FDA also is making internal changes to better cope with the globalization of the pharmaceutical supply chain and the need
to deal with an ever-growing number of brokers, traders, distributors, repackagers, and manufacturers. A top priority is to
build an interoperable data system for facility registration and product listing. This system would accurately identify who
is manufacturing which medical products and what is being distributed in the US. FDA launched a pilot to encourage manufacturers
to shift from paper registration to electronic filing of establishment-registration and drug-listing information in advance
of required e-filing by June 2009. A July 2008 draft guidance explains which registration and listing information manufacturers
should submit and provides technical information about the e-filing process.
Beyond FDA's borders
FDA also is establishing on-the-ground regulatory offices in critical parts of the world as part of its "Beyond our Borders
Initiative." The first in-country operation will be in China, followed by similar initiatives in India, Europe, Latin America,
and the Middle East (most likely in Amman, Jordan). An additional $20 million from the June 2008 supplemental appropriation
will enable FDA to staff the first four operations by the end of next year with 35 US employees and 13 foreign nationals.
FDA hopes to open offices in Beijing, Shanghai, and Guangzhou, China, by year's end. A relatively small staff of 13 will conduct
site inspections. It also will work with Chinese regulatory authorities to better track local enforcement activities, learn
about legal and political issues affecting drug regulation, and further acquaint Chinese regulators and manufacturers with
US drug-quality standards and enforcement policies.
Establishing official foreign operations involves extensive negotiations. In December 2007, FDA signed a Memorandum of Agreement
(MOA) with Chinese officials to improve the safety of drugs and medical devices. The MOA calls for the registration of Chinese
firms that export to the US, enhanced quality tracking of drugs by Chinese authorities, and notification to FDA of inspectional
failures involving plants that export to the US. The US State Department approved the assignment of FDA staffers to Chinese
offices in March 2008, but a final agreement was delayed by a request from the Chinese for a similar presence in the US, which
the State Department must approve.
India is next in line, and FDA is negotiating to establish offices in New Delhi and Mumbai to oversee the vast volume of drugs
and APIs exported to the US. Offices in Europe will monitor sites producing drugs and medical products for export, while a
Central American operation will focus on the large amounts of fruits and vegetables shipped from that region to the US.
More cooperation
Because US officials cannot inspect every plant or check the high volume of drugs that cross US borders, FDA seeks to collaborate
more with regulatory counterparts to optimize resources and avoid redundant oversight activities (see sidebar, "The plant-inspection
burden"). "Regulatory cooperation no longer is discretionary," said Lumpkin at the DIA meeting. He noted growing interest
in engagement with trusted regulatory agencies to leverage scientific and regulatory resources by the following means:
Sharing foreign-inspection reports.
FDA has more than 70 cooperative arrangements with foreign counterparts, including the Chinese MOA, that permit access to
manufacturing information. Roughly 30 confidentiality arrangements with foreign counterparts, moreover, permit FDA to share
actual inspection reports. Such information can help regulators learn more about foreign facilities in making decisions about
where to target foreign inspection activities.
Joint-inspection pilot.
FDA also is teaming up with the European Medicines Agency (EMEA) and Australia's Therapeutic Goods Administration to better
coordinate foreign drug inspections. The three agencies will consult each other on inspection schedules and reports, initially
for API manufacturers in China and India. The aim is to avoid redundant site visits and to cover more facilities. The three
agencies will review manufacturing sites on each other's lists and agree on which agency should visit them first, Lumpkin
explained. In certain cases, all three regulators may visit a plant together. If successful, the program could expand from
APIs to drug products.
Third-party certification.
FDA wants to accredit government and independent entities that can verify that certain operations or products comply with
US safety and security standards. FDA has launched a third-party inspection pilot for aquacultured shrimp and is working with
foreign authorities on similar programs for medical products. Agency officials would like drug-import legislation to specifically
authorize its use of third-party accreditation, but skeptics on Capitol Hill note that this approach has not worked well for
medical devices.
Information sharing and joint-inspection activities can make the foreign-inspection process more efficient and productive.
But neither FDA, EMEA, nor other regulatory authorities are ceding the right to evaluate and make independent enforcement
decisions regarding any drug product or facility. The hope is, though, that joint inspection activities will breed confidence
in colleagues' approaches and decisions, said Emer Cooke, EMEA's head of inspections, at the DIA meeting. These collaborative
activities could eventually lead to increased reliance on each other's inspections, Cooke suggested, adding that "cooperation,
not competition" is the key to success.
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, jwechsler@advanstar.com
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