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Transparency debate extends to rejected drug applications

Claims from the BMJ made in new published study

BMJ logoPharma companies often fail to disclose why their medicines have been rejected by the US FDA, which this could be detrimental to public health says the British Medical Journal (BMJ).

A study published in the journal looked at the complete response letters (CRLs) issued by the FDA when a marketing application is rejected and compared it to the press release issued by the company, if it chose to make a public statement on the rejection.

The researchers examined 61 CRLs sent by the FDA between August 2008 and June 2013 and found that the press release released by the company matched the reasons cited by the FDA in just 14% of cases. 

All told, 85% of safety concerns went unreported by companies, as did 84% of efficacy concerns and 96% of reservations about trial design or conduct. In 11 cases no PR was released at all, according to the team led by Peter Lurie, associate commissioner of the FDA's Office of Public Health Strategy and Analysis.

Drugmakers did a little better reporting when new clinical trials were required - cited in 32 CRLs and mentioned in press statements in 59% of cases - but while seven letters reported higher mortality rates in treated participants "only one associated press release mentioned this fact", report the authors.

"When it comes to non-approvals, the [study] shows that commercial confidentiality continues to trump public health," writes Barbara Mintzes of the University of Sydney in an editorial accompanying the research paper.

"Secrecy concerning non-approval of drugs has a similar potential to harm the public as trials with negative results that fail to see the light of day," she adds, noting that drugs are often approved in one country but not another and so the information from one regulator is relevant to treatment decisions elsewhere.

While the non-publication of clinical trial results has been at the top of the list of contentions between the pharma industry and transparency advocates, greater disclosure of regulatory decisions has seen less activity.

Back in 2010 the topic was raised by the FDA in a document on transparency issued for public comment, which noted that where it refuses to approve a marketing application is should publish the letter "which contains the reasons for issuing the letter."

The recommendation by the agency's Transparency Task Force does not seem to have been taken further in the interim, however, and the FDA 's position is now at odds with other regulators including the European Medicines Agency (EMA), publishes its reasons for rejecting applications in European Public Assessment Reports (EPARs).

An earlier loophole that allowed companies to withdraw EMA applications likely to fail and avoid disclosure was closed in 2012, according to the BMJ editorial.

Lurie et al suggest three possible solutions to the transparency gap: ask sponsors to release the CRLs, require them to publish more completes press releases; or require the FDA to make all CRLs public. The latter course would however require a change in FDA regulations, they point out. 

Benefits of disclosure would include "better informing the development of new drugs, facilitating a richer public health discourse, and counteracting misconceptions regarding FDA's reasons for denial of applications," they conclude.

Article by
Phil Taylor

15th June 2015

From: Regulatory



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