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 Researchers compared the details companies made public in press
releases with confidential documents from the U.S. Food and Drug
Administration known as complete response letters, which explain why
a new medicine can’t be sold.
Often, companies made no announcement when a drug was rejected, or
omitted most of the reasons the FDA cited for denying approval, the
study found.
“Only a minority of the press releases clearly stated that receipt
of a complete response letter meant that marketing could not
commence, and most findings associating the drug with a higher
mortality rate went unmentioned,” lead study author Dr. Peter Lurie,
FDA associate commissioner for public health strategy and analysis,
said by email.
Lurie and colleagues analyzed 61 complete response letters issued
from August 2008 through June 2013, assessing what elements of the
letters, if any, companies disclosed in press releases.
When multiple letters were issued as part of the same application
process, the researchers only included the initial letter from the
FDA in the analysis, not subsequent ones issued after companies
responded to the original concerns.
If, however, companies received separate letters on the same new
drug for two different uses, the researchers counted those as
separate and included both in their analysis.
In 11 instances, or 18 percent of complete response letters,
companies didn’t issue any press release, the study found.
For 13 releases, none of the statements matched what was said in the
complete response letter.
About half of the time, the complete response letters cited
shortcomings in both safety and effectiveness. Out of 191 concerns
about effectiveness raised in the letters, drugmakers disclosed a
total of 30 in press releases, while companies shared 22 of 150
safety concerns.
Roughly half of the letters asked for new clinical trials to study
safety or effectiveness; and in 59 percent of these cases companies
disclosed this in a press release.
While seven letters reported that drugs had higher mortality rates
in treated people compared to those not treated with the medicine,
only one press release shared this detail.
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Publicly-traded companies, which may need to share details on the
drug rejection under securities regulations, were more likely to
issue press releases about complete response letters. These releases
also tended to include more statements that matched points made in
the letters.
Companies were also more likely to issue press releases when their
drug application was for the first in a new family of medicines.
Making the full contents of complete response letters public would
allow the FDA to increase transparency and combat misconceptions
about why regulators refuse approval for new drugs, Lurie said.
Doing this would probably require a change in FDA regulations, he
added
Public access to these letters would help patients better understand
the risks and benefits of medications, particularly when the
complete response letters are issued for new uses of previously
approved drugs, said Barbara Mintzes, a professor of pharmacy at the
University of Sydney and author of an editorial accompanying the
study in the journal BMJ.
Even though companies aren’t allowed to advertise drugs for
unapproved uses in the U.S., doctors are free to prescribe medicines
for what’s know as off-label use, Mintzes said by email.
“Doctors who are considering prescribing a drug for a specific use
would likely reconsider if they knew the FDA had rejected an
application for marketing for that specific use,” Mintzes said.
“Medicines are important treatments but they are capable of causing
harm as well as benefit, and harmful drug reactions are a leading
cause of death and hospitalizations,” she said.
SOURCE: http://bit.ly/1FbTJ50 BMJ, online June 10, 2015.
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