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Document 47 of 60.

JULY 30, 1999, FRIDAY

SECTION: IN THE NEWS

LENGTH: 1720 words

HEADLINE: PREPARED STATEMENT OF
MS. CYNTHIA T. CULMO
DIRECTOR, DIVISION OF DRUGS AND MEDICAL DEVICES
TEXAS DEPARTMENT OF HEALTH
BEFORE THE HOUSE COMMERCE COMMITTEE
OVERSIGHT AND INVESTIGATIONS SUBCOMMITTEE

BODY:

This is the Texas Department of Health regulatory perspective regarding the on-line pharmacies. In short, it is an issue of great concern and it's an issue in need of immediate attention. The Internet serves as an electronic international hi-way for access to, and sales of both legitimate therapies, products, and practices, as well as untested, unapproved, and unsafe therapies, products, and practices. While the use of the Internet for legitimate treatment modalities has merit, the actual practices and products encountered on the net by regulatory agencies are of great public health concern. In addition, we are experiencing great difficulties in applying current brick and mortar laws which were not designed to address this technology. The Internet, with standardized and uniform regulation, could serve as a method to extend healthcare and health education. We would recommend new legislation which would require the medical practitioners to license their websites as practice locations. The pharmacists and pharmacies should also license their websites in their respective states. The home page should also be required to display the city and state of the website.
The Texas Department of Health (TDH) welcomes the opportunity to present comments to the Subcommittee on Oversight and Investigations on this important public health issue - Drugstores on the Net: The Benefits and Risks of On-Line Pharmacies. TDH is involved in the regulation of drugs and medical devices manufacturing, distribution, and possession in the state of Texas, and is very much involved in Internet sales and distribution of drugs and medical devices.
TDH's perspective regarding on-line pharmacies reflects the views of a state regulatory agency. We can appreciate the fact that technology is rapidly evolving, and that the concept of tele-medicine on the surface appears progressive and could serve as a method to extend healthcare and access. The idea and practices may have merit, but some of the actual practices encountered by state agencies are of concern, and there are difficulties in applying the current laws to these Internet prescribing and dispensing businesses.
The Internet has afforded great benefits which have been particularly manifested in the delivery of information and education to the public, and the enhancement of commerce. But such information must be viewed with caution. The information provided on the Internet is not reviewed or approved by any scientific or regulatory body, and to date no one assumes responsibility for the information provided via the cyber- hiway. As an example, we have encountered pseudo-docs presenting themselves on the Internet as physicians, when in reality they are not licensed medical practitioners. Not only is this a national concern requiring uniform regulation, the international information should be harmonized and standardized in a manner consistent with international harmonization efforts. Should new national regulations prove successful and regulatory actions are initiated as necessary, equal or similar international standards and enforcement, the control of foreign sites, products, and therapies will need to be addressed to assure international compliance. Once regulatory authority is established, each entity will then have the same or similar priorities. We're aware that this raises a completely different set of issues, but did want to point out that we see benefits as well as concerns.
We understand the main benefit of the Internet for healthcare product access: confidentiality and convenience. Since a number of prescription drugs obtained from Internet sites are those categorized as lifestyle drugs (those for improved sexual performance, weight loss, and treatment of hair loss, etc.) the Internet purchasing allows one to buy without being seen and affords one the convenience of purchasing from home, office or on the road.
This benefit could also be recognized as one of the elements which places a customer at an increased risk.
The increased risk is due to one of the checks and balances placed in our healthcare system being eliminated. Safeguards to protect patients from injuries resulting from the use of unsafe drugs and devices, unapproved drugs and devices, counterfeit drugs and devices, and the illegal practice of medicine and pharmacy have been legislatively mandated, both federally and through state legislatures. These mandates have included or implied the requirement that a patient first be seen and examined by a licensed healthcare practitioner to receive a prescription for prescription drugs and/or devices. A physician- patient relationship must be established, and until the advent of the Internet, this was understood or specifically noted as a physical on- site examination. Everyone realizes this is the ideal and, even with these mandates, errors occur in the traditional regulatory world. There are occasions in the current system when physicians will prescribe for patients without seeing them, but it is not the norm. The Internet sites utilizing questionnaires and/or surveys create a n where this is the norm. These types of Internet sales circumvent the elaborate controls our country has placed on dangerous drugs and/or medical devices, and thus the risks are increased. These also result in the majority of complaints. These controls, put into place by Congress and the states, established the physician oversight and physician responsibility for proper use based upon their education, knowledge, experience, and best practices, as well as the requirement that a licensed pharmacist dispense the prescribed drug and/or device. There are several pharmacy web sites which appear to be practicing legitimately and similarly to the currently regulated mail- order pharmacies.
Two examples highlight problems associated with on-line pharmacies. We just recently had a complaint forwarded to us where a pregnant attorney completed a survey and noted on the survey that she was pregnant. She received Propecia7, a prescription drug with significant warnings and precautions for women who are or could be pregnant. Propecia7 is strictly contraindicated in women of childbearing age due to causing severe birth defects. The survey was supposedly reviewed by the site's medical director and he approved the cyber-prescription for a pregnant consumer. This does not meet the appropriate medical standard of care because they offered a prescription for a patient they have never seen before and based solely on an on-line survey. This demonstrates what happens when safeguards established to address products classified as dangerous are bypassed. Another site (see attachments) not using a survey cyber-form, advertises Phen-fen, controlled substances, and steroids as available without a prescription. Phen-fen has been removed from the market in the U.S. due to adverse events.
There are the federal and state drug laws addressing specific drug and device regulations, and the consumer protection acts which address deceptive advertising and sales practices. Nonetheless, these were not written to control the Internet sales and deliveries from state, national, and international sources. There are limited resources available to the state and federal regulatory agencies to carry out enforcement actions. The emphasis must be placed on the word, limited. Because there is a common element of limited resources between the state and federal regulatory agencies, interagency cooperation in this regulatory arena is of particular importance. This is not necessarily problematic since interagency cooperation (partnerships, contracts, and memorandums) already exist. For those agencies not already involved in federal/state cooperative relationships, the template has been established and can easily be duplicated. This interagency cooperation should be utilized in all the areas mentioned above, as well as with education. The benefits of the Internet in education outreach must be utilized. Because this regulatory playing field is huge, oversight will be an enormous challenge, and education must be one of the components of that oversight.
Many owners of the Internet websites have advocated a position of opposition to regulatory oversight. The Intent site, Soma.com, in The Pink Sheet, April 5, 1999, was quoted that several watchdog organizations are already reviewing regulation of Internet prescription sales. Of the watchdogs referenced in their list, who they believe are providing oversight, FDA was the only one with the requisite regulatory authority. It is of little consequence that a pharmacy site does not have one of the National Association of Boards of Pharmacy's stamp of a Verified Internet Pharmacy Practice Sites (VIPPS). The verification information provided by a VIPPS seal could be obtained by the consumer via other Internet sites and information. The point is that there is no guarantee for the consumers in the self- regulatory models being proposed by Soma.com.
At a minimum, if these new prescription drug entrepreneurs are to continue their Internet practices, perhaps consideration should be given to a federal requirement that physicians who wish to diagnose and prescribe on the Internet be regulated by the state medical boards at these Internet locations. We should consider their web sites as a practice location. Additionally, the same consideration should be given to pharmacists and pharmacies practicing on the Internet. We should require licensing for these sites similar to that of mail order pharmacies. The sites and persons associated with those sites should be required to display their web-specific licenses on their home page. These should be prominently located on the home page so the consumer/patient would clearly recognize they are conducting business with a legitimate site and licensed healthcare professionals.
In our view, these practices are not benign, they present a significant threat to the public health, and they necessitate serious consideration for close standardized and uniform regulatory oversight. I would like to thank you again for allowing us this time to express our concerns, experiences, and views. In closing, we commit to continuing our time, information, and resources in supporting this effort.
END

LOAD-DATE: August 4, 1999

Document 47 of 60.


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