Washington Report: Promises to Keep - Pharmaceutical Executive


Washington Report: Promises to Keep
Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules.

Pharmaceutical Executive

The Grassley–Dodd bill also creates a clinical trial results database to disclose summary results on most post-Phase I clinical trials. PhRMA responded by launching its own clinical study results database, which began posting data last year. But the voluntary program applies only to FDA-approved drugs, while the Senators want results from all trials, even those that never lead to an FDA application or approval.

Meanwhile, registries and results Web sites are proliferating around the world. French officials want all local trials to register on a national site. California lawmakers may require pharmaceutical companies to disclose all clinical results for any drug sold in the state. The World Health Organization is developing a "registry of registries," and the International Federation of Pharmaceutical Manufacturing Associations has established a search engine providing links to clinical trial registries around the world.

To avoid legislative mandates and public criticism, pharma companies are adopting a "disclose everything" approach. But that strategy could expose them to legal problems. In the United States, a company that releases early study results could be charged with promoting unapproved drug claims (in violation of FDA regulations) or with breaking Securities and Exchange Commission rules.

Clinical trial registration sets a framework for tracking study disclosure, but the debate has tended to blur these related but very different activities. Staffers at NLM fear that combining the clinicaltrials.gov/ registry with results disclosure could convey some kind of government imprimatur on the research; the NLM could link trial listings to study results or published literature but does not want to get into the business of vetting results.

Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at


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