Drug Topics - December 1, 2008 - (Page 3) Regulatory & Law CONTROLLED SUBSTANCES ACT Fred Gebhart, Contributing Editor Federal rules squeeze illicit online Rx sales New federal rules restricting illicit online sales of controlled substances are having a quick impact. The rule doesn’t take effect until April 2009, but Web site registrars and Web hosting companies began applying the new rules soon after they were signed into law in October. “Heretofore, there was nothing we could do about rogue drug Web sites,” Christine Jones, general counsel of Go Daddy, the world’s largest Web site registrar, said. “It was clear that they were selling controlled substances without a prescription, without a physician, without checking anything except your ability to pay. We were looking for a tool to help us deal with them and now we have it.” The law, sponsored by Sens. Diane Feinstein (D-CA) and Jeff Sessions (R-AB), was named for Ryan Haight, a California teen who died in 2001 from an overdse from Vicodin bought online. Provisions amend the federal Controlled Substances Act, targeting Web sites that sell Christine Jones, general counsel of Go Daddy.com. these drugs without a physician examination and a valid script. Under the new provisions, online sellers must follow the same rules that restrict brick and mortar sales of controlled substances, Harry Hagel, senior vice president for government and professional affairs at the American Pharmacists Association, said. “The goal was to reduce access to controlled substances by teens and others who do not have a prescription,” Hagel said. “It doesn’t penalize legitimate pharmacies that have an online presence, and it isn’t going to impact legitimate medication access. But trying to circumvent the prescriber-patient relationship and the prescription process will be that much harder with these provisions.” APhA supported the act, as did the National Association of Chain Drug Stores and the National Community Pharmacists Association. Pharmacy groups backed the first-ever federal definition of a valid prescription for a controlled substance. The new definition requires a legitimate medical purpose for the script and a prescriber who has made at least one inperson medical evaluation of the patient. Online drug sellers have evaded prosecution in the past because there was no explicit definition of what constitutes a valid electronic prescription. “That provision closes a perceived loophole” that has W W W.D R U GTO P I C S .C O M hindered prosecutors in the past, Carmen Catizone, executive director of the National Association of Boards of Pharmacy, said. “There is no longer any confusion as to what is or is not a valid prescription.” Telemedicine practitioners are exempt from the new provisions. So are brick-and-mortar pharmacies such as independent and chain stores that are already subject to similar provisions under existing pharmacy law. Other key provisions require online sellers to comply with all state regulations and Board of Pharmacy rules in every state they do business. Online-only sellers must also obtain a specific Drug Enforcement Administration endorsement and disclose their physical address on their Web site. Go Daddy expects to use the new provisions to shut down about 9,000 drug Web sites by the end of the year, Jones said. That’s up from 1,300 drug sites the registrar closed in 2007 and 6,000 closed during the first half of 2008. Before the new provisions were signed into law, Jones said, registrars and Web site hosts could take action against Web sites only on the basis of federal court injunctions or customer complaints about spam or other abuse. Catizone said NABP’s only complaint is that the new law applies only to controlled substances instead of to all online Rx sales. The new law should help reduce illicit sales of Schedule II through V analgesics, steroids, and other drugs. But it does nothing to affect the illicit sales of Rx drugs for sexual performance, hair growth, and other lifestyle uses. “NABP would like to see the same controls imposed on all Rx drug sales,” Catizone said. “There would be no impact on legitimate pharmacy retailers because they already operate under these kinds of rules.” Until now, she explained, there has been no list of legitimate online drug sellers. NAPB had its list of verified internet pharmacy practice sites (VIPPS) online retailers, but only 15 pharmacies joined the program. Current VIPPS retailers include Caremark, DrugSource, Drugstore.com, Familymeds.com, CVS, Liberty Medical Supply, Medco Health Solutions, Prescription Solutions, Prime Therapeutics, Rx Direct, Savon.com, Tel-Drug, Walgreens, WellDyneRx, and WellPointNextRx. D E C . 1, 2008 PHOTO COURTESY OF GO DADDY.COM. DRUG TOPICS 3 http://www.Daddy.com http://WWW.DRUGTOPICS.COM
Table of Contents Feed for the Digital Edition of Drug Topics - December 1, 2008 Drug Topics - December 1, 2008 Federal Rules Squeeze Illicit Online Rx Sales CMS Issues Final Rule on Multisource Drugs Drug Topics - December 1, 2008 Drug Topics - December 1, 2008 - Drug Topics - December 1, 2008 (Page 1) Drug Topics - December 1, 2008 - Drug Topics - December 1, 2008 (Page 2) Drug Topics - December 1, 2008 - Federal Rules Squeeze Illicit Online Rx Sales (Page 3) Drug Topics - December 1, 2008 - CMS Issues Final Rule on Multisource Drugs (Page 4)
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.