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The FDA is poised to gain more authority and resources to ensure product quality.
All the headlines about contaminated syringes and tainted peanuts have put pressure on the US Food and Drug Administration to better detect unsafe medical and food products and to take swift action when problems emerge. In February, President Barack Obama criticized the FDA's ineptness in catching contaminated products and urged a "complete review of FDA operations." The Government Accountability Office (GAO) put the FDA on its federal agency "high-risk" list in January because of its failure to protect public health and ensure the safety of drugs, biologics, and medical devices. The complaints are prompting the White House to provide more resources for the FDA while Congress weighs a number of proposals for expanding foreign inspections and giving the agency more enforcement authority.
One positive sign is the boost in the FDA's budget to enhance oversight of food and medical product safety. In the long-delayed 2009 federal appropriations bill, the FDA received more than $2 billion from the government, a $325 million increase over 2008. After adding in user fees, the agency will have a record $2.6 billion budget. That includes $413 million for drugs and $184 million for biologics, plus $500 million in user fees. In return, the legislators expect a significant increase in foreign and domestic facility inspections, expansion of laboratory infrastructure, and upgrades in information technology. The Alliance for a Stronger FDA cheered the funding increase and will press to continue the trend as the Obama administration rolls out details of its 2010 funding plan.
The FDA is slated to receive even more resources to boost inspections under the FDA Globalization Act of 2009 (HR 759), a priority initiative for Rep. John Dingell (D-MI), former chairman of the House Energy & Commerce Committee. Main co-sponsors include Rep. Frank Pallone (D-NJ), head of the E&C Health subcommittee, and E&C Oversight subcommittee chair Rep. Bart Stupak (D-CO), who has been investigating FDA import and inspection failings for several years. Pallone says he plans to hold hearings on the legislation and to move it through the committee simultaneously with health-reform proposals.
The Globalization Act expands the FDA's authority to inspect foreign plants and block questionable imports, and to crack down on those who fail to comply. Regulatory parity is sought to ensure that lax oversight is not luring manufacturers from the US to Asia. All registered manufacturers and importers—including generic drug makers—will have to pay new user fees to support the broader oversight program, and manufacturers will ensure the integrity of product supply chains through electronic pedigrees.
The FDA also would gain the power to recall, destroy, or detain unsafe, adulterated, or misbranded goods. There is added authority to subpoena records and to impose criminal penalties for drug counterfeiting. To improve its inspection program, the FDA is instructed to establish a dedicated cadre of inspectors for foreign food and medical product facilities. And FDA officials are prohibited from closing down field laboratories or district offices without making a case for such changes in a reorganization plan that will be reviewed by GAO and submitted to Congress.
Of particular interest to biopharmaceutical companies is new language in the bill specifying that FDA policies do not override state laws. This provision reflects Democratic opposition to FDA pre-emption of state liability laws, but may be less important in wake of the recent Supreme Court ruling in the landmark Wyeth versus Levine case. Last month, the Justices rejected Wyeth's claim that FDA approval of a drug's labeling overrides state laws and agreed with the plaintiff that FDA decisions are not the last word in drug regulation. The Globalization Act supports this contention and opens the door for state prosecutors and plaintiffs attorneys to bring actions against companies that violate state laws even though they comply with FDA regulations.
The revised Dingell bill addresses some concerns raised by the FDA and manufacturers to an earlier proposal. Instead of requiring country-of-origin information on every ingredient in a product, for example, the FDA gains a year to develop rules for providing this information to the public, possibly through web sites. There's noticeable support for risk-based approaches to ensuring product quality and safety, plus flexibility for the FDA to reduce inspections from every two to every four years at plants that produce low-risk therapies and that present a strong record of compliance with good manufacturing practices (GMPs). All registered pharmaceutical manufacturing facilities will have to develop quality risk-management plans that spell out procedures for auditing and qualifying raw ingredients and for monitoring incoming materials.
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, firstname.lastname@example.org