Markey Statement on GlaxoSmithKline Clinical Trials Data
Lawmaker has introduced TEST Act to ensure disclosure of critical information about clinical trials and complete information about products on market
WASHINGTON, D.C. – Congressman Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, released the following statement after drug maker GlaxoSmithKline announced it would make data from its clinical trials publicly available. In July Glaxo pleaded guilty to criminal charges after withholding safety information from US regulators about its drugs Paxil and Avandia. Rep. Markey recently introduced H.R. 6272, the Trial and Experimental Studies Transparency (TEST) Act to close clinical trial loopholes and bring certainty and transparency to life-saving research studies.
“It shouldn’t take a criminal settlement to gain access to potentially life-saving clinical trial information,” said Rep. Markey. “I introduced the TEST Act earlier this year to create more robust transparency in clinical trials. Requiring human subject trial data be posted to a public database will help maintain the trust of clinical trial participants and avoid putting people unnecessarily at risk.”
The TEST Act updates and expands the clinical trial registry data bank – clinicaltrials.gov. Rep. Markey’s bill will:
- Require all interventional biomedical studies on humans to be registered with the database before the first participant is enrolled in the trial
- Strengthen reporting requirements so that results from all covered trials are posted on the database within one year of the completion of the trial.
- Provide for delayed submission of results (up to two years after trial completion) for trials on medical interventions that have never before been approved for any use
- Instruct the Secretary of HHS to undergo a rulemaking to require foreign trials that are used to support an application for marketing in the U.S. to comply with the registration and reporting requirements of the database
- Instruct NIH and the FDA to provide a report to Congress regarding the implementation and compliance with the database requirements.