A New Legal Weapon in Combating Prescription Drug Diversion

Judy McKee, End of Life Healthcare Counsel and Nick Alexander, Criminal Law Counsel

Judy McKee, Project Coordinator and Counsel, End of Life Health Care

On Oct. 15, President Bush signed into law H.R. 6353, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Public Law No. 110-425) [1]. The legislation responds to the heightened concern regarding the ease of purchasing controlled drugs without a legitimate prescription over the Internet. The new law, which takes effect in April 2009, is named after an 18-year old California resident who died after taking Vicodin purchased from an online pharmacy without his ever seeing or talking with a doctor. By amending the federal Controlled Substances Act (21 U.S.C. Â 801, et seq.),[2] Congress has given both federal and state law enforcement personnel additional tools with which to address prescription drug diversion and abuse.

The National Center on Addiction and Substance Abuse at Columbia University (CASA)[3] has been chronicling the rise of Internet pharmacies since 2004 when it issued its first, report, â?œ‘You’ve Got Drugs:’ Prescription Drug Pushers on the Internet.” Its latest report, issued in July 2008, identified 365 sites, 206 of which were advertising prescription drugs and 159 were offering these drugs for sale. Of the 159, only 2 were certified by the National Association of Boards of Pharmacy as legitimate Internet pharmacy sites. Several states have already passed their own legislation addressing the sales of prescription drugs on the Internet[4], including Arkansas, Idaho, Indiana, Kentucky, Louisiana, Texas and Wisconsin. Many of these statutes require registration and specific disclosure requirements. Others require an in-person medical examination in order for a prescription to be valid or ban online consultations.

The primary requirement under the new statute is that no controlled substances may be sold over the Internet without a valid prescription. In order for a prescription to be valid, it must have been issued for a legitimate medical purpose in the usual course of professional practice after at least one face-to-face medical evaluation of the patient. A â?œcovering practitioner” may also issue a prescription if the practitioner who has conducted the in-person physical exam is temporarily unavailable.

While the new law protects lawful retail drug chains that have online Web sites to fill customers’ request for refill on their legitimate prescriptions, there are stringent registration requirements. The act requires each pharmacy dispensing controlled substances via the Internet to be registered by each state in which it operates or sells controlled substances and to modify its existing Drug Enforcement Administration (DEA) registration to include the authority to dispense controlled substances in this manner. By requiring traditional pharmacies, often called â?œbrick and mortar” pharmacies, to specifically require registration to dispense via the Internet, the DEA will be able to scrutinize each application to determine whether a rogue Internet site is involved in the operation. DEA has found that many of these rogue Internet pharmacies are supplied by traditional DEA-registered pharmacies. According to the agency, some enterprises have purchased brick and mortar pharmacies, operated them under the existing DEA registration as a supplier to a rogue Internet operation, and then walked away, beginning its operation in another location.

The Ryan Haight Act also requires specified information to be posted on the pharmacies’ Web sites, including the states in which they are authorized to sell medicines, where they are located, the pharmacists and prescribers they are associated with, and other identifiers. The act makes it a crime to use the Internet to advertise illegal sales of controlled substances on the Internet. The pharmacies also must report to the U.S. Attorney General the total quantity of each controlled substance it dispenses in a month if they have sold above a certain threshold.

To combat the increased illegal sales of Schedule III, IV, and V drugs over the Internet, the new law increases maximum sentences for the illegal sale of drugs in these schedules and increases the penalties further where death or serious bodily injury results. For instance, the penalty for illegally selling Schedule III drugs, including anabolic steroids which have been the subject of recent news reports and congressional investigations, has been increased to up to 10 years or up to 15 years where serious bodily injury or death has occurred.

Of particular interest to the states, the law gives the Attorney General of each state the ability to bring a civil action in federal district court, after notice to the U.S. Attorney General, to enjoin the actions of any Internet pharmacy that is violating the statute and to collect damages and other compensation, including civil penalties, where the actions have threatened or have adversely affected a state resident. This provision allows state Attorneys General to shut down rogue pharmacy operations nationally, not just within the borders of their own state. The law specifically states that each state’s Attorney General may exercise all powers conferred by their respective states regarding discovery and other investigatory techniques.

Exemptions

There are some exemptions found in the legislation. The new law specifically exempts telemedicine practitioners, licensed by the state in which the patient resides, when the patient is being treated by, and physically located in, a registered hospital or clinic and where the practitioner is acting in the usual course of professional, and in accordance with state practice. This exemption also generally applies to telemedicine practitioners acting under the auspices of the Department of Veterans Affairs or the Indian Health Services. Department of Defense hospitals and medical facilities and their agents and employees are also generally exempt from the statute’s provisions. In addition, the act provides exemptions for public health and medical emergencies.

The CASA reports emphasize that legislation which affects only rogue sites operated from within the United States will address just a portion of the problem. CASA advocates that the State Department negotiate treaties with foreign governments to help shut down Internet trafficking of controlled prescription drugs internationally. While the new legislation does not include this requirement, it does mandate that the DEA report to Congress, after consultation with the State Department, regarding the foreign supply chains that are offering controlled substances for sale without a valid prescription. This report is also to detail the steps DEA is taking to address these sources and how the agency is working with domestic and multinational pharmaceutical companies to build cooperation in the effort to halt sales. The first report is due April 2009, the effective date of most of the provisions of the act.

According to CASA and other experts, there are additional steps that could be taken. For instance, federal and state enforcement officials could work with credit card companies and financial institutions to encourage more strict scrutiny in processing payments. According to Philip Heymann, a deputy attorney general during the Clinton administration and currently professor at Harvard University Law School, Congress could create a private or government-run group responsible for identifying rogue pharmacies and, then, under current anti-money laundering statutes, domestic financial institutions could then decline U.S.-based transactions for rogue pharmacies overseas.[5] Search engines, such as Google, Yahoo and MSN/Windows Live Search, now partially depend on a verification program called PharmacyChecker to screen out rogue pharmacies, but the system does not seem to be working very well. Cooperative agreements among the states, the federal government, and search engines that appear to be profiting from advertisements of controlled prescription drugs online could be crafted, similar to those that the state Attorneys General have negotiated recently with Craigslist, Facebook and MySpace.

There are indications that the new law is already beginning to impact the Web. According to USA Today,[6] the popular Web-hosting company GoDaddy.com has already shut down dozens of sites that sell anabolic steroids and human growth hormones. Other hosting and registrar companies, including Register.com and Hosting.com, are moving in the same direction. General counsels of these companies cite the new law as giving them the legal backing to take the sites down even though the law won’t go into effect until April.

While there will always be those who object to any legislation which curtails the ability of consumers to purchase medications through the Internet, supporters of this new legislation argue that it attempts to strike a balance between ensuring that consumers can purchase needed and prescribed medication online and protecting others, particularly teenagers and young adults, from the seductive lure of purchasing controlled substances over the Internet.


[1]http://www.govtrack.us/congress/billtext.xpd?bill=h110-6353.

[2] The Controlled Substances Act (CSA), Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, provides the legal foundation for federal efforts to stem the abuse of drugs and other substances. The statute places all substances regulated under existing federal law into one of five schedules, based on a substance’s potential for abuse and medical usefulness.

[3]http://www.casacolumbia.org/

[4] See â?œYou’ve Got Drugs!: Prescription Drug Pushers on the Internet,” A CASA White Paper (July 2008), available at http://www.casacolumbia.org/ViewProduct.aspx?PRODUCTID=756e24b7-5db0-4433-acb2-115a59b78894, nn. 31-39.

[5] See Brian Krebs, â?œ‘Rogue’ Internet Pharmacies Fueling Drug Abuse,” available at http://www.nascsa.org/News/roguepharmacies5.07.pdf. See also Mathea Falco and Philip Heymann, Fighting the Online Drug Cancer, Wash.Post, Mar. 15, 2008, at A13.

[6] A.J. Perez, New Law Allows Website Hosts to Just Say No to Drugs, USA Today, Oct. 25, 2008, available at http://www.usatoday.com/sports/2008-10-23-online-pharmacies-get-boot_N.htm.

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