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Issues
Foreign Inspections and Reimportation
GPhA Position
GPhA has long supported measures to strengthen the foreign drug inspection system to assure safety across the board for all pharmaceutical products and to ensure substantial compliance with Good Manufacturing Practices (GMPs). We have encouraged Congress to adopt the following principles to enhance its foreign inspection program:
- Strengthening FDA Funding. It is critical that the current appropriations funding for domestic inspections be maintained. GPhA also supports annual registration or inspectional fees to fund inspections of foreign facilities. However, these fees should not supplant current funding to ensure the safety and integrity of the domestic inspection program.
- Establishing one uniform, high-quality inspection system for both domestic and foreign facilities. We must ensure that all countries adhere to our country's gold standard for drug safety. By establishing one uniform, high-quality inspection system for both domestic and foreign facilities, consumers would be assured that products are made in facilities that work to protect safety. Such a system would also guarantee that inspections are conducted with the same frequency and same extent, whether the facility is domestic or based overseas.
- Implementing a "risk-based" approach. To help maximize resources and ensure that facilities at greatest risk receive the greatest attention, the generic industry supports a "risk-based" model for the foreign inspection program. This model would prioritize inspection resources according to a company's safety and compliance track record.
Key Points
The U.S. has the world's gold standard for ensuring the safety of our drug supply and protecting the public health must always be our number one priority.
The generic industry goes the extra mile in ensuring safety by investing tens of millions of dollars annually into making sure that manufacturing plants are producing safe and effective medicines.
Strengthening our foreign inspection system will also deal with the important issue of counterfeited drugs. The good news is that less than one percent of all U.S. drugs are counterfeited, with IMS Health data actually showing a decline in the number of incidents of counterfeiting.
And because generics cost considerably less than brand drugs, counterfeiting is not a big problem in the generic industry. However, any problem is something we must all act to address.
Background
FDA-approved prescription drug manufacturers – brand and generic -operate in a highly regulated environment to ensure the safety and efficacy of medicines taken by millions of Americans every day. Congress and the FDA have promulgated strict rules governing the development, manufacture, approval, packaging, marketing and post-marketing surveillance of FDA-approved prescription drugs. FDA has in place robust quality product-specific standards that must be adhered to from lot-to-lot as well as rigorous good manufacturing standards for facilities that manufacture and supply prescription drugs and the active ingredients thereof. Both brand and generic prescription drug manufacturers adhere to the gold standard of review and regulation – a standard that works to ensure safety and efficacy.
It is critical that the domestic, closed pharmaceutical distribution system be strengthened to address existing weaknesses in the oversight of the unapproved and unregulated drug market to protect consumers from substandard and potentially harmful medicines, and to prevent counterfeit products from entering the US drug supply. There should be ONE, HIGH QUALITY STANDARD implemented and enforced.
Our Foreign Inspection System is only as strong as its weakest link. Failure to infuse adequate resources and implement reform measures will perpetuate a system where there is one standard for domestic FDA-approved prescription drug manufacturers and a lesser standard for foreign drug manufacturers.
Related Information
Studies
December 21, 2004 - Commerce Dept. Study, Pharmaceutical Price Controls in OECD Countries (1.57MB PDF)
Testimony & Content
July 14, 2004 - Examining the Implications of Drug Reimportation
July 1, 2004 - Comments on the International Drug Pricing Study (441.37KB PDF)
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