Legislation proposed for FDA foreign inspections

By Nick Taylor

- Last updated on GMT

Related tags: Pharmaceutical drug

Draft legislation has been put forward which would require the US
Food and Drug Administration (FDA) to inspect foreign manufacturing
plants every four years.

The Food and Drug Administration Globalisation Act of 2008 is based around four existing bills and has come to prominence as a result of the turbulent times recently faced by the FDA, including the heparin contamination case, which has been linked to 62 deaths, as well as concerns over the safety of imported ingredients such as glycerin. Until an inspection is carried out any drug, active pharmaceutical ingredient, class II or III device or device component may not be sold interstate. This covers anything manufactured, prepared, propagated, compounded or processed at the site. To enforce the monitoring of foreign plants the bill proposes the creation of a permanent foreign inspection force, with staff assigned to specific countries. This way they would gain an understanding of the companies, language and culture, leaving them better prepared to perform their duties. Some of the funding required to support the initiative will come from an annual registration fee to be paid by drug and device manufacturers, the amount of which will be determined by the Secretary. The implementation of this is proposed to take place at the start of the 2009 fiscal year. In addition drug labels and medical devices would have to state the source of the active ingredient or the nation in which the device was manufactured. Those behind the legislation feel that consumers have the right to know where their purchases come from. Speaking about the legislation Senator Dingell said: "For example, if it comes from Great Britain, you're going to assume it's pretty safe. If it comes from Canada, it's probably pretty safe. If it comes from China, you're going to say, 'Holy cats, we better watch out​.'" The Pharmaceutical Research and Manufacturers of America (PhRMA) has not taken a stance on the inspections or labeling but has weighed into the debate over the FDA's funding. Ken Johnson, senior vice president PhRMA said: "The agency's responsibilities have soared, yet its resources have not kept up to meet these increasing demands​." The senate had sought a 20 per cent increase to the FDA's funding but President Bush's budget only granted a 3 per cent rise to the agency. There are aspects of the draft legislation that the Bush administration had wanted to be brought into statute, including a reduction in the FDA's powers to recall products. Under this legislation the FDA would merely be able to request companies undertake a recall, whereas it can currently force a recall. The first hearing of the draft is due to take place on April 24, with others expected to follow.

Related topics: Processing, Globalisation, QA/QC

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