Trade group told compounding pharmacies how to skirt the FDA

By WALT BOGDANICH and SABRINA TAVERNISE

The New York Times

A year before people began dying of meningitis caused by a tainted drug from a compounding pharmacy in Massachusetts, the Food and Drug Administration worried that compounders across the country might be selling another substandard drug, this one possibly made with Chinese ingredients.

But when the FDA began seeking samples to test, the trade group representing compounding pharmacists went on the offensive. Instead of encouraging members to help the agency determine if the injectable drug, used to reduce the risk of premature birth, was substandard, the group tutored pharmacists on how to sidestep requests.

In an email to members, the International Academy of Compounding Pharmacists suggested they respond to any request for samples by saying: "We do not compound or distribute 'samples' of any of our prescription medications to anyone." And if a compounded drug were on the premises, the trade group added, a pharmacist should say it was awaiting pickup by a patient.

A spokesman for the trade group said the instructions were intended to guard against unauthorized release of samples to corporate competitors and not to hinder the FDA investigation. But the memo is emblematic of the industry's frequent and often successful attempts to fend off regulators at a time when concerns are growing about the quality of compounded drugs and the uncertain provenance of their ingredients, some of which originate in China and flow through various repackagers and middlemen with little extra scrutiny, according to interviews with health experts and government records.

Drugs made by compounders — who mix or alter ingredients to create customized medicine for a specific patient — are rarely tested, unless someone is harmed or a complaint is filed. In Texas, a hub of compounding pharmacies and one of only two states that randomly test compounded drugs, random tests by the state's pharmacy board over the last several years found that as many as one in four compounded drugs was either too weak or too strong. The testing results are just slightly better in Missouri, the other state that randomly tests. Potency varied by as much as 300 percent in the Missouri tests.

And records of FDA drug seizures at U.S. borders, as well as several criminal cases, point to a link between drug compounders and Chinese manufacturers, some not registered with the FDA. Records analyzed by The New York Times show that in 62 cases over the last decade, the FDA blocked the importation of drugs for use in compounding; nearly half were from China, one of the largest producers of raw pharmaceutical ingredients, where many manufacturers operate outside the regulatory net.

The FDA said Friday that investigators did not believe the original ingredients used by the MassachusetBalenciaga