medication properly, at any time of the day, makes this process much more efficient. Access and convenience-particularly for those who are disabled or those who live in rural or frontier areas--privacy, and sometimes cost savings can be beneficial attributes of online drug sales.

We at FDA also use the power of the Internet to provide information to the public about FDA-regulated products, and we rely on this medium as a way for manufacturers to provide data regarding their products. The Internet can be a tool in providing information to patients and consumers-enabling them to make risk/benefit decisions about their health care.

However, the Internet also provides increased risks to unsuspecting purchasers and some unique challenges to State regulators, health professional organizations, and Federal law enforcement agencies. Our collective concern is focused on the public health implications of Internet drug sales, where the patient or consumer is able to bypass all the traditional public health safeguards set in place by not only the States, Congress, and the FDA, but by the licensing boards and individual health professionals who write prescriptions or dispense medications. A short list of the risks to the consumer or patient who bypasses this system includes: increased risk of side effects from using inappropriately prescribed medications, dangerous drug interactions, contaminated drugs, and the possible ill effects of impure or unknown ingredients that may have gotten into unapproved drugs during the manufacturing process.

Of particular concern are those web sites offering to prescribe drugs based only on a questionnaire. Unlike the traditional relationship between a patient and the patient's healthcare practitioner, many online practitioners issue prescriptions in the absence of a physical examination or direct medical supervision. As a consequence, patients are more likely to inappropriately receive a medication, thereby placing themselves at even greater risk for side effects and drug interactions. By avoiding the inconvenience of an office visit, a patient may also have foregone the one opportunity for a healthcare practitioner to correctly diagnose the true cause of his or her condition or identify a contraindication to the use of the sought after medication.

FDA's role in making premarket review and prescription designation decisions was established to safeguard the public health. Congress requires that FDA classify certain medications as prescription drugs for a reason -- because these drugs cannot be safely used by patients without a practitioner's supervision. Although patients can provide false or incorrect information both online and during an office visit, a face-to-face encounter allows the practitioner to take into account each patient's individual needs and then conduct a physical examination.

One example of a potential situation that illustrates why a physical examination is important would be a case where a person with anorexia nervosa or another eating disorder would like to receive a prescription for a diet drug. Any health care practitioner who could examine the patient would see that such a prescription would be inappropriate. However, if the person could receive the product from an online pharmacist, a prescriber would not be able to fully evaluate the situation and the potentially serious health risks involved.

In addition, a real-life example that the Agency has heard about involved a 16-year old boy with gender identity issues, who, through discussions in a chat room, was targeted by an adult male who supplied the boy with prescription drugs normally prescribed for pre-sex change patients. These examples illustrate just some of the dangers that could potentially occur with this medium.

We at the Agency are currently responding to concerns about Internet sales as part of our overall goal of developing and implementing risk-based strategies to strengthen public health protections.

In this effort, we are expanding our enforcement activities against illegal online sales through collaboration and coordination with other interested parties. We are also increasing our public outreach efforts to warn consumers about dangerous practices involving Internet sites that sell drugs not approved by FDA, or sites that offer prescription drugs with little or no involvement or interaction with a health care professional.

In particular, we are working together with you. FDA values its partnerships with the State Boards of Pharmacy, Boards of Health, and State Attorneys General in order to effectively take action against the illegal sale of prescription drugs in the United States. We are sensitive to the regulatory framework for the practice of pharmacy and the practice of medicine. Therefore, when a case involves either of those practices, we will be consulting and working with the relevant state regulatory and law enforcement officials. Our joint principles of understanding on the sale of drugs on the Internet, which have been signed by officials at FDA, the NABP, and the Federation of State Medical Boards is a tangible expression of our partnership agreement. We are optimistic that by working together in this area, patients and consumers will be better protected from some of the dangers associated with online prescription drug sales. A specific challenge that we face when working with individual states is the problem of a state having no jurisdiction beyond its borders. This readily opens up the opportunity for illegal practices to be carried on between and among several states. For this reason, we feel it is important to have a Federal presence so that the message that there is no safe haven for illegal activity in this area can be clearly and effectively delivered.

Individual practitioners and patients can also assist in curbing illegal and unethical Internet drug sales. Before buying a prescription drug over the Internet, patients should be encouraged to check to see if the online pharmacy possesses a valid pharmacy license and has met state practice standards. At a minimum, patients should not buy drugs from web sites that (1) offer to prescribe for the first time a prescription drug without a physical exam, (2) sell drugs not approved by FDA, (3) do not offer the opportunity to ask questions of a registered pharmacist, (4) require that the consumer link to another web site to purchase the drug, or (5) do not provide a U.S. phone number and address to contact for questions.

Physicians, pharmacists, and patients should be encouraged to report potentially illegal web sites either to us, or to you, so that the appropriate actions can be taken. Health professionals can play a pivotal role by educating patients about dangerous practices on the Internet and encouraging state law enforcement and regulatory officials to take action against physicians or pharmacists who engage in illegal and/or unethical online practices.

I would now like to change direction and focus on another area of interest to this audience--direct to consumer broadcast advertising. Providing truthful, balanced, and non-misleading information to patients and consumers can be a very good thing. People believe that more information allows them to make more informed choices about their health care, and allows them to play a more active role as their own risk managers. Accurate direct to consumer advertising allows patients to be more informed when they speak to their doctors or pharmacists, and to communicate more effectively with them.

In one recent survey, confirming earlier results, about a third of patients who saw an advertisement for a medicine they are taking said that seeing the ad made them more likely to take their medicine regularly, and a third of them reported that seeing an ad reminded them to get their prescription refilled. Studies also indicate that direct-to-consumer advertising brings more people in to see their doctors, prompting them to deal with health issues that they may have otherwise ignored. In one recent survey, 14 percent of consumers reported that after seeing DTC advertising, they talked about a medical condition or illness that they had never previously mentioned to their doctor. Further, if consumers know more about the risks of their medications, they may be more likely to be alert to side effects as well as symptoms of adverse reactions, and to report them earlier, when side effects, or something more unexpected can be dealt with more effectively.

Some critics of direct to consumer broadcast advertising suggest that what is really happening is that patients are now seeing a DTC ad and demanding medications from their doctors that they do not actually need. However, while the amount of DTC ads has dramatically increased in recent years, the number of prescriptions written in response to specific requests does not appear to have increased. In fact, it could be argued that due to DTC advertising, patients are now talking to their doctors after receiving more accurate and balanced data, as opposed to information traditionally received through word of mouth from friends, relatives, or neighbors.

The most important message that we at FDA have tried to stress regarding DTC advertising is that a manufacturer must give the whole picture. When discussing the benefits of a given product, the risks must be effectively communicated at the same time. These requirements come directly from our statute and regulations-this information must be truthful and non-misleading, and part of being "non-misleading" is providing an adequate amount of risk information when discussing the benefits of a product.

In August of this year, the Agency issued its final guidance on broadcast direct-to-consumer advertising. The guidance presumes several things about all direct-to-consumer advertisements: the advertisements are not to be false or misleading; prescription drug products are to be advertised as being available only through a prescription-only a healthcare professional can decide whether they are appropriate for a patient; the ad must maintain a fair balance between effectiveness information and risk information; and the information about the product's most important risks (major side effects and contraindications) must be communicated in consumer-friendly language.

The main point of the guidance is to provide information regarding ways to comply with the "adequate provision" requirement for broadcast advertisements-- mandating that manufacturers make package labeling information for the advertised drug readily available to the public in connection with the ad. The guidance suggests that multiple methods for disseminating this information are needed: a toll-free telephone number, a reference to another advertisement in print, a reference to an Internet page, and disclosure that healthcare providers may provide consumers with additional information about the product.

This guidance has been issued to communicate relevant information to manufacturers and aid them in complying with our regulations. We have made a great effort to work with sponsors to help ensure that their advertising is in compliance with the applicable laws.

There are instances that remain where the direct marketing of certain types of drugs to consumers has raised important public health issues, including ads for controlled substances, antibiotics, and psychotropic drugs. We are continuing to work with sponsors to sort through an appropriate way to communicate without changing risks and benefits of the product in question.

A critical analysis of direct-to-consumer advertising will be needed to understand and see its effects on patients, consumers, prescribers, and the health care system as a whole. At the time of the 1983 moratorium on DTC, there was very little study data in this area. Sixteen years later, many holes still exist in our knowledge about the effects of DTC. But we are now getting better consumer information, including: an AARP study, a National Consumer's League study, and surveys conducted by Time, Inc. and Prevention magazine. In addition, some professional groups and managed care organizations would also like to see more information on the costs and benefits of DTC to doctors, and to the health care system as a whole. These are some areas where data gaps exist, and future study in this area would be beneficial.

I would like to shift the discussion to another important area that raises complex regulatory issues-pharmacy compounding. As many of you know, the Food and Drug Administration Modernization Act of 1997 brought many changes, including the new pharmacy compounding provision in section 127 of the act. Since the time of enactment, the Agency has done a great deal of work to implement this provision.

First, we have established an advisory committee on pharmacy compounding, which has met twice. We have also issued proposed rules on the bulk drug substances that may be compounded, as well as a list of those drugs withdrawn from the market for reasons of safety and efficacy, which may not be compounded. In addition, our work with the NABP has resulted in a first draft of a Memorandum of Understanding with the States. This MOU addresses state investigation of complaints relating to compounded drugs and the distribution of inordinate amounts of compounded products across state borders.

The draft MOU has been issued to the public for comment, and we are currently reviewing the feedback we received. We plan to work with NABP on how to address the many comments received and resolve issues raised by affected parties. These have been our initial steps to implement the statutory provision.

In the coming months, we will continue to hold advisory committee meetings. One of the topics to be addressed at a future meeting will involve the issue of drugs that are demonstrably difficult to compound. The agency is also currently developing general regulations that will implement the statutory provision under the Modernization Act by defining terms used in the Act, and describing how the Agency will interpret the provision.

I should briefly note that the U.S. District Court for the District of Nevada recently held that two speech-related restrictions in the FDAMA provision on pharmacy compounding violate the First Amendment. This section of the law exempts compounded drugs from certain requirements for drug approval, current good manufacturing practice requirements, and adequate directions for use, under certain conditions. The provisions at issue provide that in order to qualify for the exemption, the compounded product may not be based on a solicited prescription, and the pharmacy, pharmacist, or physician must not advertise or promote the compounding of a particular drug, class of drug or drug type. The agency is currently reviewing the court's opinion and considering how to proceed. In the interim, we will continue to work on implementing the other parts of the provision.

One last area that I know is of concern to your organization is the creation of a "transition class" of pharmaceuticals that would be sold only under the supervision of a registered pharmacist, and only under certain conditions. First, it is a very good thing that we are constantly questioning the current system in an effort to find ways to increase patient access to medical products in a way that does not create unnecessary procedural hurdles, yet provides adequate safeguards for patients and consumers. However, weighing the balance, we do not believe that the creation of another class of drugs is needed since there is a formal process in place to establish when a prescription product is appropriate for OTC use.

In closing, I would just like to reiterate that our collaboration together on issues involving the public health is extremely important and beneficial to us collectively, and more importantly, to patients and consumers. In the words of Henry Ford, "Coming together is a beginning, staying together is progress, and working together is success." I look forward to our continued work together in the future. Thank you very much for your invitation to be here today.

(Hypertext updated by tg 1999-NOV-12)