WASHINGTON, D.C. – In what appears to be a major shift in policy, the U.S. Food and Drug Administration has started seizing individuals’ prescription drugs ordered from pharmacies outside the United States.

 The agency has also reportedly raided at least nine Central Florida storefront locations that storeowners say operate simply to help older Floridians order their prescription drugs online at a much cheaper price.

While the importation of prescription drugs is illegal under most circumstances, the federal government announced in 2006 that it would stop seizing small amounts of prescription drugs from pharmacies in Canada.

The policy, which was put in place at the urging of U.S. Sen. Bill Nelson (D-FL) and others, has allowed U.S. residents, mainly seniors, to save on the cost of their prescription drugs by ordering them online from pharmacies in Canada, instead of filling them at pharmacies in the U.S.

And now, following what appears to be a sudden change in that policy, Nelson is demanding answers.

“I appreciate that we need to keep dangerous drugs like fentanyl and counterfeit pharmaceuticals out of our country, but many of my constituents are confused about why they are suddenly receiving a seizure notice instead of their necessary medication – if there has been no change in policy,” Nelson wrote in a letter today to FDA Commissioner Scott Gottlieb. “To the best of my knowledge, no new FDA policies have been publicly announced or shared with Congress.”

Nelson first got involved in the issue in 2004, when he sent a similar letter to the heads of the FDA and U.S. Customs and Border Protection after the government seized an elderly Florida couple’s medication ordered from Canada.

Two years later, at Nelson’s request, the Senate Homeland Security and Governmental Affairs Committee launched an investigation into the custom department’s seizure of prescription drugs purchased for personal use from pharmacies outside the U.S.

Later that same year, Nelson, along with Sen. David Vitter (R-LA), filed legislation, which Congress passed and the president signed into law, that allowed Americans crossing the Canadian border to bring back small amounts of prescription drugs. 

Shortly after Nelson’s bill was approved, Customs announced in Oct. 2006 that it would no longer seize individuals’ prescription drugs purchased from pharmacies outside the United States. That same year, Nelson received assurances from the FDA that it, too, would no longer act on small amounts of prescription drugs being imported into the U.S. for individual use. 

Despite the agency’s 2006 announcement, some Floridians have reportedly received notices in the past couple of months indicating that their prescription drugs are being held at their local post office at the request of the FDA. Around that same time, the FDA reportedly raided at least nine Central Florida storefronts designed to help customers, mainly seniors, buy their prescription drugs online.

“If there has been a change in policy, I urge the FDA to announce those changes publicly,” Nelson wrote. “Americans, especially our seniors, shouldn’t be left in the dark waiting for needed medication to arrive without clear guidance from the agency.”

Following is text of the letter, a PDF copy is available here.

December 20, 2017

Dr. Scott Gottlieb

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Ave

Silver Spring, M.D. 20993-0002

Dear Commissioner Gottlieb,

It has come to my attention that the U.S. Food and Drug Administration (FDA) is seizing prescription drugs purchased by Floridians from Canada and other countries.  I have heard from constituents that the FDA is also raiding Florida storefronts that are reported to help customers order drugs from pharmacies outside the United States.  I have serious concerns about the potential impact that such a shift in policy could have on the ability of Americans who choose to utilize these pharmacies to afford the prescription drugs they need.

The importation of foreign prescription drugs is illegal under most circumstances to control the safety of our supply chain.  However, the FDA has always exercised enforcement discretion in cases of personal use, and I am concerned that the agency may have now changed its policy and has begun taking steps to crack down on seniors who are buying their medications from other countries because they cannot afford to purchase them in the United States.  To the best of my knowledge, no new FDA policies have been publicly announced or shared with Congress.

I appreciate that we need to keep dangerous drugs like fentanyl and counterfeit pharmaceuticals out of our country, but many of my constituents are confused about why they are suddenly receiving a seizure notice instead of their necessary medication – if there has been no change in policy.  I am also troubled by reports that the FDA has raided at least nine storefronts in Central Florida that storeowners say are there to help customers, many of whom are older, navigate the internet to order the drugs they need at lower prices from legitimate pharmacies in Canada and other countries.

These recent actions by the FDA raise serious questions about whether the agency has changed its policy regarding the enforcement of prescription drugs being imported into the country for individual use.  If there has been a change in policy, I urge the FDA to announce those changes publicly – and make known any considerations and conditions that prompted this change in policy.  Americans, especially our seniors, shouldn’t be left in the dark waiting for needed medication to arrive without clear guidance from the agency.

I appreciate your prompt attention to this request.  We must work together to ensure that Americans can access their medications.

Sincerely,