Last April, US Representatives John Dingell (D-MI), Frank Pallone, Jr. (D-NJ), and Bart Stupak (D-MI) issued a discussion
draft of the Food and Drug Administration Globalization Act of 2008 to improve the FDA inspection process (10). Revised in
July, the discussion draft proposes that:
- All drug facilities operating within the US or exporting products to the US register with FDA annually (a registration fee
would generate resources for inspections)
- FDA inspect foreign and domestic facilities every two to four years, provided sufficient information has been given to the
agency to assess risk (a manufacturer would not be able introduce a drug or ingredient into the marketplace until an initial
facility inspection has been conducted)
- Restrictions be placed on the entry of imports that lack safety documentation
- Drug establishments implement a quality riskmanagement plan
- Manufacturers test and verify drug identity and purity
- FDA issue fines for violations of drug-safety requirements; the agency's authority would be extended to recall and detain
dangerous drugs as well as to destroy counterfeit or adulterated imports
- Electronic pedigrees document a drug's supply chain
- Country-of-origin labeling identify the source of APIs and their place of manufacture (11).
Although the Globalization Act is still circulating as a proposal within Congress, FDA Press Officer Christopher C. Kelly
says the agency is already tweaking its inspection process to be more global in nature. "We are putting an emphasis on the
supply chain during the regular course of our good manufacturing practice inspections and preapproval inspections," he says.
"We are looking at sourcing and actively participating in industry conferences and professional forums on the topic as well
as attempting to increase our coverage." FDA is opening up several offices abroad and dedicating more inspectors for foreign
The agency is also improving its system for registration of foreign facilities. The FDA Foreign Facility Registration Verification
Project is meant to establish a contract relationship with nongovernmental organizations that have an office overseas that
can verify, as trusted FDA agents, the registration data of foreign firms that are shipping to the US. "The process will include
visiting the foreign firms, verifying, and documenting the existence of the firms, and confirming the firms manufacture the
products that FDA import records indicate the firms export to the US," explains Kelly. The project is expected to include,
but not be limited to China, India, and Mexico.
Dingell plans to introduce a bill ref lecting the revised discussion draft in the House Energy and Commerce Committee early
this year (12). Some industry groups are voicing concerns on certain aspects of the proposed legislation.
The International Pharmaceutical Excipients Council (IPEC), for example, plans to submit written comments to the committee
about the Act's proposals. Although IPEC is supportive of the fact that the Act, if passed, would put more pressure on what
a user needs to do to qualify its suppliers, the organization is concerned about the bill's call for a nofee registration
of excipient plants.
"There should be a fee for them just like there is for API facilities," says David R. Schoneker, who ended his term as chairman
of IPEC–Americas on Jan. 1. Schoneker is also a member of Pharmaceutical Technology's editorial advisory board. "If you have a registration process that only involves an Internet form and a registration number,
well, the bad guys can do that too. Some may try to tout the fact that they have an FDA registration number as if they've
been FDA-approved. A reasonable fee is necessary, and pharmaceutical companies should only be allowed to use excipients from
registered excipient suppliers."