Our firm has represented both doctors and and Web sites who are under investigation or have been charged with prescribing controlled substances via the Web.
The growing number of Web sites that offer consumers the opportunity to obtain prescription medications pursuant to an online medical consultation have been attracting considerable regulatory scrutiny from state and federal health officials.
For example, in Illinois, the Department of Professional Regulation suspended the license of Dr. Robert Filice for prescribing Viagra via an Internet pharmacy for patients he had never seen. Dr. Filice was working as a consultant for The Pill Box, a San Antonio, Texas-based pharmacy chain that sells online. The state suspended Dr. Filice’s license immediately because it determined his actions put people in danger. The agency later reinstated his license when he admitted that his conduct was “unprofessional.” The physician was fined $1,000, put on a two-year probation, and ordered to not prescribe medication to patients without personally interviewing and examining them.
Patients who wanted a prescription drug like Viagra logged onto The Pill Box’s site and filled out a health questionnaire. The completed form went to the company’s medical consultants, including Dr. Filice, who would reviewed the forms, and, if he found no health conditions that would preclude him from prescribing the drug, he would write a prescription for the drug, which the Pill Box would fill.
Many state legislators have passed or are considering bills to regulate online and mail-order pharmacies that sell products in the state. The laws would require Internet pharmacies to register with the state annually.
Recent enforcement actions in several other states highlighted below are indicative of this increased scrutiny at the state level:
• In Washington, the Board of Health fined an orthopedic surgeon $500 for engaging in “unprofessional conduct” by writing Viagra prescriptions for patients without performing a physical examination.
• In California, state regulators recently shut down two web sites-www.drpropecia.com and www.deyarmanmedical.com.com-run by a San Diego osteopath who was using the Web to prescribe baldness treatments without performing a traditional medical examination. The state is likely to fine the doctor, who has been practicing medicine for nearly a quarter-century, and could take away his license.
• In Kansas, the Attorney General on June 9 filed civil petitions alleging violations of consumer protection laws against seven companies that were selling prescription-only medications, including Viagra and weight-loss drugs, over the Internet. The Attorney General alleged that the companies violated a variety of state laws. Primarily, the alleged misdeeds stem from the distribution of prescription drugs by a doctor or pharmacist who was not licensed in the state. The state went after not only the sites that prescribe the medications, but also three pharmacies that filled the prescriptions. One of the suits alleges that Viagra was illegally dispensed to a 16-year old boy using his mother’s credit card. If found liable, the companies could face penalties of $5,000 to $10,000 per violation.
• In Missouri, the Attorney General obtained a temporary restraining order against an online Texas-based pharmacy and its owner blocking the site’s unlawful sale of prescription-only drugs to Missourians over the Internet. During a press conference, the Attorney General told reporters that the San Antonio pharmacy, S&H Drug Mart, and its owner, William A. Stallknecht, are violating Missouri law by providing prescription drugs to Missouri consumers without a state license and on the basis of information provided in online consultations.
• In Ohio, a family-practice doctor was recently charged with 64 offenses in connection with prescribing drugs including Viagra on the Internet. The prosecutor said this is the first Ohio doctor to be criminally charged after prescribing drugs over the Internet without seeing patients.
• In Maryland, a Baltimore doctor who gained notice by distributing diet pills over the Internet has been indicted and convicted on 34 federal charges accusing him of illegally prescribing medicine.
• In Nevada, the Board of Medical Examiners recently barred Internet sales of prescription medications unless Nevada doctors also see the patients.
• Colorado disciplined a doctor who supervises a cosmetic surgery clinic for engaging in unprofessional conduct by prescribing over the Internet.
• Wyoming recently ordered a Web site to stop selling in its state.
• Arizona has tried to stop out-of-state and overseas Internet doctors from doing business with state residents.
In addition to these recent state enforcement activities, the American Medical Association (AMA) has taken the position that online physicians who write prescriptions without patient contact are in direct violation of AMA policy. Starting in 2002, the AMA called on state medical societies, government regulators, and licensing boards to investigate doctors who dispense pills to patients without examining them. Noting that no state laws directly address the issue of online prescribing, the AMA said that it would assist the Federation of State Medical Boards (FSMB) in developing them. But in the absence of state law, the AMA says that local medical boards should take action against doctors who are prescribing drugs for patients they don’t know.
The AMA Board of Trustees report, which was adopted by the House of Delegates, directs the AMA to work with the FSMB, the National Association of Boards of Pharmacy, and the Food and Drug Administration to curtail inappropriate online prescribing. Recognizing the growing use of the Internet in health care, the AMA report considers online transmission of prescriptions, order refills, and electronic consults appropriate if the physician and patient have a preexisting relationship.
The National Association of Boards of Pharmacy (NABP), which represents state pharmaceutical licensing authorities, has also taken the position that any site that uses a questionnaire without a legitimate patient-physician relationship is illegal. NABP’s Executive Director Carmen Caltizone explains that pharmacies can only fill valid prescriptions, and prescriptions written by cyberdoctors are not valid. Therefore, he reasons, it is illegal for druggists to fill them.
The NABP also advocates licensing of online pharmacies in every state. To help guide consumers, the pharmacy association recently developed a voluntary seal program-called the NABP Verified Internet Pharmacy Practice Sites (VIPPS)-which will endorse sites that meet its criteria for dispensing drugs online. The NABP plan of voluntary seals has the endorsement and cooperation of the Drug Enforcement Agency, the Food and Drug Administration, and the AMA.
The online drug industry has also not gone unnoticed by Congress. In March, House Commerce Committee Chairman Bliley (R-VA), along with three Democratic Congressmen, asked the General Accounting Office (GAO) to address how online pharmacies prevent unqualified persons from receiving prescriptions and whether they are more susceptible to fraud or deception. The GAO has also been asked to examine the online doctor consultation which is viewed by some Congressmen as highly unethical and prone to serious problems.
In summary, this increased scrutiny of the online prescription drug business seems to be primarily focused on those sites that sell and prescribe medications without requiring a physician to physically examine a patient. Although reasonable arguments can be made that a physician’s face-to-face meeting with a patient may not be necessary with respect to certain drugs, the AMA, the NABP, and a number of state Attorney Generals do not agree. Accordingly, it is becoming increasingly risky to operate a site that prescribes medications without requiring a physician to conduct an in-person physical exam of a patient. With respect to those sites that only fill prescriptions sent to them by licensed physicians, officials appear to be focused on making certain that these sites are appropriately licensed in every state where they do business.