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

FDA also would gain the power to recall, destroy, or detain unsafe, adulterated, or misbranded goods. The bill includes added authority to subpoena records and to impose criminal penalties for drug counterfeiting, a power long advocated by pharmaceutical and legal authorities. To support a larger inspection program, FDA is instructed to establish a dedicated cadre of inspectors for foreign food and medical product facilities. FDA officials, moreover, are prohibited from closing down field laboratories or district offices without making a case for such changes in a reorganization plan that would be reviewed by GAO and submitted to Congress.

Of particular interest to pharmaceutical companies is new language specifying that even rigorous FDA policies and programs do not override state laws. This provision reflects Democratic opposition to FDA preemption of state liability laws that are more stringent than federal standards. The measure may be less important, however, in the wake of the recent Supreme Court ruling in the widely watched Wyeth v. Levine case. Last month, the Justices rejected Wyeth's (Madison, NJ) claim that FDA approval of a drug and its labeling overrides state laws and agreed with the plaintiff that FDA decisions are not the last word in drug regulation. The provision in the Globalization Act supports this principle and clearly opens the door for state prosecutors and plaintiffs' attorneys to bring actions against companies that run afoul of state rules, even if they comply with FDA regulations.

The revised Globalization Act does address several concerns that FDA and manufacturers raised about an earlier proposal. Instead of requiring country-of-origin labeling for every ingredient in a product, FDA would gain a year to develop rules for providing this information to the public. That review process may permit alternative methods for providing useful patient information about the sources of drug components, possibly through websites or other sources.

The legislation further encourages FDA and industry to adopt risk-based approaches for ensuring the quality and safety of imported pharmaceuticals and active ingredients. FDA would gain flexibility to schedule inspections based on the risk of a specific product and compliance history of the company, which could reduce inspections from every two to four years at firms that present a strong record of compliance with good manufacturing practices (GMPs).

Pipeline protection

An important section of the Dingell bill addresses ways to secure drug-manufacturing pipelines, an FDA initiative that has been mired in controversy for some 20 years. The agency has been working with industry since 1988 to develop policies and standards for ePedigrees on ingredient sources and all parties involved in drug manufacturing, distribution, packaging, and dispensing. Objections from small wholesalers, repackagers, and pharmacists, however, have blocked agreement, ultimately through a lawsuit challenging FDA's ePedigree rules.

The situation has become even more confusing and costly as states have enacted diverse pedigree reporting and tracking policies, and major retailers have established electronic identifier requirements for pharmaceutical products. Industry has supported numerous track-and-trace pilots and now is pressing for uniform rules for ensuring the integrity of drug supply chains throughout the world.

The Globalization Act would tackle this thorny issue by requiring manufacturers to maintain records about all processors, distributors, and shippers that handle a drug product through its preparation, compounding, processing, distribution, shipping, importing, and warehousing. This information would be available electronically. Repackagers would be exempt from the pedigree program, however, and it will be a challenge to decide which party is responsible for which information.

Legislative alternatives

All the headlines about food and drug safety failures are generating additional legislative proposals in the House and Senate. Rep. Rosa DeLauro (D-CT), chairman of the House Appropriations Committee that oversees FDA's budget, recently reintroduced a bill to separate food regulation from medical-product approvals by creating a separate Food Safety Administration. DeLauro believes that such a transformation of the regulatory system is needed to give food safety the attention it requires.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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