US bill seeks more scrutiny of overseas facilities by FDA

A revised bill aiming to boost the US Food and Drug Administration's oversight of foreign manufacturing facilities has been put forward for review by the agency and other interested parties.

The highlights of the Food and Drug Globalization Act (HR 759) include granting the FDA the power to mandate recalls of drug products rather than relying on the current voluntary system and - most controversially - bringing the agency's responsibility for overseeing overseas plants serving the US market into line with domestic facilities.

Representatives John Dingell, Henry Waxman, Frank Pallone and Bart Stupak first tabled HR 759 back in January 2009 but say they have now updated it to "reflect the reasoned priorities and recommendations of the FDA."

Commenting on the release of the discussion draft, Rep. Waxman said it is important not to forget the lessons of the 2008 heparin contamination incident, in which an estimated 200-plus people around the world died as a result of what is considered to be economically-motivated adulteration of active pharmaceutical ingredient (API) sourced from China.

"That catastrophe showed us that we are susceptible to new threats as a result of our increasingly globalised drug supply," he added. "We need to ensure that FDA has modern authorities and enforcement tools to help protect us from these threats."

With the FDA's inspection resources already stretched it is hard to see how it could ramp up its programme to include overseas plants, even with new collaborations with overseas regulatory authorities such as the European Medicines Agency (EMA) and Australia's Therapeutic Goods Administration.

Details of the new version of the bill remain sketchy as it is a work in progress. It does call for increased resources for the FDA as well as a provision for a risk-based inspection programme which could help ease the burden on inspection teams, for example by allowing longer periods between inspections for facilities classified as low risk. However, it also calls for more pre-approval drug inspections of facilities before they can start shipping product to the US market.

Other elements include and a requirement for all facilities manufacturing medicines to develop quality risk-management plans, and requiring pharmaceutical manufacturers to ensure the safety of their supply chain.

Reuters notes that all the sponsors backing HR 759 are Democrats, so it may struggle to progress if Republicans take control of the House of Representatives after the upcoming mid-term elections.

There has been a flurry of bills in both the House and Senate of late seeking to boost the FDA's responsibilities and capacity to oversee the pharmaceutical supply chain.

Last month Senator Michael Bennet tabled the Drug Safety and Accountability Act of 2010 (S. 3690) which aims to strengthen quality standards for pharmaceutical manufacturers and their contractors, improve the oversight of overseas manufacturing sites, and give the FDA authority to order recalls of potentially dangerous drugs.

Meanwhile, another bill (HR 5740) introduced into Congress by Representative Edolphus Towns - who has been leading a Congressional investigation into quality control problems at Johnson & Johnson subsidiary McNeil - is also seeking mandatory recall powers for the FDA.


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