Pharmaceutical Watchdogs Sue FDA/HHS to Enjoin New Safety Standards for Canadian Prescription Drug Imports

On Monday, a group of pharmaceutical watchdogs brought suit in the District Court for the District of Columbia seeking to enjoin a newly implemented final regulation from the Department of Health and Human Services (DHHS) and the Food & Drug Administration (FDA) concerning the importation of prescription drugs from Canada. The plaintiffs alleged that the final rule removed existing drug safety requirements for imports in violation of the statute delegating the defendants’ power to create importation standards for prescription drugs. 

The plaintiffs averred that the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes the defendants to develop regulations that govern the importation of prescription drugs made in Canada if the regulations “pose no additional risk to the public’s health and safety” and “result in a significant reduction in the cost…of prescriptions to the American consumer.” The watchdogs asserted that the defendants’ regulations failed on both measures, as the regulations allowed all importation of Canadian prescription drugs to commercial entities inside the United States so long as the drugs sought to be imported were similar to an FDA-approved drug or its derivative, displayed labeling noting that it was a prescription drug made in and imported from Canada, and underwent marginal testing at the borders of the United States prior to entry. 

On the grounds of whether the importation regulations “pose no additional risk to the public’s health and safety,” the plaintiffs asserted that said regulations posed immense additional risk, as the regulations sought to create an exception to the separate section of the FDCA that mandates that all imported drugs first be checked for adulteration, expiration, or misbranding, even those falling under the new importation regulations. The plaintiffs further pointed to case law that the watchdogs proffered clearly hold that the FDCA provision requiring that no adulterated, expired, or misbranded drug be imported was “mandatory…(with the defendants having) no discretion to make an exception by allowing the importation of drugs that appear to violate this prohibition.”

Moving to the second statutory restriction under the FDCA that required the importation regulations to “result in a significant reduction in the cost…of prescriptions,” the plaintiffs further concluded the defendants’ regulations failed to pass legal muster. The watchdogs pointed to numerous studies on drug costs that showed that the regulations, as is, stood to only reduce the amount the nation spends on prescription drugs by one to two percent, while concurrently standing to “exhaust the Canadian prescription drug supply in less than a year.” 

The plaintiffs concluded the complaint by noting that the alleged illegality and public consequence of the finalized importation regulations may be best understood by pointing out that even the Canadian Government submitted a statement of its opposition to the regulations. The statement said the Canadian drug market was “too small to meet American consumer demand for prescription drugs or have an impact on high drug prices” and warned the defendants that Canada would “employ all necessary measures to safeguards its drug supply and preserve access for Canadians to needed prescription drugs” as the regulations would increase “pressure on the Canadian drug supply, exacerbating drug shortages and limiting access to needed medicines in Canada.” 

The plaintiffs are represented by Covington & Burling