Selling medicine over the Internet sometimes falls within telemedicine practice, but practitioners should beware of separate federal and state rules that address online prescribing.
The FDA is so concerned that it has issued a statement, Buying Medicines over the Internet (see below). Statement #13 below is particularly important. Our law firm gets many calls from clients who want to ship products from overseas (both pharmaceutical drugs and dietary supplements). It is important to understand that federal food and drug (FDA) laws do apply here.
Also on the federal side, telemedicine proponents must beware of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008.
This federal statute is named after a teenager who died of an overdose of controlled substances obtained over the Internet. The Ryan Haight Act regulates not only Internet pharmacies, but also the distribution over the Internet of controlled substances.
The Ryan Haight Act defines an "online pharmacy" as a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses a controlled substance by means of the Internet.
The Ryan Haight Act further imposes registration and reporting requirements on online pharmacies that dispense 100 or more prescriptions or 5,000 or more dosage units of all controlled substances combined in one month. An online pharmacy must: (1) display specified information on its Internet home page, including a statement that it complies with the requirements of the Ryan Haight Act, its name, address, and telephone number, the qualifications of its pharmacist-in-charge, and a certification of its registration under the Ryan Haight Act; (2) comply with state laws for the licensure of pharmacies in each state in which it operates or sells controlled substances; and (3) notify the Attorney General and applicable state boards of pharmacy 30 days prior to offering to sell, deliver, distribute, or dispense controlled substances over the Internet.
The online pharmacy must further prominently post the following statement:
This online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation or medical evaluation via telemedicine in accordance with applicable requirements of section 309 [of the federal Controlled Substances Act].
Notably, the Ryan Haight Act excludes from the definition of online pharmacies: (1) manufacturers or distributors who do not dispense controlled substances to an unregistered individual or entity; (2) nonpharmacy practitioners; (3) certain hospitals or medical facilities operated by the federal government or by an Indian tribe or tribal organization; (4) mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance; and (5) other persons or entities the exclusion of which the Attorney General and the Secretary of Health and Human Services find to be consistent with effective controls against diversion and with the public health and safety.
This language is a little tricky. It excludes physicians. However, it is important to be aware of the Ryan Haight Act as many telemedicine patients may ask about Internet pharmacies and physicians would not want to be in the position of aiding and abetting illegal activities. The Ryan Haight Act specifically prohibits aiding and abetting offenses involving dispensing of controlled substances by means of the Internet. Examples include knowingly or intentionally:
· writing a prescription for a controlled substance for the purpose of delivery, distribution, or dispensation by means of the Internet;
· serving as an agent, intermediary, or other entity that causes the Internet to be used to bring together a buyer and seller to engage in the dispensing of a controlled substance in a manner not authorized by the Ryan Haight Act; and
· offering to fill a prescription for a controlled substance based solely on a consumer’s completion of an online medical questionnaire.
It may be confusing when reading the Ryan Haight Act that it also explicitly addresses telemedicine as well as online pharmacies.
The Ryan Haight Act provides, among other things, that: “No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.” The term “valid prescription” means a prescription that is issued for a “legitimate medical purpose in the usual course of professional practice” by a practitioner who has conducted at least one in-person medical evaluation of a patient.
The Ryan Haight Act excludes from the above requirement, “the delivery, distribution, or dispensing of a controlled substance by a practitioner engaged in the practice of telemedicine.” In other words, practitioners who are engaged in the “practice of telemedicine” (as defined below) come under a different set of rules than online pharmacies and non-practitioners.
To understand this, we have to read further. The Ryan Haight Act defines the “practice of telemedicine” as:
the practice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, which practice—
(A) is being conducted—(i) while the patient is being treated by, and physically located in, a hospital or clinic registered under section 303(f) [of the federal Controlled Substances Act]; and (ii) by a practitioner—(I) acting in the usual course of professional practice; (II) acting in accordance with applicable State law; and (III) registered under section 303(f) [of the federal Controlled Substances Act] in the State in which the patient is located [unless designated exemptions apply]…. [or]
(B) is being conducted while the patient is being treated by, and in the physical presence of, a practitioner—(i) acting in the usual course of professional practice; (ii) acting in accordance with applicable State law; and (iii) registered under section 303(f) [of the federal Controlled Substances Act] in the State in which the patient is located [unless designated exemptions apply]…. [or]
(E) is being conducted by a practitioner who has obtained from the Attorney General a special registration under section 311(h)
In other words, a practitioner who is engaged in the “practice of telemedicine” must comply with one of the enumerated options.
For example, a California physician would be required to act in the usual course of professional practice, in accordance in the laws of California as well as the state in which the patient is located, and appropriately registered to dispense controlled substances within the state in which the patient is located.
Additionally, the language indicates that a face-to-face encounter is necessary, as the remote session is part of a “practice” where the patient “is being treated by, and in the physical presence of, a practitioner.” California law requires an in-person exam prior to prescribing; and the California Medical Board reads the Ryan Haight Act to require at least one in-person patient medical evaluation prior to the issuance of a prescription. According to the Board, the in-person medical evaluation does not in itself demonstrate that the prescription was issued for a legitimate medical purpose. Practitioners who violate the requirement that the prescription be valid may be criminally prosecuted under 21 U.S.C. §841(h).
The National Association of Boards of Pharmacy states that since 2009, the California Board has assessed $600 million in fines against pharmacies and pharmacists who, in association with Internet drug outlet operations, have dispensed medications based on invalid prescriptions that did not meet the requirements stipulated by California law.
The Ryan Haight Act authorizes the Attorney General to issue a special registration for telemedicine practitioners. The registration may be issued if the practitioner, upon application for such special registration—(A) demonstrates a legitimate need for the special registration; and (B) is registered under section 303(f) in the State in which the patient will be located when receiving the telemedicine treatment [unless the practitioner meets designated exemptions]. Practitioners who issue a prescription for a controlled substance under the authorization, to conduct telemedicine during a medical emergency, must report to the Secretary of Veterans Affairs the authorization of that emergency prescription.
It is important when seeking legal advice concerning telemedicine practices to find an experienced attorney who understands the implications of federal and state law involving online pharmacies as well. There are nuances between the various sets of laws and those legal nuances can make all the difference between legal compliance on one hand, and a costly regulatory investigation on the other.
From the FDA guidance:
Patients who buy prescription drugs from Websites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately prescribed medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs.
The current system of federal and state safeguards for protecting patients from the use of inappropriate or unsafe drugs has generally served the country well. These laws require that certain drugs be dispensed only with a valid prescription because they are not safe for use without the supervision of a licensed health care practitioner. Generally, before the practitioner issues a prescription for a drug the patient has never taken before, he or she must first examine the patient to determine the appropriate treatment. Subsequently, the patient receives the drug from a registered pharmacist working in a licensed pharmacy that meets state practice standards.
The Internet makes it easy for unscrupulous people to sell drugs to patients without these safeguards in place. A Website may appear to be associated with a legitimate pharmacy when in fact it is not. Websites that sell prescription drugs without a valid prescription deny consumers the protection provided by an examination conducted by a licensed practitioner.
Yes. Legitimate pharmacy sites on the Internet provide consumers with a convenient, private, way to obtain needed medications, sometimes at more affordable prices. The elderly and persons in remote areas can avoid the inconvenience of traveling to a store to purchase medications. Many reputable Internet pharmacies allow patients to consult with a licensed pharmacist from the privacy of their home. Moreover, Internet pharmacies can provide customers with written product information and references to other sources of information like the traditional storefront pharmacy. Finally, the increasing use of computer technology to transmit prescriptions from doctors to pharmacies is likely to reduce prescription errors.
The National Association of Boards of Pharmacy has identified approximately 200 domestic web sites that dispense prescription drugs but do not offer an online prescribing service. According to a recent Chicago Tribune article cited by the American Medical Association, there are at least 400 web sites that both dispense and offer a prescribing service — half of these sites are located in foreign countries. Some have estimated that the number of Websites selling prescription drugs may now be closer to 1,000. The number of Websites, however, fluctuates from day to day, and seems to be growing.
It is impossible to accurately quantify adverse event rates because FDA’s postmarketing surveillance system receives reports on only a relatively small percentage of all adverse events caused by drugs. However, as a result of postmarketing surveillance data collected by FDA, we know that the sale of unapproved drugs and the illegal sale of approved drugs over the Internet poses a serious public health risk. We know, for example, of many adverse events resulting from the use of the drug GBL and the date rape drug GHB, which are unapproved drugs sold illegally
over the Internet. FDA learned recently of a person who was harmed by the use of Viagra purchased from a Website without an examination by a healthcare professional. Unfortunately, the man had a family history of heart disease and died after taking the drug.
We also know of cases where people choose the Internet for treatment to avoid consulting a health care professional. These consumers, however, run the risk of purchasing inappropriate drugs or unknowingly purchasing counterfeit or sub-potent drugs.
We know that adverse events are under-reported and we know from history that tolerating the sale of unproven, fraudulent, or adulterated drugs results in harm to the public health. It is reasonable to expect that the illegal sale of drugs over the Internet and the number of resulting injuries will increase as sales on the Internet grow. Without clear and effective law enforcement, violators will have no reason to stop their illegal practices. Unless we begin to act now, unlawful conduct and the resulting harm to consumers most likely will increase.
Industry self-regulation has a role to play when applied to legitimate businesses. However, self-regulation is an insufficient mechanism to control illegal practices.
Unlike the traditional relationship between a patient and the patient’s health care professional, some online practitioners issue prescriptions in the absence of a physical examination or direct medical supervision. According to the American Medical Association, a health care professional who offers a prescription for a patient the practitioner has never seen before and based solely on an online questionnaire generally has not met the appropriate medical standard of care. As a result, patients may receive a drug that is inappropriate for them to use and may sacrifice the opportunity for a correct diagnosis or the identification of an underlying medical condition for which use of the prescription drug may be dangerous.
It is a violation of the Federal Food, Drug, and Cosmetic Act to dispense prescription drugs without a valid prescription. FDA will work with the states to determine the validity of online prescriptions and to bring enforcement actions under state law, federal law, or both, as appropriate. In addition, several state boards of medicine have ruled that such practice is medical misconduct and have fined and suspended the licenses of health care practitioners who have prescribed drugs in this manner.
Several states have taken or are contemplating taking action against illegitimate online sellers of prescription drugs. Fourteen states (Arizona, California, Colorado, Connecticut, Illinois, Michigan, Kansas, Nevada, New Jersey, Ohio, Texas, Washington, Wisconsin, and Wyoming) have already taken some action against physicians prescribing drugs over the Internet. Although most of these cases involve cease and desist orders, some states have assessed fines and are contemplating stiffer penalties. One state has issued a temporary restraining order against an Internet pharmacy selling drugs without a valid prescription.
FDA has been working with the National Association of Boards of Pharmacy, the Federation of State Medical Boards, and the National Association of Attorneys General to establish points of contact in all states specifically for Internet related problems. Both the FDA and NABP Websites have online reporting forms for consumers to use in referring complaints to the appropriate regulatory authorities.
FDA believes its activities will complement those of the White House working group and are consistent with the Administration’s July 1997 Framework for Global Electronic Commerce and the President’s November 1998 Memorandum on Successes and Further Work on Electronic Commerce. Effective consumer protection is necessary to foster legitimate electronic commerce. Because legitimate electronic commerce activities may involve the practice of medicine or the practice of pharmacy, FDA will work with state law enforcement and regulatory bodies to better define the boundaries of legitimate online practices. By reducing the availability of illegal and harmful products in the electronic commerce marketplace, FDA enforcement activities will increase consumer confidence in the Internet.
The World Health Organization is in the process of developing a guide entitled "Medical Products and the Internet." In addition to providing tips on finding reliable health and medical information on the Internet, it will provide advice on buying medical products online. FDA participated in the development of this guide.
As a general matter, it is illegal to import an unapproved drug into the U.S. However, under FDA’s personal importation policy, FDA has authorized its inspectors to use their enforcement discretion to allow U.S. residents to import certain products under certain limited conditions. Under this policy, FDA may allow a U.S. resident to bring into this country an unapproved drug for their personal use for a serious condition, if there has been no commercialization or promotion of the drug to U.S. residents.
It is illegal for anyone, including a foreign pharmacy, to ship prescription drugs that are not approved by FDA into the U.S. even though the drug may be legal to sell in that pharmacy’s country. Under the scheme that Congress established to ensure that drugs are safe and effective, drugs are tested and test results are thoroughly reviewed by FDA scientists. U.S. law also requires that products approved for sale in the United States have their formulation approved by FDA, be made in a plant registered with FDA, and be produced under quality standards enforced by FDA.
Prescription drugs available from a foreign pharmacy that are products that FDA has not approved; products with similar, but not identical formulations as FDA-approved products; products not made under the quality standards required by U.S. law or labeled according to U.S. requirements; or products not stored or distributed under the quality conditions required in the U.S. cannot be legally sold in the U.S.
Our attorneys’ legal advice includes both federal and state law, and we advise clients on how to minimize their legal exposure. "Don’t roll the dice, get legal advice!"
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