Karr Tuttle Attorney Published in ABA Health Law Section News
Karr Tuttle shareholder and regulatory compliance attorney Ron Friedman was published in the American Bar Association’s Health Law Section Newsletter this March with his article, “Importing Prescription Drugs Remains Risky Business Due to FDA and DEA Regulation.” As drug prices in the United States continue to escalate, providers and patients are seeking ways to lower prices, including by importing foreign drugs into the United States. In his article, Mr. Friedman weighs in on these issues and discusses the current legality of importing foreign prescription drugs into the U.S.
Below is an excerpt from the article:
Legality of Importing Prescription Drugs
While many medical providers, pharmacies, and individuals are no doubt attracted by the often lower prices of such drug products, and while these products may be of the same quality as domestic drugs, federal law generally prohibits the introduction of these drugs into the United States, unless: (a) the drug was manufactured by a foreign facility registered with the FDA and the foreign version of the drug is specifically FDA-approved, or (b) the drug was manufactured in the United States, is FDA-approved, and is being reintroduced into the United States by the original manufacturer. The legal risk is upon the sender of the drug as well as those involved in causing or facilitating its importation to ensure that the importation is lawful. If not, serious consequences may follow.
Friedman goes on to discuss the “enforcement discretion” U.S. Custom officials typically exercise to allow consumers with prescriptions to acquire their drugs from a foreign pharmacy and to allow those drugs into the country, which is differentiated from drugs being imported by pharmacies, physicians, and pharma distributors, where there is no such “enforcement discretion”, and the conduct is regarded as wholly illegal. Mr. Friedman provides advice regarding how to determine whether or not a drug is FDA-approved, and the criminal penalties associated with unlawful importation of foreign drugs.
In conclusion, Mr. Friedman comments: “While the government does not go after everyone for every offense committed, there is currently significant risk in acquiring drugs from a foreign country, especially where such drugs are intended for further distribution to others.” He warns healthcare entities and practitioners to avoid becoming involved in importing drugs, unless they can ensure that the drugs are FDA-approved and confident they are compliant with the law.
You can find the full article on the American Bar Association website, or by clicking here.
Ron Friedman (email@example.com) is a shareholder at Karr Tuttle Campbell, a Seattle-based law firm, focusing on regulatory compliance in the food and pharmacy sections. He has extensive experience working with the Food and Drug Administration, Drug Enforcement Administration and state boards of health and pharmacy. Prior to entering private practice, Ron served 22 years as a federal prosecutor for Seattle. Read his full bio here.