Coalition for Healthcare Communication - Current Issues - Comments to FDA on Internet Regulatory Issues












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Comments to FDA on Internet Regulatory Issues
By the Coalition for Healthcare Communication

General Remarks
The Internet is growing at a phenomenal rate and we strongly believe that, along with the accelerating acceptance of this medium, there will be an accelerating rate of new uses, applications, functionality, and issues that do not exist today and that no one can anticipate. The coalition believes that the FDA should not craft new regulations for this medium, which is still in its infancy.

In fact, as we have made clear elsewhere, we believe that many FDA marketing and advertising rules are not consistent with providing optimum information to medical professionals and patients. Our decision to provide recommendations within the limited context of the FDA's request does not suggest a change in that position, only our desire to advance this docket and enable rigorous use of this medium for communication of vital medical data.

We view the Internet as a library where massive amounts of information are available and individual choices of what to view are made by users. Accordingly, if the FDA decides to provide guidance to industry, we hope it results in removing barriers to better communication, not constructing new ones.

Advertising or Labeling
The Code of Federal Regulations, 202.1 (1) Prescription Drug Advertisements, states that "Advertisements broadcast through media such as radio, television or telephone communication systems shall include information relating to the major side effects and contraindications of the advertised drugs in the audio or audio and visual
of the presentation and unless adequate provision is made for dissemination of the approved or permitted package labeling in connection with the broadcast presentation shall contain a brief summary of all necessary information related to side effects and contraindications.

Since the Internet actually runs over interconnected phone lines, it fits the definition of a telephone communication system. Under this definition (CFR, 202.1 (11)} the current regulations treating the Internet as a broadcast medium would apply.

The Coalition views the Internet as similar to a broadcast medium. As such, commercial messages placed by the manufacturer should be viewed as advertising. This would require the advertiser to provide, in a prominent area, a hot button that displays easy access to a brief summary of prescribing information for any corresponding promotional materials. Other regulatory requirements concerning advertising would likewise apply to these commercial messages.

If an advertiser wishes to provide full prescribing information, a hot button to display this information should similarly be in a prominent place in the advertisement.

Linking
The Notice question, "Should links from Web sites (posted or sponsored by a regulated company) which contain information about FDA-regulated products be permitted? If yes, what parameters, if any should be established for these links without violating the Act?"

Our answer to the first question is "yes", of course, links should be allowed; no known harm or serious threat of potential harm has been demonstrated that would permit such restriction on communications rights. Therefore, we see no need for regulations in this area. Companies preparing such links may find the following guidelines useful:
&Mac183; If the site you are linking to was supported by your company in any way (unrestricted educational grant, funding the construction of the site, sponsoring some of the content, etc.) be sure to prominently notify visitors of this information.
&Mac183; Link to the home page of the site to inform the user who is providing this information.
&Mac183; Provide a variety of links to sites you have reason to believe are accurate, timely, balanced, and scientifically sound, and offer the user valuable information. Use reasonable efforts to monitor these links to ensure their continued adherence to these standards.
&Mac183; Provide a disclaimer stating that the links are to independent sites, and that any information on these sites concerning company products has not been reviewed or approved by the company.
&Mac183; The Internet gives people more information choices and empowers them to evaluate all points of view. These are two of the reasons the Internet is enjoying such tremendous growth. It would be bad public policy and totally inconsistent with the global culture of the Internet to ban linkage to other Web sites on the basis that it violates the U.S. Food, Drug and Cosmetic Act.

Fair Balance
"How should product information be presented on the Internet to ensure the user has access to a balanced presentation of both side effects and contraindications and information relating to its effectiveness?" "Should fair balance be considered in the presentation of information on every screen? In every advertisement or promotional piece? Or on the entire Web site?"

We agree that FDA-regulated companies have a responsibility to provide fair balance about their products regardless of the medium they use to communicate this information. The Internet poses several challenges on how to best accomplish fair balance. For example, there is no such thing as a typical screen size. Desktop monitors are bigger than laptop monitors. Some computer uses have multiple applications open at the same time and may look at the Internet through a small window on their computer while others prefer a full-screen view. People can use different font sizes and may choose to turn off the graphics to download files faster. This means that any regulations requiring fair balance on every screen simply won't work.

The Coalition believes a reasonable interpretation of the regulations is for FDA-regulated companies to adhere to the concept of requiring fair balance information, as appropriate, in every advertisement. The content of fair balance will depend on the specific claims or statements made in the advertisement, as is currently the case with print advertisements.

Physician-Directed Versus Consumer-Directed Information on the Internet
"Is it necessary to distinguish between promotion directed to health professionals and consumers on the Internet?" the Notice asks. "If yes, how should Web sites clearly make the distinction between professional-directed and consumer-directed promotion?"

It is the Coalition's understanding that the FDA is actively considering the responses to the May 14, 1996 Federal Register Notice regarding Direct to Consumer Promotion. How the FDA proceeds on this issue will have a significant impact on the Internet along with all the other media. It may be premature to comment on how this should be handled on the Internet without the benefit of knowing the FDA's point of view on the issue as a whole.

However, it does make sense for companies who already have approved, consumer-friendly labeling to offer consumers this information in connection with product promotion on the Internet. A simple set of buttons saying "for consumers" and "for health professionals" should be all that's needed to identify the intended audience for this information. If would be helpful to use technical medical terminology in the information intended for health professionals, thereby making its target audience clear to the Internet user. The consumer areas should be presented in less technical language and at a level that is easier for the lay public to understand.

Some companies may want to include (on their Web site) sensitive information intended for healthcare professionals only. Internet technology allows for password-protected areas for sensitive or confidential information, and the Coalition recommends using this feature when appropriate.

Investigational Product Information
"To what extent should information about investigational products or investigational uses be presented on a sponsoring company's Web site? Is there a way to distinguish between the presentation of this information for economic, educational, or promotional purposes?"

There may be numerous areas of a sponsoring company's Web site where it makes sense to include information about investigational products or uses. Annual reports for many companies typically include this type of information. It is not unusual for companies to also post their annual report information in a financial or corporate information area on their Web site. There may also be a disease management or disease treatment area of a company's Web site where visitors can find out about clinical trials being conducted for drugs or devices that may prove helpful for a specific disease or condition.

The Internet is emerging as an efficient way for companies to recruit patients for clinical trials of investigational products and/or new uses of existing products. Accordingly, it makes sense for companies to inform these patient populations about Investigational Review Board (IRB) approved trials for products they manufacture.

In addition, to facilitate communication with investigators, sponsoring companies may want to make available a special password-protected area for clinical investigators to review trial data, share information, and communicate with each other in chat sessions or bulletin board postings.

International Issues
"How could promotion of products manufactured or distributed by a multinational companies be presented on the Internet without violating the Act and regulations?"

"What factors should FDA consider in determining whether a company is attempting to promote a product in the United States, which is approved for a use in another country, but not so approved in the United States?"

We recognize that the Internet is an international medium and that neither regulated companies nor the FDA can effectively block the transfer of data and information across country boundaries. Thus, we believe that the FDA should accept as sufficient reasonable efforts by companies to comply with the substance and spirit of FDA regulations. Current practice demonstrates the abundance of care currently being exercised by companies.

For example, the Coalition notes that many regulated companies put a notice at the top of their Web site that clearly states who is claiming responsibility for the site, for which area of the world the information is intended, and a disclaimer about the relevance of the information in other parts of the world. Also, companies often display a message, icon, graphic or other reasonable means to identify the intended audience, beyond the home page of the Web site. This helps visitors arriving at a site, via a search engine, for example, to understand that the information on the site is intended only of r users in the United States of America, without having to go to the company's home page for clarification.

Further, multinational companies with web sites in different areas of the world are now promoting the availability of each of their Web sites only in the areas of the world where the information is appropriate. However, we believe that multinational companies should be allowed to offer links to other operating units/companies as long as the domain information is clearly labeled.

Chatrooms and Newsgroups
"Should parameters be established for company participation in sponsorship of chatrooms or newsgroups that discuss the company's products? If so, what should they be?"

We recommend that when a company wants to offer this type of feature for physicians on their web site, they consider providing an unrestricted educational grant to an Accreditation Council for Continuing Medical Education (ACCME)-approved provider to run the sessions. This should guarantee the independence of the information and ensure a balanced, scientifically sound oversight of the topic being discussed. ACCME guidelines would suffice for these activities.

Companies that sponsor or host chatrooms or newsgroups that are available to the public should follow the same protocols as if these discussions were held in the company auditorium. The Coalition does not believe the FDA needs to establish parameters for this activity.

In Conclusion
The FDA has been studying, discussing and monitoring the Internet for over a year now. Many FDA-regulated companies have been waiting for guidance before they become involved with the Internet. Others have visited the FDA to present their Internet plans and get an approval to go forward. Those companies that have decided to post information on the Internet without FDA "pre-approval" have been conservative in their approach, having to guess how the FDA may interpret and apply the existing regulations to their Internet initiatives. We believe the FDA should evaluate the responses from the Federal Register Notice and move quickly to provide guidelines for Internet use by FDA -regulated companies.

The Coalition for Healthcare Communication believes the Internet is the most significant advance in communications since the invention of the printing press. We respectfully submit that the development of this vitally important communications medium should not be discouraged by unreasonable governmental restrictions and regulations.

Jack Angel
Coalition for Healthcare Communication

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