Clinton Administration Announces Initiative to Regulate Online Sale of Prescription Drugs

(December 29, 1999) The Clinton Administration announced on December 28 a set of proposals to stem the illegal sale of pharmaceuticals over the Internet. The initiative would expand the Food and Drug Administration's regulatory authority in this area.

See, White House Press Release, 12/28/99.

A statement released by the White House described the situation. "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."

In a related matter, the FDA reported on December 28 that there are "no significant Y2K related problems with the nation's supply of pharmaceuticals."

The administration proposal would vastly increase the authority of the Food and Drug Administration. It would:

See, Testimony by Janet Woodcock, 7/30/99.

An FDA representative testified on this topic to the House Commerce Committee last summer. "In the context of prescription drug sales over the Internet, government should encourage private sector leadership in achieving a safe marketplace," said Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research. "Government should refrain from imposing any unnecessary regulations, but should protect consumer health and safety through effective enforcement of existing law on illegal drug sales."

The House Commerce Committee's Subcommittee on Oversight and Investigations held a hearing on July 30, 1999 entitled "Drugstores on the Net: The Benefits and Risks of Online Pharmacies."

Rep. Tom Bliley (R-VA), Chairman of the House Commerce Committee, made a statement about online drug sales. He stated that "Millions of Americans are dependent on prescription medication. On-line pharmacies have the potential to increase access and lower the cost of prescription drugs for millions of Americans."

"However, we must not be blind to the vast potential of the Internet to attract unscrupulous operators, who set up sites to sell their wares, without the best interest or safety of consumers in mind," continued Rep. Bliley. "At the same time, it is important that we do not over react by piling layers of new regulations on to an emerging marketplace."

Rep. Fred Upton (R-MI), who chaired the hearing, stated that "In my home district of Kalamazoo, Michigan, a local news station was able to order Viagra for a cat, a dog, a deceased individual, and a man with a heart condition. The ease at which these transactions happened was alarming. These unscrupulous sites pose a threat to the health and safety of the American public and undermine the public's confidence in legitimate on-line pharmacies."

There is a bill pending in the House of Representatives to deal with online drug sales. However, it is much different from the administration proposal.

HR 2763 IH, sponsored by Rep. Ron Klink (D-PA), would require that web sites that are used for the sale of prescription drugs disclose certain information.

Under this bill, the web site involved in the sale of prescription drugs must disclose the name, business address, and telephone number of the person selling the prescription drugs. It must also list each state in which such person is authorized by law to dispense prescription drugs. It must also name each individual pharmacist, and the states in which they are licensed. Finally, if medical consultations are provided through the web site, the disclosure must also include the names of the individuals providing consultations, the states in which they are licensed, and licenses which they hold.

The bill would leave primary enforcement authority to the states, not the FDA.

Statement by Rep. Tom Bliley (R-VA).
Re: E-commerce and the sale of prescription drugs.
Date: July 30, 1999.
Source: House Commerce Committee.
Today, this committee continues the work it began last year, examining various aspects of doing business on the Internet - known as e-commerce.

I have been a strong advocate and promoter of the consumer benefits of electronic commerce. This marketplace grows by leaps and bounds every month, revolutionizing the way America and the world conduct business.

As e-commerce continues its extraordinary growth, it can greatly improve the lives of ordinary Americans. This is especially true when it comes to the delivery of necessary prescription medication. Millions of Americans are dependent on prescription medication. On-line pharmacies have the potential to increase access and lower the cost of prescription drugs for millions of Americans.

In an age in which the words 'time deficit' have entered the popular vocabulary, the ability to have necessary prescriptions delivered to the front door by overnight delivery, and at a real cost savings, is a tremendous convenience for time-pressed working families.

For the disabled and for the millions of senior citizens who have difficulty getting around, this new marketplace has the potential to drastically improve their access to medications, and thus their quality of life.

However, we must not be blind to the vast potential of the Internet to attract unscrupulous operators, who set up sites to sell their wares, without the best interest or safety of consumers in mind. Many web sites are offering prescription drugs prescribed by an unseen on-line doctor or without even a prescription. Many of these sites give no indication of their location or the individuals operating it, raising concerns about the legitimacy of the web site. Because of their slick packaging, many of these sites fool consumers into believing that they are legitimate providers, when in fact they are unlicensed to dispense drugs or do so in ways that violate state or federal laws.

I want to stamp out these bad actors. We need to encourage strong enforcement action by the States and the Federal government of the laws already on the books. Some states, such as Kansas, take action against on-line pharmacies and web doctors who have violated the laws of their respective states. Several other States are beginning to follow the lead of Kansas to shut down these sites. We applaud their efforts.

Additionally, I believe that the Federal and State governments must work together to address illegal or unscrupulous practices by on-line pharmacies. I suggest the establishment of a joint Federal-State task force to examine whether current laws and regulations are adequate to protect purchasers of drugs on the Internet -- and if not to recommend changes to those laws.

At the same time, it is important that we do not over react by piling layers of new regulations on to an emerging marketplace - one that provides great benefits to consumers. I am excited about the promise this new marketplace brings to working families, the disabled, and senior citizens across the country. Let's continue our oversight of this new marketplace, to ensure that its promise is fulfilled in a way that also protects on-line purchasers. I would like to thank all of our witnesses for joining us here today.