MORE PROPOSALS
The focus on unsafe medical and food products is generating additional legislative proposals in the House and Senate. Rep.
Rosa DeLauro (D-CN), chairman of the House Appropriations Committee that oversees the FDA's budget, recently re-introduced
a bill to separate food regulation from medical product approvals by creating a separate Food Safety Administration that will
provide needed attention to food safety. The FDA Food Safety Modernization Act, sponsored by Senate majority whip Richard
Durbin (D-IL), proposes more targeted user fees for domestic and foreign food operators to support increased inspections,
while also giving the FDA more power to monitor food quality and to recall noncompliant products.
The Durbin bill also addresses the need to protect food products from intentional contamination, an issue that reflects concerns
about increased overseas production of pharmaceuticals and vaccines. Some members of Congress complain that the massive shift
of pharmaceutical production to Asia and other regions not only exposes Americans to low quality and adulterated products,
but may leave the US vulnerable to supply chain interruptions during a pandemic outbreak or other emergency.
Ironically, legislation that increases FDA inspections of foreign drug makers may re-open the door to drug importing. A group
of leading senators is sponsoring a bill to allow nationwide re-importation of prescription drugs, claiming the program would
save $50 billion over 10 years. All the imports would have to come from FDA-approved manufacturing plants in Canada, Europe,
Australia, New Zealand, and Japan—a policy that assumes more frequent inspections and a viable pedigree system.
While Congress weighs these proposals, FDA is issuing guidance and launching initiatives that increase overseas inspections
and provide greater assurance of drug quality. The FDA's "Beyond Our Borders" program is expanding into South America and
India after opening offices in China a year ago and establishing a more formal presence in Brussels, Belgium. At the beginning
of this year, the FDA also joined six federal agencies in issuing a government-wide policy to ensure "Good Importer Practices"
for preventing and detecting hazards or contamination through a product's lifecycle. A new FDA voluntary secure supply chain
pilot program will offer expedited entry to drug manufacturers able to demonstrate control over their supply chain from time
of manufacture through entry into the US. The two-year initiative will start with up to five products from 100 manufacturers
and aims to identify strategies for preventing import of contaminated or counterfeit drugs. And the FDA is supporting supply
chain security by establishing a standardized numerical identifier for drugs and biologics, as required by the FDA Amendments
Act of 2007. A guidance document issued in January (2009) advises manufacturers to use a product's national drug code plus
a unique eight-digit serial number for identifying drug packages.
A common thread in FDA and Congressional initiatives is that manufacturers are ultimately responsible for the quality and
safety of their products, and that the FDA will never be able to detect every product failure. Increased foreign sourcing
of ingredients creates ever more complex supply chains and new challenges in protecting against product contamination, diversion,
and counterfeiting. Manufacturers emphasize the need for a universal drug pedigree system that can document product sourcing,
and additional legislation may further support harmonization of practices and policies for ensuring product quality through
the supply chain.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, jwechsler@advanstar.com
|
