US Senator seeks probe into outsourcing

A US senator has asked the Food and Drug Administration (FDA) for a probe into outsourcing of production for pharmaceuticals, as well as ways to make drugmakers accountable for products which fail to meet quality standards. 

Sen Sherrod Brown (Democrat, Ohio) especially asked about the activities of the leading global drug major, Pfizer, and standards in China and India. In April this year, Gerald Migliaccio, the firm's vice president of Quality, EHS and Agility, had stated that 17 per cent of Pfizer's active ingredients and drug manufacturing is outsourced.

Sen Brown, announcing that he has asked the FDA and Pfizer to respond to his queries about safety standards in other countries, said: "it is no coincidence that drug ingredients in countries with weak safety standards are often contaminated." The Ohio Senator added: "the FDA must immediately review pharmaceutical outsourcing and make necessary changes to keep American consumers safe."

Brown's open letter to Janet Woodcock - director of the FDA's Center for Drug Evaluation and Research (CDER) - asks the agency to evaluate its safeguards for protecting US consumers from "drug products containing tainted, outsourced ingredients."

The letter also expresses concern that the world's largest drugmaker Pfizer outsources 17 per cent of its active pharmaceutical ingredient (API) production.

The initiative follows from concerns raised by the recent problems with contaminated heparin.

Several countries around the world have recalled heparin products after discovering they contained contaminated heparin sourced from a supplier in China. It has been suggested that the FDA's inspectors had visited the wrong production site in China.

For its part, the FDA is already taking measures to remedy this issue, and recently joined with regulatory bodies in Europe, Canada and Australia to launch a pilot project for joint inspections of overseas API manufacturing plants.

Draft legislation has also been proposed - the FDA Globalisation Act of 2008 - which would require the FDA to inspect foreign manufacturing plants every four years, and the agency has said it will issue new guidance to help importers guard against substandard and countefeit imports of both ingredients and finished medicines.

Meanwhile some observers believe that it makes no sense to expect the FDA to serve as the world's regulatory watchdog.

Writing in the New England Journal of Medicine earlier this month, Jerry Avorn, a professor of medicine at Harvard Medical School, notes: "It would be wrong to view the heparin debacle as primarily an FDA failure," adding that the agency's budget for surveillance of foreign drug manufacturers "is an order of magnitude or two too small."

At current funding levels, it would take the FDA more than 13 years to inspect all foreign plants exporting prescription drugs to the US and 27 years to inspect all foreign plants exporting medical devices, he points out.

"Criticising the FDA for failing to stay on top of such inspections when it doesn't have the requisite funds is victim blaming, not policy analysis," comments Avorn.