HHS NEWS

U.S. Department of Health and Human Services

P99-15                                                  FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE                                   Print Media:         301-827-6242   
July 30, 1999                                           Broadcast Media:     301-827-3434
                                                        Consumer Inquiries:  888-INFO-FDA 

FDA ANNOUNCES NEW EFFORTS TO HELP CURB ILLEGAL PRESCRIPTION DRUG MARKETING ON THE INTERNET

"While the growth in online drug sales by reputable pharmacies is a trend that can benefit consumers, irresponsible and illegal prescribing and selling of drugs online can place consumers at unnecessary risk," said Jane E. Henney, M.D., Food and Drug Administration Commissioner. "Working with other federal and state agencies, we hope to maximize the potential benefits of the Internet by curbing these illegal and dangerous activities."

Under federal and state law, generally a patient must be physically examined by a licensed health care practitioner before receiving a prescription drug for the first time. The patient then has the prescription filled by a registered pharmacist working in a licensed pharmacy that meets state practice standards. While reputable online pharmacies can be of great assistance to consumers--many even allow patients to consult with pharmacists from home--Web sites can be easily created to look like legitimate pharmacies when in fact both the sellers and the products are illegitimate. The FDA action plan has been triggered by the increasing number of Web sites -- both in the United States and abroad -- that sell potent drugs without valid prescriptions or without meaningful interaction with a physician or other health care professional. Often sales are based only on the buyer's answers to a questionnaire. The risks run by patients who accept these illicit offers include adverse side effects from inappropriately prescribed medications, dangerous drug interactions, and harm from contaminated, counterfeit or outdated drugs.

FDA's action plan includes the following activities:

• Customize and Expand Enforcement Efforts. The agency will begin upgrading and expanding its monitoring of Internet violative sites to make Internet drug sales more of an enforcement priority, including initiating criminal or civil enforcement actions when appropriate. The agency will initially target its enforcement efforts on three areas: unapproved new drugs, health fraud, and prescription drugs sold without a valid prescription. Efforts will focus on areas where there is a significant public health risk. The process will be supervised by an already - appointed team of FDA specialists in enforcement, criminal investigation and drug evaluation.
• Partner with Federal and State Bodies and other Organizations. Several federal agencies, as well as the states, have the authority to regulate and/or enforce laws related to online drug sales. Because of the growth of potential cases involving the Internet, there will be instances when working with other agencies or states could result in a more effective enforcement action. FDA will continue working with various federal agencies to address illegal Internet marketing by foreign sellers. In addition, FDA has signed Principles of Understanding with the National Association of Boards of Pharmacy (NABP) and the Federation of State Medical Boards, with the backing of the American Medical Association and the American Pharmaceutical Association. These principles represent a commitment of the signatories to work cooperatively to enforce federal and state laws against unlawful sellers and prescribers of drugs in the United States.
• Engage in Public Outreach. FDA will implement other strategies to counter the illicit Web practices including outreach to alert consumers to public health risks of illegitimate online offerings.