Congress and Obama Seek to Bolster Drug Safety - Pharmaceutical Technology

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Congress and Obama Seek to Bolster Drug Safety
FDA is poised to gain authority and resources to ensure the quality of food and drugs.


Pharmaceutical Technology
Volume 33, Issue 4

Several leading Senators support a food safety bill, which may be more agreeable to food companies. 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 FDA more power to monitor food quality and recall noncompliant products. The Durbin bill reflects concerns of some members of Congress that the massive shift of food and pharmaceutical production to Asia and other regions not only exposes Americans to low-quality and adulterated products, but also may leave the US vulnerable to supply-chain interruptions during a pandemic or other emergency. Sen. Sherrod Brown (D-OH) is examining the shift of drug production overseas and its impact on drug safety, prices, and US jobs. Specialty-chemical manufacturers in the US have complained that lax FDA inspection of foreign drug producers encourages foreign outsourcing and that comparable regulation of domestic and foreign manufacturers is needed to establish a level playing field in the world pharmaceutical market.

Ironically, legislation to increase FDA inspections of foreign drugmakers may reopen the drug importing window. A group of leading Senators has proposed a bill that allows nationwide reimportation 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, the European Union, Australia, New Zealand, and Japan—a policy that anticipates more frequent inspections and a drug-pedigree system.

FDA initiatives

While Congress weighs these options, FDA is issuing guidance and launching programs to bolster oversight of foreign manufacturers and provide pipeline security. FDA, the European Medicines Agency, and Australia's Therapeutic Goods Agency recently launched an 18-month pilot project to collaborate on GMP inspections of API manufacturers. The aim is to reduce the foreign-inspection burden on each agency and to avoid redundant oversight efforts. At the beginning of this year, FDA also joined six federal agencies involved with food, drugs, consumer products, transportation, and trade in issuing a governmentwide policy for ensuring good importer practices. A joint draft guidance recommends ways for importers to prevent or detect hazards or contamination through a product's life cycle.

FDA's "Beyond our Borders" program is expanding into more regions after opening three offices in China a year ago and establishing a formal presence in Brussels. FDA opened an office in Costa Rica, in January 2009, that focuses on food imports. Other outposts are planned for Mexico, South America, and the Middle East. Most recently, FDA launched operations in New Delhi and Mumbai, India, to provide technical advice and inspect facilities, primarily of drug manufacturers that export products to the US.

A new FDA Voluntary Secure Supply Chain pilot program will offer expedited entry to products from drug manufacturers able to demonstrate control over product quality from time of manufacture through entry into the US. The two-year initiative will start with 100 manufacturers seeking expedited treatment for a maximum of five products each. FDA hopes the pilot will demonstrate ways to prevent import of contaminated or counterfeit drugs and will allow the agency to focus its oversight and enforcement efforts on high-risk products and operations.

Another initiative supports supply-chain security by establishing a standardized numerical identifier (SNI) for drug and biologic products, as required by the FDA Amendments Act of 2007 (FDAAA) and reiterated in the proposed Globalization Act. A guidance document issued in January 2009 proposes that manufacturers use a product's national drug code plus a unique eight-digit serial number for identifying drug packages. Manufacturers and repackagers are not required to use SNIs, but those that do should follow the FDA standard. FDA considers this policy key to developing track-and-trace systems and plans further proposals on identifiers for pallets and cases, as well as standards for product authentication and validation.

Another proposal aims to speed up FDA admissibility decisions on drug imports at ports of entry. The agency is querying manufacturers about the feasibility of providing electronic information on product code, country of production, manufacturer, and ultimate consignee to facilitate decisions about which products should be approved and where further review is needed.

Manufacturer responsibility

A common thread in these FDA and Congressional initiatives is that manufacturers ultimately are responsible for the quality and safety of the food and drugs they produce or import into the US. Even with more inspections and tighter border controls, FDA officials acknowledge that it's impossible to detect every product failure or substandard process. Increased foreign sourcing of ingredients creates ever more complex supply chains and added difficulties in protecting against product contamination, diversion, and counterfeiting.

At a conference on pharmaceutical supply chain challenges cosponsored by FDA and the Parenteral Drug Association in September 2008, manufacturers stressed the need for a uniform, universal drug-pedigree system that documents product sourcing. FDAAA gave FDA power that may help it address the legal issues that have stymied regulatory action in this area. Additional legislation may further support policy and program development. Manufacturers want standards that support supply-chain security and global harmonization of policies for ensuring product quality through the supply chain.

For more on this topic, see the online exclusive "Downpayment on Health Reform"

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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