A second concern for IPEC is the Act's provision requiring FDA to inspect every facility, including excipient facilities before
the facility is allowed to offer material to the marketplace. "FDA could never have enough resources to inspect all facilities
which manufacture or distribute excipients. This is where third-party certification comes into play," explains Schoneker.
"We think there should be inspections of excipient companies prior to using excipient suppliers. However, this can't be done
by FDA alone. A combination of FDA inspection (to judge risk) and third-party certification would make sense. It's the only
way to get more audit information in the hands of the users."
There is also speculation that the Obama administration will increase regulations. The new administration may help to "establish
a level playing field for what the expectations are, for what is really required for a pharmaceutical user to use an excipient
or ingredient from a particular supplier," says Schoneker. "It also may bring more standardization and more accountability."
The revised discussion draft of the FDA Globalization Act discusses country-of-origin labeling for APIs and website listing
of all drug components (including excipients). A bill proposed by Senator Sherrod Brown (D-OH) in October would amend the
Federal Food, Drug, and Cosmetic Act to require country-oforigin labeling for active and inactive ingredients, or excipients
(13). IPEC's position is that country-of-origin labeling will not improve safety or consumer choice. "There are many good
manufacturing plants in China and India that we shouldn't be afraid of, and likewise there can be bad suppliers in the US,"
says Schoneker. "The key issue is who you buy from, not where you buy from; country-of-origin labeling will not help with
Import safety and certification.
President George W. Bush established the Interagency Working Group for Import Safety which led to the Action Plan for Import
Safety in November 2007 (14). FDA is part of the working group that finalized the plan, which calls for increased collaboration
and coordination with countries and companies that export products into the US. In addition to signing two memoranda of agreement
with China in late 2007 to protect food and drug imports (15), the US Department of Health and Human Services (HHS) established
two programs in July 2008 tied directly to securing the pharmaceutical supply chain: joint inspections with the European Union
and Australian regulators, and the use of third-party certification (16).
The joint-inspection program began in Fall 2008 as a pilot project and focuses on API manufacturing facilities. The certification
program is also a pilot project, currently focusing on how best to evaluate third-party certification programs for the food
industry. Depending on its success, thirdparty certification may be tested and implemented with drug suppliers as well (16).
Also, the International Conference on Harmonization Guideline Q10 Pharmaceutical Quality System was adopted in June 2008. It specifies that manufacturers include outsourcing activities within their quality systems and
verify the other party's quality systems before engaging in outsourcing (17).
The US Pharmacopeia (USP) already has a certification program for APIs and excipients coming into the US. And along these
lines, FDA is developing a draft guidance on good importer practices (14). In addition, the agency is working on a pharmaceutical
ingredient quality assurance guidance.
Following criticism of FDA's information technology (IT) systems for drug-establishment registration, FDA has made improvements.
(FDA had not inspected the Chinese Changzhou SPL facility, the alleged site of Baxter International's heparin contamination,
due to a database error.) FDA's Kelly says in addition to efforts to better identify drug firms, including firms named in
applications, progress includes:
- Establishing a pilot program, to be fully implemented this year, for electronically registering and listing drugs.
- Selecting 10 contractors to receive up to a total of $2.5 billion for IT and services for the management of data centers over
a decade. This funding will allow FDA to acquire, analyze, and act on data that are critical for import protection.
- Work toward the use of a universal identifier such as the Dun and Bradstreet number (or DUNS) that would allow the agency
to use robust, established databases to verify the accuracy of registration information.