Voices against US drug importation gain ex-FDA heads

There are a number of ideas being put on the cards for the US to help lower its eye-watering drug bill, but importing cheaper therapies from abroad – an idea put forward by some top politicians – is not one that is being backed by the industry, or its former gate keepers.

Earlier this month, the US pharmaceutical lobby group PhRMA, as well as The Partnership for Safe Medicines (PSM), came out against legislative plans to import high-cost prescription meds from across the border in Canada to cut down on medicines bills, saying it would risk boosting fakes in the country.

The plans, first unveiled by former Democrat presidential hopeful Sen. Bernie Sanders, have now also found a critical voice in the form of four former commissioners of the FDA, the agency which regulates medicines in the US, who write in an open letter to Congress that the plans: "Represents a complex and risky approach—one that the evidence shows will not achieve the aim, and that is likely to harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation's medical products."

The letter was signed by Robert Califf, the most recent FDA commissioner, as well as Margaret Hamburg, Mark McClellan, and Andrew Von Eschenbach.

Their main concern is the risk posed to American consumers, echoing the worries of PhRMA and PSM, saying that: "Drugs purchased from foreign countries may be substandard, unsafe, adulterated, or fake."

They add that since 1999, the FDA has conducted investigations to curb online sales and distribution of these types of products. "Given the enormous volume and complexity of imports to the US, obtaining sufficient resources and expertise to screen and verify the authenticity of every product destined for American consumers presents enormous challenges.

"Even if spot-checking discovered a dangerous or counterfeit product, in the absence of the closed system currently in use, there would be no way to trace that product to its origin or intervene to protect other consumers before irreparable harm occurs."

The letter also says that the FDA, which could see less money from the government coming its way in the coming years and a slashing of its regulations, also: "lacks resources needed to oversee a major importation program," should this legislation be passed.

Califf, in an interview with the Washington Post, said that the vast majority of Internet sites that advertise as being Canadian "are actually based in South America, Eastern Europe and Russia," and therefore, no one really knows what they are getting when ordering online.

"What if you think you are taking a [cholesterol-lowering] statin, but you aren't?" he said to the newspaper. "You wouldn't feel any different. ... And what if you were 70, with six medical problems being treated with 10 drugs, and you got sick and died. Who would know?"

The former FDA heads conclude by asking Congress to think of other ways of addressing problems with current drug pricing, "and take steps to bring down drug costs and health care costs more generally," rather than what they consider to be a drastic and unsafe importation approach.