White House Press Release.
Re: Initiative to Regulate the Sale of Prescription Drugs on the Internet.
Date: December 28, 1999.
Source: White House Press Office.

THE WHITE HOUSE
Office of the Press Secretary

THE CLINTON ADMINISTRATION UNVEILS NEW INITIATIVE TO PROTECT CONSUMERS BUYING PRESCRIPTION DRUG PRODUCTS OVER THE INTERNET

The White House today will announce that President Clinton is proposing a new initiative to protect consumers from the illegal sale of pharmaceuticals over the Internet. The initiative, which will be included in this year's budget, would: establish new Federal requirements for all Internet pharmacies to ensure that they comply with state and Federal laws; create new civil penalties for the illegal sale of pharmaceuticals; give Federal agencies new authority to swiftly gather the information needed to prosecute offenders; expand Federal enforcement efforts; and launch a new public education campaign about the potential dangers of buying prescription drugs online. The President's FY 2001 budget will include $10 million to fund these and other activities.

UNSUSPECTING CONSUMERS MAY FALL PREY TO FLY-BY-NIGHT INTERNET PHARMACIES. Use of the Internet to buy medical products is growing rapidly, and many consumers, including those in rural areas or those who cannot leave their homes, benefit from the convenience and privacy of this new option. Unfortunately, the safe use of the Internet by both consumers and businesses is now being threatened by fraudulent or disreputable Internet pharmacies that sell products illegally.

• Internet Pharmacies Can Bypass Safeguards. Traditionally there have been several safeguards to protect consumers against unsafe use of drugs, including the requirement that drugs be dispensed only for valid prescriptions and that new prescriptions be issued only after a physical exam. The Internet makes it easy to bypass these safeguards. Unethical doctors can illegally prescribe pills online to consumers they have never met in states where they are not authorized to work. Unscrupulous, unlicensed pharmacies can ship pills across state lines.
  
• Fly-By-Night Internet Pharmacies Put Online Consumers at Increased Risk. In cyberspace, consumers have no way of telling whether an online pharmacy is a legitimate operation. Consumers who buy prescription drugs online from illegitimate websites are at risk for adverse effects from inappropriately prescribed medications, dangerous drug interactions, or contaminated drugs. Some online pharmacies do not employ licensed pharmacists, removing an important safety check. And because patients can easily provide false information to obtain medications, the potential for serious abuse exists.
  
• Federal Authority to Prosecute is Limited, Penalties are Inadequate. Because of some limitations on Federal authority, it has been difficult for FDA to take action against certain offenders, such as online corporations that employ licensed physicians who prescribe drugs without taking a consumer's medical history or checking for potential drug interactions. And even where FDA has authority to prosecute, the penalties in most cases are not adequate and may not be enough to deter these fly-by-night operations.

CLINTON-GORE ADMINISTRATION TAKES NEW STEPS TO PROTECT CUSTOMERS OF ONLINE PHARMACIES. Today, the Clinton-Gore Administration will unveil a new legislative proposal that addresses these problems. Specifically, the initiative:

• Enables Consumers to Identify Legitimate Pharmacy Sites. This proposal establishes a new Federal requirement to enable consumers to identify legitimate Internet pharmacy sites. Sites would have to demonstrate to FDA their compliance with Federal and state law on pharmaceutical sales before they received approval to operate. Sites operating without first demonstrating FDA compliance would be subject to sanctions. This system would allow for rapid, coordinated Federal-state investigations and prosecutions without disturbing state systems regulating the practice of medicine and pharmacy.
  
• Strengthens the Current Penalty Structure For Illegal Pharmaceutical Sales Over The Internet. This proposal creates new civil money penalties of $500,000 per violation for the sale of prescription drug to an individual without a valid prescription.
  
• Provides New Authority to FDA in Order to Ensure Rapid and Effective Investigation of On-Line Sites. In order to streamline the investigative process, this proposal also provides FDA with administrative subpoena authority when investigating potentially illegal Internet drug sales. Administrative subpoenas would be issued in accordance with standards established by the Administration's draft privacy regulations.

In addition, the White House will also:

• Unveil A New $10 Million Investment to Target and Punish Those Who Engage in Illegal Drug Sales Over the Internet. The FY 2001 budget will invest $10 million to develop a rapid response team and upgrade FDA's computer technology to identify, investigate, and prosecute websites selling such items as: prescription drugs without a valid prescription, unapproved new drugs, counterfeit drugs, and expired or illegally diverted pharmaceuticals. This initiative will also help crack down on the marketing of products based on fraudulent health claims.
  
• Announce Plans for a New Public Education Campaign on the Dangers Of Buying Pharmaceuticals Online. In the beginning of the new year, FDA will launch a new public education campaign about safe ways to purchase pharmaceutical products over the Internet. The campaign will include: placing advertisements on health related websites; taping public service announcements for distribution to television stations nationwide; and developing a "safety checklist" to be posted online and distributed through health care providers and consumer advocacy organizations.