Progress in the challenge to regulate online pharmacies.

• Author: Karberg, Jeff

1. INTRODUCTION II. TYPES OF ONLINE PHARMACIES III. EXISTING LEGISLATION A. About the Regulatory Agencies B. An Analysis of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 1. Strengths of the Ryan Haight Act 2. DEA endorsement a. Transparency and Notice b. Striking a Balance Between State and Federal Authority 3. Where the Ryan Haight Act falls short a. Unnecessary Legislation b. Failure to Address Crucial Aspects of Online Pharmacies IV. RECOMMENDATIONS FOR FUTURE LEGISLATION A. Web Intermediaries B. Patient Privacy C. Foreign Pharmacies D. Lifestyle Drugs E. Drug Manufacturers V. WHY THE RYAN HAIGHT ACT WILL BE SUCCESSFUL A. Online Banking B. Increasing Role of the Internet VI. CONCLUSION I. INTRODUCTION

   Imagine for a moment that after borrowing a credit card, a teenager strolls down the block to the local pharmacy. At the pharmacy, a doctor is at the door waiting and willing to prescribe anything to anyone. After answering a few questions, the teenager receives his prescription, where he takes it to the drug counter and places an order for a dangerous amount of painkillers. Imagine further that the teenager develops an addiction to the drugs and purchases an increased dosage each visit until finally, the teen dies from an overdose from the easily obtained prescription drugs.

   The situation described above is drawn from a real event) Nearly the very same chain of events happened to seventeen year old Ryan Haight. The only difference was that Ryan never even had to leave his home. Ryan visited an online pharmacy and obtained a prescription from a doctor he had never met for drugs he did not need. Using his father's credit card, Ryan had the drugs delivered to his home. (2) Tragically, Ryan became addicted to the drugs and eventually died of an overdose at age eighteen. (3)

   Ryan's tragic story was preventable. There are ample barriers and regulations in place that would have prevented Ryan's death if he had tried to obtain the drugs at his local pharmacy rather than one he found online. (4) The need for the government to regulate online pharmacies is well documented, (5) yet the federal government has largely avoided any meaningful regulation until passing the Ryan Haight Online Pharmacy Consumer Protection Act in October of 2008. (6)

   The transition from brick and mortar storefronts into cyberspace has presented both opportunities and challenges. This is especially true for online pharmacies, where medicine and technology come together in a relatively new way. Online pharmacies present a unique challenge by creating a tension between providing inexpensive remote heath care and the safety of in person health care.

   The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 is the first federal bill passed specifically to regulate online pharmacies. In this note, I will identify the strengths and weaknesses of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the "Ryan Haight Act" or the "Act") and make suggestions for future online pharmacy legislation.

   Part II of this note provides background information about online pharmacies. Part III discusses the agencies responsible for online pharmacy regulation and explains existing federal regulation. In explaining the existing online pharmacy regulation, Part III of this note also identifies the strengths and weaknesses of the federal regulation. Part IV provides suggestions for future online pharmacy legislation. Part V of the note is a short explanation of how online pharmacies will be successfully regulated through federal registration. This note concludes that the current federal regulation of online pharmacies provides much needed progress but must be improved to ensure adequate protection.

2. TYPES OF ONLINE PHARMACIES

   Generally speaking, "[o]nline pharmacies are divided into three broad categories: traditional online pharmacy, prescribing-based site pharmacy, and rogue pharmacy." (7) The traditional pharmacies are little more than an online extension of brick and mortar pharmacies. (8) Often, this type of pharmacy is a nationally known or recognized chain. Traditional online pharmacies require a prescription before an order for medicine will be filled or delivered. (9)

   Traditional online pharmacies place value on consumer protection and have self-imposed standards that are commonly more protective than the regulations the Ryan Haight Act will put in place. CVS and Walgreens provide two well-known examples of traditional pharmacies. Traditional online pharmacies place value on consumer protection and have self-imposed standards that are more commonly more protective than the regulation that what the Ryan Haight Act will put in place. The National Association of Boards of Pharmacy, a non-government association that rates online pharmacies, developed the Verified Internet Pharmacy Practice Sites (VIPPS). (10) The VIPPS program was developed "[i]n response to public concern of the safety of pharmacy practices on the Internet." (11) Eligible online pharmacies display a seal prominently on the front page of their site after VIPPS accreditation. (12) To earn VIPPS accreditation, a pharmacy must "comply with the licensing and inspection requirements of their state and each state to which they dispense pharmaceuticals." (13) Furthermore, the pharmacies must demonstrate compliance with "VIPPS criteria including patient rights to privacy, authentication and security of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists." (14) Many of the VIPPS requirements go above and beyond the Ryan Haight Act's requirements for online pharmacies.

   A second category of online pharmacy, prescribing-based, is a remote consultation pharmacy. (15) This type of pharmacy will often provide both the prescription and the medication. (16) A customer obtains a prescription after filling out a short questionnaire that is subsequently reviewed by a doctor for approval. (17) Because the doctors are often affiliated with the pharmacy site, most of the prescriptions are approved. (18) Remote consultation pharmacies will be most affected by the Ryan Haight Act. (19)

   To some, remote consultation pharmacies are a legal gray area. (20) Under good faith operation, these pharmacies potentially offer consumers the most convenience, privacy, and savings. (21) A well-informed consumer would be able to address all of his or her pharmacy needs through one stop shopping. The problems associated with remote consultation pharmacies are potentially deadly when any of the parties involved act with malicious, negligent or improper motives. For example, the consumer may be self-diagnosing a serious medical problem incorrectly or may fill out the online questionnaire dishonestly. Or perhaps the doctor, who is often paid for each prescription dispensed, over-prescribes the patients so that he or she may make more money. Worse yet, the entire website may be a sham pharmacy designed simply to sell pills to addicts. The Ryan Haight Act will address many of these concerns in an attempt to clarify the government's stance on the legality of remote consultation pharmacies. (22)

   A third online pharmacy category is the "rogue pharmacy." (23) The defining characteristic of a rogue pharmacy is that medication is dispensed without a prescription. (24) Rogue pharmacies are considered extremely dangerous and are currently illegal. (25) Many of them operate from outside of the United States. (26) Rogue pharmacy customers are often the targets of fraud and counterfeit medicine. (27) There is little difference between this type of pharmacy and back alley drug dealers. (28)

   Although rogue pharmacies are a threat to the safety of internet pharmacy consumers, the government's stance on them is clear. When the government becomes aware of rogue pharmacies, they are shut down and the operators are prosecuted. (29) The Ryan Haight Act may have some effect on rogue pharmacies, particularly through the amendment that will increase the length of prison sentences for convicted parties. (30) However, the Ryan Haight Act will not substantively change the way consumer, the government, and rogue online pharmacies interact. (31)

3. EXISTING LEGISLATION

   1. About the Regulatory Agencies

      Online pharmacies face federal regulation primarily from the United States Food and Drug Administration (FDA) and the United States Drug Enforcement Administration (DEA). (32) Currently, the FDA regulates online pharmacies through the Federal Food, Drug, and Cosmetic Act (FD&C). (33) The DEA regulates online pharmacies through the Controlled Substances Act of 1974. (34) The agencies regulate different aspects of online pharmacies. The FDA tends to regulate non-controlled substances while the DEA regulates controlled substances. The two agencies often work together; for example, the "FDA assists DEA in deciding how stringent DEA controls should be on drugs that are medically accepted but that have a strong potential for abuse." (35)

      According to its mission statement, the FDA is "is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation." (36) The FDA officially came into existence after the Wiley Act was passed in 1906. (37) The Wiley Act placed the Bureau of Chemistry in charge of label regulation. (38) At its inception, and until 1912, the FDA was primarily focused on regulating food, rather than drug products. (39)

      The FD&C was first passed in 1938 after a series of tragic and needless deaths. (40) The FD&C "brought cosmetics and medical devices under control, and it required that drugs be labeled with adequate directions for safe use ... and mandated pre-market approval of all new drugs." (41) This meant that drugs needed FDA approval before manufactures...