FDA Amps Up Foreign Inspections Under Pressure to Bend on Opposition to Drug Importation

Sept. 25, 2019 – The traditional position of FDA’s leadership that the importation of foreign medicines is illegal and may pose safety risks to American patients appears to be in conflict with the Trump administration and other politicians who believe importation to be a key element of lowering prescription drug costs. Now, the agency is increasing foreign inspections, which could be an indicator that the agency is under pressure to bend a bit on this issue.

Municipalities in multiple states report that they have had no issues with drugs obtained through CanaRx, a Canadian company that serves as an intermediary between U.S. patients and Canadian pharmacies. Still, CanaRx received an FDA Warning Letter on Feb. 28 asserting that the FDA’s regulation and oversight of the drug approval process and distribution “protects consumers by requiring rigorous scientific standards, labeling review for accuracy and completeness, and helping to ensure that counterfeit and unsafe drugs do not penetrate the U.S. drug supply, among other things.”

Former FDA Commissioner Scott Gottlieb, M.D. noted at that time that “When companies sidestep important drug safety measures and put patient health at risk by providing unapproved drugs that have been substituted for FDA-approved prescription drugs, it’s the agency’s responsibility to step in to protect the patients.”

Seemingly in line with that approach, the agency recently announced that it had increased overseas inspections by roughly 25 percent between 2014 and 2018, even while reducing U.S. inspections by roughly 12 percent. In addition to its own inspections, under an agreement with the European Union, regulators from 28 other countries are responsible for inspections of some facilities and the FDA relies on those inspections. In China and India, where many generic drugs are manufactured, the agency has worked to increase inspections as well.

“Congress, the Trump administration, some Democratic presidential candidates, and state legislatures are giving increased attention to the importation of drugs as a way to lower health care costs,” noted Coalition for Healthcare Communication Executive Director Jon Bigelow. “One of the key objections has been the difficulty of confirming the quality and safety of imported drugs; in fact, former FDA commissioners Mark McClellan, Andrew von Eschenbach, Margaret Hamburg and Robert Califf signed a joint letter to Congress in March 2017 arguing against drug importation on this basis.”

In that letter, the former commissioners praised the United States’ “closed distribution system” under the FDA and stated that “allowing importation of FDA-inspected facilities and drugs purported to be manufactured domestically for export to other countries and re-imported from those countries to the United Sates cannot meet the requirements under the existing closed drug manufacturing and distribution system because the drugs could not be tracked and certified by the manufacturer.”

The former commissioners also cited the following concerns regarding drug importation:

  • Imported drugs pose serious risks to patients and consumers.
  • Drugs purchased from foreign countries may be substandard, unsafe, adulterated or fake.
  • The FDA lacks the resources needed to oversee a major importation program.
  • The global drug supply system will limit improvements in access.
  • Any improved access and cost savings resulting from importation are likely to be minimal.

The recently reported inspection statistics reflect the FDA’s desire to step up enforcement efforts overseas.

“This new FDA report indicates that the agency is inspecting more foreign manufacturing facilities, prioritizing its efforts on higher-risk facilities, and relying heavily on European Union regulators to inspect even more facilities,’ he continued. “As the former Commissioners pointed out in 2017, however, there are also challenges in monitoring medicines through the entire supply chain and distribution channel, to be sure American patients do not receive unsafe or adulterated agents.”

It is unclear whether the increasing foreign inspections are in any way related to the Trump administration’s July unveiling of two proposals to help pave the way for less expensive drugs here in the United States. These proposals: (1) authorize pilot programs to allow states, wholesalers or pharmacists to import Canadian versions of specific FDA-approved drugs; and (2) give drug companies a negotiating pathway to distribute and sell lower-priced foreign versions of certain drugs.