Senators seek greater enforcement powers for FDA

A bill introduced in the USA would give the Food and Drug Administration (FDA) greater powers to inspect and seize medical products made both domestically and overseas.

The Drug and Device Accountability Act of 2009 has been tabled by Senators Chuck Grassley (R-Iowa; pictured top) and Ted Kennedy (D-Massachusetts), and is aimed squarely at tackling the issues raised by the “increasing amount of drugs and active pharmaceutical ingredients Americans use are being manufactured in foreign countries.”

The bill would give the FDA the power to detain medicines - including ingredients - and medical devices when inspectors believe they may be “adulterated or misbranded.” It would also set down clear responsibility - with civil and criminal penalties for false or misleading information – for individuals who submit “a drug or device application or a report related to safety or efficacy.”

At the moment the agency has to rely on other agencies, such as US Customs, to seize suspect products. It would also grant the FDA the power to subpoena individuals and require them to testify in court or face punishment. To fund the new measures, the bill would levy fees on plant inspections.

The bill also helps define a misbranded medicine, indicating, for example, that is could include products which fail to meet conditions related to the registration of establishments, identification of prior transactions, labelling indicating the country of manufacture, and provision of required information on importation.

It says a drug can be considered adulterated if it does not meet certain conditions related to verification of identity and purity, identification of establishments, consistency with current manufacturing technologies, and conformity with good distribution and import practice.

In his speech to the Senate, Grassley cited last year’s contaminated heparin scandal as highlighting “significant weaknesses in FDA’s oversight of production and supply chain.”

He said the tabled legislation is “a practical solution to beefing up the FDA's inspection work, both domestically and abroad,”  pointing to the 2008 Government Accountability Office report that found foreign drug manufacturing facilities were inspected at one-fifth the rate of domestic plants.

Since that report was published the FDA has opened offices in China and India, revamped its Good Importer Practices guidance, and drafted guidance which recommends the standards that industry should use for the identification of individual packages containing prescription drugs to facilitate track and trace systems.

The new bill goes further and would establish and a team of inspectors dedicated to inspections of foreign establishments and foreign facilities.

In January, the FDA also launched a voluntary pilot programme – known as Secure Supply Chain – aimed at preventing the importation of drugs that do not comply with FDA requirements. The hope is that such a scheme would allow the agency to focus its resources on foreign-produced drugs that fall outside the programme.