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Ericka L. Adler, JD, LLM has practiced in the area of regulatory and transactional healthcare law for more than 20 years. She represents physicians and other healthcare providers across the country in their day-to-day legal needs, including contract negotiations, sale transactions, and complex joint ventures. She also works with providers on a wide variety of compliance issues such as Stark Law, Anti-Kickback Statute, and HIPAA. Ericka has been writing for Physicians Practice since 2011.
Importing drugs that are not FDA approved can lead to severe civil and criminal penalties and poor patient care.
Over the past year, I have received several calls from clients who received unexpected visits from FDA agents seeking information concerning the purchase of prescription drugs. In each case, the client had acquired expensive medications from a U.S. business at a fraction of the cost. The medications appeared identical in every way and there were no observed issues with any patients in the use of the medications. Sounds like an ideal way to cut costs, right?
What these physicians did not know (or did not want to know) was that the U.S. supplier was actually acquiring the medications from abroad, typically Canada and Ireland. Many physicians across the country have similarly looked to online pharmacies located outside the U.S. to acquire drugs at a cost of up to 50 percent less than the equivalent drugs available in the U.S. So what’s the problem? Importing drugs that are not approved by the FDA, even if they appear to be identical, is illegal and can lead to severe civil and criminal penalties.
In addition to legal considerations, when purchasing drugs from abroad, safety is also a great concern. Last year, the FDA investigated physicians who believed they had purchased the cancer drug Avastin from a Canadian online pharmacy, only to find out the imported medication contained cornstarch and acetone, but no active cancer fighting ingredients. Patients who received the false medication did not receive the cancer-fighting medications they truly required. Imagine the devastation of physicians who thought they were merely saving money and never intended to harm a patient.
Not only are the potential risks to patients severe, but the legal issues associated with importing foreign prescriptions can also be devastating. Importing unapproved drugs is a violation of the Federal Food, Drug, and Cosmetic Act (FDCA), which could result in civil or criminal penalties. For example, a first offense involving importation of a drug without applicable FDA approval can result in a year in prison or a fine of up to $1,000, or both. A second offense or a finding that that the importation was committed with the intent to defraud or mislead is a felony offense punishable by up to three years of imprisonment or up to a $10,000 fine, or both.
Additional penalties may also be imposed by a physician’s state medical board. For instance, under the Illinois Medical Practice Act a violation of any federal law or regulation regulating controlled substances constitutes unprofessional conduct. Thus, physicians can face suspension or revocation of their license and additional monetary penalties.
If you are a physician, you should simply ignore the multitude of faxes, emails, and pamphlets you receive from non-U.S. pharmacies selling brand-name drugs. In 2012 alone, the FDA issued five alerts discussing counterfeit medications, coming into the U.S. from foreign suppliers, and it has begun posting on its website the names of those physicians and practices it believes to be importing certain unapproved medications. A visit to your office is only the next step.
Additionally, be wary of U.S. companies that appear to offer name-brand medications at large discounts. Often these companies merely import drugs from abroad and resell to U.S. physicians who often don’t ask about the source of the drugs. Make sure you ask questions whenever something seems “too good to be true.”
Finally, I’ve stated this before, but if an investigator of any agency ever visits you, whether it’s the FDA, the FBI, the OIG, or any other office, call your legal counsel immediately! Unless you are presented with a subpoena, do not allow anyone to interview staff or search your office. Physicians can be cooperative and compliant without having to answer questions on the spot. You have the right to review your records and to talk with counsel, regardless of pressure tactics used to convince you otherwise. Make sure your staff is familiar with your policies on responding to questions from third parties about internal practice matters.