In the latest bid to thwart the European Medicines Agency from proceeding with a new policy for disclosing clinical trial data, the pharmaceutical industry has openly challenged the effort by arguing the suggested approach would weaken safeguards for protecting patient privacy, undermine trust in the regulatory system, increase the risk data would be misinterpreted and weaken incentives for research.
The European Federation of Pharmaceutical Industries and Associations “has serious concerns about the EMA draft policy, which carries negative implications for public health in its failure to adequately protect the interests of patients and the research they benefit from,” the trade group says in a statement that is a prelude to a 26-page comment filed with the EMA (here is the EMA draft policy, the complete EFPIA document and here is an EFPIA summary).
The EMA draft policy, which was released in June, was designed in response to growing concerns that drugmakers have failed to sufficiently disclose trial data that includes important side effect information or allow independent researchers to verify results. Such concerns have figured prominently in scandals over the Vioxx painkiller, the Paxil antidepressant and Avandia diabetes pill in recent years.
In response, the EFPIA and PhRMA, the US trade group, this past July released voluntary guidelines outlining steps that drugmakers are willing to take to increase transparency, such as reaffirming a commitment to publish results regardless of outcomes and support publication. But critics say the proposal falls short because there are caveats that could ensure data is kept behind closed doors.
