In response to mounting concerns over medication production outsourcing, Senator Sherrod Brown—Democrat-Ohio—has been trying to find out exactly how much production goes on over seas for US pharmaceuticals. It seems as if more and more pharmaceutical companies are outsourcing some of their drug production to countries in which weaker drug safety standards are utilized. In recent months, the issue with drug production outsourcing has come under fire following the Heparin debacle, when it was discovered contaminated Heparin was sourced from a supplier in China.
In an open letter to Janet Woodcock, director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, Brown stated, “In recent testimony to the Senate Committee on Health, Education, Labor, and Pensions, an FDA official acknowledged that American drug companies outsource operations to take advantage of weak drug safety standards abroad.” Brown also asked the FDA for: A probe into pharmaceutical production outsourcing; suggestions on making “drugmakers accountable for products which fail to meet quality standards”; an evaluation on its safeguards for protecting US consumers from “drug products containing tainted, outsourced ingredients”; “volume” details on pharmaceutical ingredients outsourced by US drug manufacturers countries with weaker drug safety regimes; and “the expected incremental annual cost of protecting the public from tainted pharmaceutical ingredients produced in those countries.”
The letter also discussed concerns that Pfizer—the world’s largest drugmaker—currently outsources 17 percent of its active pharmaceutical ingredient (API) production. Brown sent a separate letter to Gerald Migliaccio, a vice present at Pfizer responsible for outsourcing strategy, requesting details on what Pfizer saves annually from outsourcing and the frequency and nature of Pfizer’s outsourcing to countries with less stringent drug oversight standards. “It is no coincidence that drug ingredients produced in countries with weak safety standards are often contaminated,” said Brown. “The FDA must immediately review pharmaceutical outsourcing and make necessary changes to keep American consumers safe.”
The FDA recently joined regulatory bodies in Europe, Canada, and Australia to launch a joint inspections pilot of overseas API manufacturing plants; draft legislation has been proposed—the FDA Globalisation Act of 2008—requiring the FDA to inspect foreign manufacturing plants every four years. Current requirements state each foreign plant must be inspected every two years. At current funding levels, it would take the FDA over 13 years to inspect all foreign plants exporting prescription drugs to the US and 27 years to inspect all foreign plants exporting medical devices.
While drug imports increased in the past five years, inspection funds dropped. Of 3,250 non-US plants subject to FDA inspections last year, only 1,445 foreign inspections occurred—in the last five years, according to a Government Accountability Office study. It’s worse in China where the FDA averaged just 15 inspections in China in each of the last five years, despite that there are 714 plants shipping drug products to the US. If China’s flourishing 17 percent annual growth rate for drug exports continues, they will produce about 25 percent of the world’s pharmaceutical ingredients by 2010, according to the investment firm Credit Suisse.
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