I like it when the government takes its responsibility to
protect us seriously. Last week, Senator Sherrod Brown (D-OH) started asking FDA to evaluate how pharmaceutical outsourcing affects public safety. Brown no doubt had the contaminated heparin story in mind when he asked CDER Director Janet Woodcock about the connection between outsourcing, contaminated ingredients, and countries with weak safety regimes.
According to Woodcock, analysts observe that pharmaceutical companies buy outsourced ingredients to take advantage of “lower, less stringent standards in some parts of the world.” But doesn’t FDA exist to ensure that there is no such advantage to be taken? Even if other countries have lower safety standards, FDA is supposed to be a firewall to protect patients from unsafe products.
In a letter to Woodcock, Brown took the next logical step: he asked her to estimate the volume of ingredients sourced from countries with weak safety standards, to estimate the cost of protecting the public from potentially contaminated ingredients, and to name the tools FDA needs to hold drugmakers accountable.
Brown also put industry, in the person of Gerald Migliaccio, Pfizer’s vice-president of quality, in the hot seat. Migliaccio said cost savings was a major reason that pharmaceutical companies outsource ingredients and processes. In a letter to Migliaccio, Brown asked how much Pfizer saved each year by outsourcing.
In theory, Pfizer would pass its savings along to consumers, but Brown dryly noted, “There is no evidence that outsourcing is translating into any savings for patients in the US.” On the contrary, Americans pay higher prices than anyone else for prescription drugs, Brown said. On top of that, America must spend extra money to mitigate the risk posed by ingredients produced in countries with weak safety regimes.
Brown’s questions raise the point that outsourcing should benefit patients as well as industry. It’s fine for industry to profit from outsourcing if it brings efficiency and savings. But advantages for industry should not come at patients’ expense. Brown’s investigations won’t necessarily have major results, but I’m glad to see a legislator taking his responsibilities seriously and using his power to exercise oversight for the public good.