Limited Resources, Expanding Imports Challenge Regulators - Pharmaceutical Technology

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Limited Resources, Expanding Imports Challenge Regulators
The rise in overseas manufacturing undermines FDA oversight of drug quality.


Pharmaceutical Technology


Inspections and imports

Congress is likely to enact such food and drug import legislation this year because FDA's Office of Regulatory Affairs (ORA) has suffered from the budget crunch even more than most FDA operations. ORA is unable to cope with the soaring volume of imported food and regulated medical products. Agency officials proposed a major field consolidation plan two years ago to confront staff reductions that would have closed all five of ORA's regional offices, reduced the number of district offices from 20 to 16, and shut 7 of 13 field laboratories (see "FDA Seeks Streamlined, More Effective GMP Inspections," Pharmaceutical Technology, May 2007). But Congressional leaders blocked the closures, and ORA Director Margaret Glavin promised last summer to take a "fresh look" at how ORA could meet its many challenges. Even so, Congressional leaders reiterated in the 2008 appropriations bill that FDA should not close or consolidate any of its field offices or laboratories pending a re-examination of how the agency will address rising concerns about unsafe food and drug products from abroad.

In recent months, FDA has had to tackle melamine-contaminated pet food and tainted toothpaste from China that moved into the US through the nation's hole-ridden import-control system. Although Americans escaped medicines laced with diethylene glycol (DEG) that took lives in developing countries, the risk that DEG might appear in imported products prompted the agency to recommend that manufacturers test to ensure that glycerin used to prepare liquid drugs is not contaminated (see "Ensuring Quality for Dietary Supplements," Pharmaceutical Technology, August 2007). Chinese regulatory authorities promised improvements and even executed the head of the State Food and Drug Administration for corruption.

The Bush administration established an import-safety task force headed by Health and Human Services Secretary Mike Leavitt to map out improvements to the US food and drug import system. And Congress ramped up investigations and held hearings about how to improve systems for detecting and halting the importation of unsafe foreign food and drug products. Several legislative proposals emerged, including one from House Energy and Commerce Committee Chairman John Dingell (D-MI) that would impose user fees on imported food and drug shipments to bolster US border controls and foreign inspections. The Senate Finance Committee has indicated interest in tackling import safety this year, and Sen. Kennedy is working on a comprehensive food safety bill that would address these issues. Most legislative initiatives would enhance FDA's authority to mandate product recalls, halt imports from noncompliant producers, boost penalties for illegal activities, and require foreign manufacturers and importers to certify compliance with quality standards.

At a November Energy and Commerce hearing, Dingell and his colleagues examined FDA's foreign drug inspection program more closely. Subcommittee Chair Bart Stupak (D-NJ) described the program as being "simply in shambles." Ben England, attorney and former FDA enforcement official, pointed out that FDA's inspection and import control program was designed in the 1970s, when few regulated products were imported into the US. Now FDA oversees nearly 2 million imported drug shipments per year, including tons of bulk APIs and cases of finished medicines. Although more than 80% of APIs come from abroad, especially from India and China, FDA inspections of foreign manufacturers have decreased to only a few hundred per year. It's costly and time-consuming for FDA to send inspectors around the world. These constraints result in short, preannounced site visits primarily related to the approval of new drug applications. FDA's antiquated information systems, moreover, are unable to track foreign manufacturers and inspections or exchange information between databases.

The Synthetic Organic Chemical Manufacturers Association petitioned FDA two years ago to tighten inspections of foreign drug-ingredient producers. The association claimed that lax regulation of those firms is luring more drug manufacturing operations overseas and creating an uneven playing field in the bulk-chemical manufacturing industry.

Reformers within and outside FDA seek a life cycle approach to import regulation that follows products through the supply chain and delivers assessments of product risk to border inspectors, compliance offices, and electronic screening systems. These and other proposals were included in an FDA Import Strategic Plan. The plan was developed four years ago, but never implemented because of a lack of funds to establish necessary IT systems and expand inspection staffs.


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