Enhancing Drug Safety - Pharmaceutical Technology

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Enhancing Drug Safety
User-fee legislation will require more testing and data disclosure to prevent unsafe drug use.

Pharmaceutical Technology

Mandatory disclosure of research results. A key goal of the new policy is to link clinical-trial registration to results information. Many pharmaceutical companies already do that voluntarily, but the legislators want a more comprehensive approach. Although the details remain sketchy, policymakers expect that results listings will include published studies and all FDA information about the drug (except proprietary trade secrets) such as the approved product label, review package, and related safety information.

A thorny issue is whether sponsors can comply with registration and results-disclosure policies without drawing charges of illegal promotion. Manufacturers fear that posting information about the indication and study design of a test product could be seen as promoting unapproved uses. Similarly, requiring sponsors to provide summaries of a study in lay language could be regarded as making false claims. Pharmaceutical companies believe that such summaries are of limited value and that clinical-trial results should be written primarily for a medical and scientific audience.

Reduction of conflicts of interest. The legislation reflects Congressional concerns that too many members of FDA advisory committees have financial links to industry. Although policymakers recognize that these panels can benefit from experts' input, despite their conflicts, the legislation seeks to limit the number of waivers used to permit such testimony. Congress also wants FDA to more actively solicit scientists and medical experts without financial ties to pharmaceutical companies to improve the advisory process and ensure that outside advice about safety issues is objective.

Improving IT

A prime initiative for reducing drug-safety problems is to modernize FDA's electronic information system. User fees have supported improvements in the agency's information technology (IT) infrastructure for new-drug review and oversight. Now PDUFA IV will provide additional funds to establish an all-electronic regulatory-submission-and-review environment during the next five years. The envisioned system will allow manufacturers to send applications electronically with automated crosslinks to previously submitted data, and FDA reviewers will be able to retrieve all relevant submissions and use tools to search and analyze data. The goal is a system that can handle the two-way transmission of regulatory correspondence and other information.

A modern IT system also would improve FDA's current system for receiving and analyzing adverse-event reports from manufacturers, health professionals, and patients. Moreover, Congress supports FDA efforts to build a more robust active-surveillance system to identify emerging safety problems instead of relying on spontaneous adverse-event reports. Additional resources will permit FDA to contract with government health programs and private health plans to access population-based epidemiological data about millions of patients, which can greatly expand postmarketing drug surveillance. More collaboration with government, academic organizations, and with the Centers for Education and Research on Therapeutics, will enable FDA to learn more about how a drug works in real-world, postmarket circumstances, including the extent and outcomes of off-label drug uses. The legislation notes, though, that such programs should include procedures to protect the privacy of individuals.

PDUFA funds also will support an increase in FDA staff epidemiologists, safety evaluators, and programmers to better use internal and external IT resources. New research will provide a better understanding of the role of epidemiologic analysis and the use of databases in evaluating drug safety.

Scrutinizing drug ads

A new addition to PDUFA is a user-fee program to enhance FDA's review of direct-to-consumer (DTC) broadcast drug advertising. Companies that sponsor TV commercials for prescription drugs have agreed to pay $6.3 million in 2008 to increase the staff of FDA's Division of Drug Marketing, Advertising, and Communications, and other review offices. FDA's goal for the next five years is to provide advisory reviews of TV commercials in 45 days and to rereview previously submitted ads in 30 days.

Some members of Congress sought to ban consumer advertising of new drugs for months or years after a new product comes to market, noting that even a more efficient and comprehensive review of DTC ads would remain voluntary. Instead, legislators agreed to authorize stiffer fines and penalties for companies that fail to ensure accuracy and balance in drug advertising. All parties will be watching closely to see if misleading commercials contribute to drug-safety concerns.

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

Additional resources

The Coalition for a Stronger FDA

The FDA Alliance

House Energy and Commerce Committee


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