CONTROLLING INTERNET Rx

December 28, 1999
		The White House proposes tighter controls over Internet sites that sell prescription drugs. Following a background report, Susan Dentzer discusses the proposed regulations with Gwen Ifill. The Health Unit is a partnership with the Henry J. Kaiser Family Foundation.

Focus: Internet Rx Dec. 28, 1999: Update: Internet Rx Regulations Dec. 27, 1999: Taxing E-Commerce Nov. 17, 1999: Background on the InternetRx issue Small Pharmacies: In on the Act. Nov. 17, 1999: RealAudio extended excerpts with: Ron Klink, Carla Stovall and Eric Thom. Browse the NewsHour's coverage of health.   White House Federal Drug Administration FDA testimony on e-pharmacies National Association of Boards of Pharmacy	GWEN IFILL: For more on today's proposal, I'm joined now by Susan Dentzer. So, Susan, it was only inevitable that the federal government was going to have to get involved in this. Exactly what would the announcement that was made today accomplish?
	Protecting the consumer
	SUSAN DENTZER: In effect, Gwen, what the president is proposing to do is two things -- arm consumers to police the Internet better themselves and to raise the level of armament in the hands of the federal government. As far as consumers go, in effect, what would happen is that the federal government would create a new seal of approval that would be on every Web site that was complying with existing state and federal statutes in the realm of drug prescriptions so that as a consumer you would be able to know that you were dealing with a site that was legitimate. In effect what they would do is build on an existing form of seal of approval that's been put together by a group of state pharmacy licensing boards called the VIPPS, the Verified Internet Practice Pharmacy Site. Essentially what the government will do is simply take over that seal of approval and in effect this site would become the federal -- in effect the VIPPS seal of approval would be the federal seal of approval. So consumers would know it was a legitimate site. Then in addition to that, the government is proposing that the FDA, the Food and Drug Administration, be granted an additional $10 million in fiscal 2001 to step up its own policing efforts and in particular to acquire new personnel, up to 100 individuals, who would be charged with overseeing illegal sites. That's up from about 10 at present. So it's a dramatic increase. And in addition they'd also be able to access some new technology. Finally, of course, is what we discussed earlier in the piece which is new financial penalties. At this point, according to the federal statute, at best if a site is violating federal law when it comes to drug prescribing, the most the government can do is stock it with a $1,000 penalty. This would increase the penalties to half a million dollars per violation.
	Tougher penalties
	GWEN IFILL: But in 50 states there are rules which are being violated everyday now. How would a federal seal of approval make a difference? SUSAN DENTZER: It would essentially just put consumers on notice that if they were not dealing ... or dealing with a site that did not have the seal of approval, the likelihood was very high that they were dealing with a site that is not in compliance with the law. The states do have these existing licensing requirements, as you point out. The problem is now that as you have Internet commerce taking place between and among states, it's very hard for the state authorities to police that and to enforce that as in the case of in our piece when we had violations of consumers obtaining drugs in Kansas. Usually those sites were not in Kansas, it was difficult for the state attorney general to crack down. GWEN IFILL: You were talking about the horror stories, the 16-year-old who were able to get Viagra, other people who were able to get prescriptions sight unseen basically by a doctor -- how exactly would this stop that or is this just a way of putting people on notice? SUSAN DENTZER: It's a way of putting people on notice and essentially beefing up existing ability to enforce the law. If a site knows that the most it can incur now is maybe a $5,000 penalty from the state, maybe at best $1,000 penalty from the federal government, there's obvious incentive given the market out there to keep doing what you're doing illegally. If, in fact, the penalties are going to be much larger, in fact, consumers are going to be put on notice that they ought not to be dealing with you unless you have that seal of approval. It will be a lot tougher for the illegal sites to operate. GWEN IFILL: What's to stop an illegal site from simply moving its operations offshore to the Bahamas or someplace and continuing to sell and not be subject to U.S. law? SUSAN DENTZER: Nothing is stopping the sites from doing that and, indeed, the FDA is well aware that that could be one unintended consequence of increasing regulation here in the U.S. The fact remains, though, that there are plenty of sites operating offshore as it is now and one of the great problems with the regulations that are being proposed now that they would do virtually nothing to deal with the growing problem of offshore prescribing. In fact, the FDA is now looking at other means to deal with that which may involve more screening of shipments of illegal drugs into the U.S. -- it may involve more partnering with foreign regulatory agencies to try to prosecute sites that are prescribing illegally, but that's a big problem and it is, indeed, one that might grow bigger as a consequence of this but it's going to be big no matter what happens.
	Regulating e-pharmacies
	GWEN IFILL: Is there any concern in the Internet industry that this constitutes an unwarranted federal intrusion into free marketing? SUSAN DENTZER: There hasn't been much comment to that effect yet mainly because people recognize that the federal government has, for more than 50 years, had a very strong role in drug policy, in pharmaceutical drug policy. We decided again more than 50 years ago that drugs had a lot of benefits to them but they also had a lot of risks, that they needed to be certified by the federal government, that there needed to be safety and effectiveness testing before they were brought out and, in fact, that once drugs were prescribed they had to be prescribed by physicians who were licensed in individual states and also sold through licensed pharmacies in individual states. What people are saying now is if these rogue sites continue to operate, you might as well throw that entire federal and state regulatory apparatus in the junk pile because if it can't prevent drugs from being sold illegally and even if some cases unapproved drugs from being sold illegally to people, again, we might not as well have had this marvelous regulatory system that has been created over the last five decades that has worked fairly well in the past. GWEN IFILL: You just touched on three things that make e-pharmacy shopping so much different from other kinds of Internet shopping and that's that there's a confidentiality concern, a licensing concern, and a liability concern for people who are actually selling these drugs. Is this a slippery slope that we've entered on to, this sort of being able to get prescription medication online? SUSAN DENTZER: I think it's a boon when it's done illegally as Commissioner Henney pointed out in our taped piece for people who are disabled, who live in rural areas, to be able to go online, get a legitimate prescription filled and delivered to your door in the space of a day is a fantastic benefit and is probably going to increase overall health of many Americans. The issue here is sites that are not playing by the existing rules, they're not playing by the rules that we've already got in place and the Internet gives them an ability to do that in a much more convenient -- for them -- way and that's really what all of this initiative is targeted at. GWEN IFILL: And the Internet makes it much more difficult to enforce in any kind of realistic way as well. SUSAN DENTZER: Absolutely right. GWEN IFILL: Susan Dentzer, thank you very much. SUSAN DENTZER: Thanks, Gwen.