Drug Imports under Scrutiny - Pharmaceutical Technology

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Drug Imports under Scrutiny
FDA is taking several measures to ensure that imported drugs meet manufacturing standards.

Pharmaceutical Technology
Volume 9, Issue 32, pp. 3444

Authority and responsibility

FDA oversight of foreign facilities and food and drug imports is a hot topic on Capitol Hill. The E&C has been investigating the heparin incident and FDA's foreign-inspection failures. Now the committee seeks to discover whether FDA took appropriate action to keep adulterated Ranbaxy products out of the US. Observers hear murmurs about the beginning of another generic-drug scandal—20 years after fraudulent activity rocked FDA and the then-nascent generic-drug industry.

E&C Chairman John Dingell (D-MI) and Senator Edward Kennedy (D-MA), chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, have been developing legislation, referred to as the FDA Globalization Act, to enhance FDA's authority and to increase funds for its inspections and compliance programs. Government officials agree on the need for authority to investigate overseas violations of the Food, Drug, and Cosmetic Act and to challenge criminal conduct occurring outside the US that threatens the health and safety of US consumers. The agency also wants to be able to destroy unsafe products at the border, to impose stiffer penalties for criminal offenses involving fraudulent or counterfeit products, and to block imported products when agency officials encounter "undue delay, limits, or denials of access to foreign manufacturing sites," Woodcock testified in May.

Global enterprise
But she voiced concern about imposing broad new user fees on importers and manufacturers, except those fees levied on entities that receive special benefits from government programs. Instead, FDA and other regulatory authorities emphasize that manufacturers must do more to ensure the safety and quality of imported APIs and products. If pharmaceutical companies in the US and Europe want to outsource manufacturing, they can expect closer scrutiny of how well they check suppliers' operations and component specifications, especially for products from abroad.

Sen. Sherrod Brown (D-OH), for example, is investigating whether foreign drug outsourcing aims to obtain cheaper and less stringently regulated imports at the expense of lost jobs and health threats for Americans. Brown asked Woodcock to explain comments at an April 2008 Senate HELP Committee hearing that drug companies outsource to obtain products from parts of the world with "lower, less stringent standards" and reduced labor costs. Brown also has queried Pfizer (New York) and Merck (Whitehouse Station, NJ) officials about whether plans to increase outsourcing raise risks. The senator wants to know which countries Merck plans to outsource to, local wages in those regions, and how Merck will track the chain of custody for each ingredient and ensure that all facilities meet quality and safety standards. If pharmaceutical companies outsource to save money, Brown says, those reduced costs should translate into savings for US consumers.

More inspections

To prevent future heparin crises, FDA is expanding on-site visits to foreign facilities that produce drugs and APIs for the US market. Discussing the heparin incident, von Eschenbach explained that a timely FDA inspection of the Chinese API producer probably would not have detected the dangerous contaminant or blocked similar activity by other suppliers. But an FDA inspection might have exposed flaws in the production system that could have shut down that plant.

FDA conducted 322 foreign inspections in fiscal year (FY) 2007—a big jump up from 212 in FY 2006, 266 in FY 2005, and 260 in FY 2004. The plan is to carry out 500 foreign inspections in 2009, which will be supported in part by $150 million in supplemental appropriations for FDA approved by Congress in June 2008. Most of these visits involve preapproval inspections (PAIs), which are required for every plant listed on a new drug application or supplement before the product can be distributed in the US.

In addition to more PAIs, FDA plans to boost routine surveillance of overseas manufacturers. Similar to its risk-based approach for targeting US GMP inspections, the agency will identify foreign plants that warrant inspection based on dosage form, date of last inspection, shipping volume, and the firm's compliance history with both FDA and local regulatory authorities.

The plant-inspection burden
FDA's Office of Regulatory Affairs, which operates the agency's field inspection force in the US and abroad, is establishing an international cadre of inspectors to conduct site visits around the world. And whenever FDA obtains information that raises doubts about the safety of a regulated product, it will rapidly conduct a "for cause" inspection, whether foreign or domestic.


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