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

In Washington This Month
The legislators also instruct the agency to work with pharmacies and patient groups to improve the MedGuide program, reflecting pharmacists' fears of being overwhelmed by the program's growing volume of patient leaflets on specific drugs. And the bill seeks a more efficient FDA process for vetting long-established medicines that were never approved by the agency and have been targeted for enforcement action in recent years.

FDA also must produce a long list of studies and reports about everything from the safety of Sanofi Aventis's Ketek to microbial resistance. The final legislation omits an earlier provision to expand drug reimportation, but still requires FDA to analyze how well it oversees the foreign manufacture of active pharmaceutical ingredients (APIs).

Undue influence?

In addition to dropping the user-fee program for DTC advertising, the funding bill includes other measures that reflect ongoing concerns on Capitol Hill about pharmaceutical companies' influence on FDA policies. Congress used the bill to remind FDA to reduce the number of advisory committee members with conflicts-of-interest. And it took a big swipe at the Reagan–Udall Foundation, which was authorized by FDAAA, by stipulating that FDA cannot use any appropriated funds to support this new organization.

Joining forces to rescue FDA
That curb reflects the concerns of Rep. Rosa DeLauro (D-CT), chair of the House Appropriations Subcommittee that oversees FDA. DeLauro fears that Reagan–Udall will permit drug manufacturers to shape FDA actions related to drug safety in a way similar to how the Tobacco Institute supported research refuting health concerns about tobacco. FDAAA allows FDA to provide as much as $1.25 million for this public–private entity to support critical path initiatives. But when FDA officials complied with FDAAA by naming a blue-ribbon board of directors for the foundation, DeLauro flexed her muscle by inserting a funding hold in the final appropriations bill.

Though FDA officials hope to assuage DeLauro's concerns, the rift is likely to slow down Reagan–Udall initiatives such as helping to establish a new active surveillance system for drugs, another project supported by FDAAA. Former FDA commissioner Mark McClellan, who was named the chair of Reagan–Udall, is a leading advocate of using health system databases and advanced IT systems to detect and analyze drug safety signals earlier and faster to prevent safety problems and facilitate new drug development. Establishing such a system is no easy task and will require new data standards and collaborative efforts. These are tasks that could be accomplished by such a public–private foundation.

Dropping the DTC user fees is an unusual step for Congress. Even though industry payments account for almost one-fourth of FDA's $2.2-billion FY 2008 budget, members of Congress usually are eager to tap this ready source of revenue to fund FDA programs. In fact, FDAAA boosted drug user fees by another $25 million for each of the next five years to support additional drug safety initiatives, and Congressional leaders have proposed new legislation that would raise millions more through fees on food and drug imports.


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