The FDA has proposed amendments to the Food and Drug Administration Safety and Innovation Act (FDASIA) to enforce the 2012 Federal Food, Drug and Cosmetic Act (FD&C Act), which allows destruction of prescription drugs worth less than $2,500 (€1,800) that have been refused entry into the country, usually on safety grounds.
While the Agency said the proposed regulation will allow it “to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain,” consumers and business groups have been divided. PhRMA (Pharmaceutical Researchers and Manufacturers of America) has supported FDASIA’s implementation , calling counterfeit and misbranded drugs “one of the most significant and growing threats to the legitimate supply chain.”
By contrast, almost 9,000 people have signed a Change.org petition calling on the US Secretary of Health to allow personal importation, saying high drug costs prevent millions of Americans from filling their prescriptions, and that five million US citizens buy their medicines abroad.
“I am signing this petition because my husband and I both would not be able to afford important medications if we were forced to buy them in the US,” said one respondent.
‘Identical’ tablets blocked
Gabriel Levitt, VP of online drug stockist rating site PharmacyChecker, told in-Pharmatechnologist.com that while his company supports FDA efforts to protect Americans from unsafe drugs, “we really feel there’s the potential that either they’re going to overreach, or they’re purposefully changing course with how they’ve treated personal drug importation in the last 15 years.
“I have to believe them that part of their motivation is protecting the public health, and I have to hope they’re not trying to protect the interests of the pharmaceutical industry who are interested in protecting their higher prices.”
Levitt said grounds for confiscation can go beyond safety and encompass drug branding, including packaging or the colour of a pill.
“For example, a drug that’s manufactured by Pfizer or Eli Lilly or Merck – let’s say it’s made in Ireland at one of Pfizer’s factories – they manufacture the pills and then they package them differently for UK licensed pharmacies from US pharmacies, because the UK has different regulations for packaging. So if an American buys a drug from that pharmacy, the FDA can call it misbranded. But it could literally be the exact same drug.”
Levitt said the same problem can occur when countries have varying rules about warning labels. While these are important, “they’re often very similar” between regions, he said. He added that the FDA can also reject re-importation of drugs bought abroad which were originally manufactured in the US.
Importation: personal vs commercial
Levitt suggested the FDA should consider “the public health perspective” and treat commercial and personal importation of drugs differently, noting the latter can delay a patient’s treatment, unlike the confiscation of freight shipments.
“To the credit of Congress who drafted the bill, they did require that importers be notified about the refusal of their drug of their drug import. What we want to make sure is that this process actually works for real consumers, that they don’t just mimic the process for commercial importation.
Notifying importers is already required by law, and Levitt said his company “wants to be sure that requirement is faithfully carried out in a way that gives the consumer the opportunity to have the drug released if they can show it meets certain safety criteria.”
US Congress introduced the Personal Drug Importation Fairness Act of 2013 last December to allow importation from Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the EU, or the EEA of prescription drugs with matching ingredients and strength as an FDA-approved medicine. The bill is currently being considered by the Subcommittee on Health.