Lawmakers urge abandonment as CPPI opposes the rule
U.S. Customs and Border Protection announced last week that it would delay implementation of a prescription-drug import rule for 90 days, moving the deadline to Jan. 20. The rule had been set to take effect Thursday. The pause leaves the rule in place but gives people who rely on lower-cost medicines from Canada and other countries time for one more refill, Ken Hunter, executive director of the Campaign for Personal Prescription Importation, said.
The rule, formally titled “Indefinite Suspension of the De Minimis Exemption for Mail Shipments and New Postal Informal Entry,” introduces a stricter process for prescription-drug packages arriving by mail, including new documentation requirements. Under the new procedures, mail from pharmacies outside the United States may be refused if the medications contained are also sold in the United States. Current policy under the 2006 Homeland Security Appropriations Bill prohibits CBP from preventing prescription-drug imports for personal use. The Food and Drug Administration exercises discretion when allowing personal prescriptions to be received from international pharmacies and generally allows them when needed for medical reasons.
Three Florida Republicans — Reps. Aaron Bean, Gus Bilirakis and C. Scott Franklin, R-Fla. — and more than 70 Democrats in Congress signed letters to the Department of Homeland Security, CBP and the Department of Health and Human Services urging the rule be abandoned. The letters warned that tens of millions of people rely on imported drugs.
The Florida lawmakers wrote, “Like over 19 million other Americans, many Floridians have long relied on licensed international mail-order pharmacies as a safe, affordable option for lower-cost prescription medication.” Their letter also said, “We are concerned that Customs and Border Patrol’s new rule, Indefinite Suspension of the De Minimis Exemption for Mail Shipments and New Postal Informal Entry, will inadvertently impact our constituents and millions of other Americans’ access to safe, affordable medications sourced through Canadian and International Pharmacies.”
The Campaign for Personal Prescription Importation has been encouraging lawmakers and others to oppose the new rule through a letter campaign. The nonprofit patient advocacy organization is also advising people to order prescription refills before the rule takes effect. Hunter said more than 110,000 letters have been sent by people who will be affected by the import rule.
Hunter said the 90-day delay offers little comfort for those people. “All we saw in the press release was, it’s still the same rule, we’re just pausing the enforcement of it by 90 days,” he said. “That is just one refill away for people ordering their prescriptions from other countries. Sure, now they can just order one more 90-day supply before getting cut off, which is not really a comfort to anybody out there.”
Hunter said the people contacting him with questions and concerns about the rule are worried about the health consequences of being cut off from prescriptions that may be life-saving. “I get thousands of emails and calls. Some are very panicked, thinking if I don’t get my drug I may collapse or drop dead,” he said. “They’re thinking the worst. That’s why I think CBP, sooner rather than later, should go and make a decision on this to exempt personal pharmaceuticals from this new rule.”
Hunter warned that cutting people off from required medicines could cause a medical crisis. “It’s going to be a medical crisis, essentially, if people are cut off from their required drugs,” he said. “Many of these people that order drugs from other countries, they’ll be seniors, people with high-deductible health plans, people who are uninsured.”
Some of the most common drugs ordered from licensed international pharmacies include Eliquis, used to prevent blood clots, strokes and other heart conditions, and Xifaxan, commonly used to treat irritable bowel syndrome. A three-month supply of Eliquis ordered from a pharmacy in Canada costs about $565, while the same supply and dose costs more than $1,000 in the United States. Hunter said Eliquis is one of the lower-cost drugs commonly ordered internationally. A three-month supply of Xifaxan costs around $2,300 when ordered from Canada, compared with about $12,300 in the United States. Hunter said the most common health conditions for which people order prescriptions internationally include diabetes, heart disease, blood clots and glaucoma.
When access to prescription drugs is in question, people may try to ration their doses, taking half doses or skipping doses entirely to make medications last longer. Doctors advise that skipping doses decreases the effectiveness of most treatments and, in some cases, is dangerous. Hunter argued against rationing doses. “If you talk to any doctor they will say not to do that,” he said. “It is very dangerous to your health. But that’s the state that people are in. They cannot afford their drugs and with these medicines, they’re critically needed. These are things that people need to stay alive but also maintain their health.”
CBP said the rule is intended to strengthen controls on international mail. In a statement, Susan S. Thomas, executive assistant commissioner of CBP’s office of trade, said the agency “is focused on securing our borders and using advance data to identify threats in international mail before they reach American communities.” Thomas added that “the agency is committed to bringing international mail entry procedures into parity with informal entry procedures across all other cargo modes while setting a global standard for modern customs controls in the international mail movement.”