Congress Passes Ryan Haight Online Pharmacy
OCT 01 -- ( WASHINGTON) – DEA Acting Administrator Michele M. Leonhart today hailed Congressional passage of the Ryan Haight Online Pharmacy Consumer Protection Act of 2007, which addresses the problems of online prescription drug trafficking, abuse, and availability.
“Cyber-criminals illegally peddling controlled substances over the Internet have invaded households and threatened America’s youth for far too long by supplying pharmaceuticals with a few clicks of a mouse and a credit card number,” Acting Administrator Leonhart said. “This landmark piece of legislation will bring rogue pharmacy operators out of the shadows by establishing a clear standard for legitimate online pharmaceutical sales. The legislation will allow customers to know they are doing business with a trusted, legitimate pharmacy, and give law enforcement the tools we need to identify illegitimate online pharmacies."
This legislation amends the Controlled Substances Act (CSA) in the following key respects:
1. Face-to-face requirement for prescribing: The Act prohibits dispensing controlled substances via the Internet without a “valid prescription.” For a prescription to be valid, it must be issued for a legitimate medical purpose in the usual course of professional practice, meaning that, with limited exceptions, a doctor must conduct at least one in-person medical evaluation of the patient.
This provision would address the primary harm caused by rogue Internet pharmacies: dispensing controlled substances on a large scale without a legitimate medical purpose. Rogue Internet pharmacies typically operate with active participation of an unscrupulous doctor who willingly issues prescriptions to “patients” throughout the country whom the doctor never sees and without a preexisting bona fide doctor-patient relationship.
2. Endorsement requirement: The Act requires an endorsement from DEA before a pharmacy could dispense controlled substances via the Internet. This endorsement would supplement the existing registration a pharmacy holds for its brick-and-mortar operation, and allow law enforcement to clearly identify internet sites where controlled substances can be sold.
Currently, domestic rogue Internet pharmacies are generally supplied by DEA-registered brick-and-mortar pharmacies. Typically, these brick-and-mortar pharmacies have little or no walk-in customers and do most or all of their business via rogue Internet sites. In some instances, criminal organizations find legitimate “mom and pop” brick-and-mortar pharmacies and purchase them, then use them for just a few months as a supplier to rogue Internet operations, then walk away from the pharmacy after taking in substantial cash.
Rather than try to block all online pharmaceutical sales, the Ryan Haight Act will put online pharmaceutical sales on an equal regulatory footing with those sales through a brick-and-mortar facility. The act requires an endorsement of an existing registration to allow existing pharmacies to sell controlled substances online. This means law enforcement will be able to carefully scrutinize all applications for such registration and be able to easily separate legitimate and illegitimate Internet operations.
3. Enhanced penalties for schedule III through V: The Ryan Haight Act will enhance penalties for unlawfully dispensing controlled substances in schedules III through V. These enhanced penalties would apply equally to all unlawful distributors and dispensers of controlled substances (not just those who do so by means of the Internet).
Criminals are aware of the low penalties associated with Schedule III and Schedule IV substances, and generally refrain from selling schedule II substances. Hence, to provide a credible deterrent where illicit distribution is most prominent, the Act increases the statutory maximum penalties applicable to the illegal distribution of Schedule III and IV controlled substances as follows:
These changes to maximum penalties apply to all illegal distributions, not just those occurring over the internet.
4. Prohibition on advertising illegal sales: The Ryan Haight Act will make it a crime to use the Internet to advertise the illegal sale of a controlled substance by means of the Internet.
5. Requirement that Internet pharmacies post certain information on their Web sites: The Ryan Haight Act will require online pharmacies to post truthful information about their location, identity, and licensure of the pharmacy, pharmacists and prescribers, and states in which they are authorized to practice pharmacy.
This provision would assist law enforcement in investigating online pharmacies and should also provide some deterrent against noncompliance (by reminding online pharmacies of their legal duties).
6. State Cause of Action: The Ryan Haight Act will give the Attorney General of each state the ability to bring a civil action in a federal district court to enjoin the actions of an online pharmacy or person which/who is operating in violation of this statute. To bring such an action, the state must have served prior written notice on the Attorney General of the United States, giving the Attorney General the opportunity to intervene in the litigation.
This provision would help ensure that state and federal enforcement authorities can work in partnership with each other and that individual states are able to take effective enforcement action. Under current law, a state Attorney General’s enforcement authority against an online pharmacy is limited to the geographic boundaries of that state, which causes significant challenges when a case involves illegal activity over the Internet.