Product News and Recalls

Op-ed says more accountability needed for drug approvals

A recent opinion piece in the New York Times calls for more public access to the clinical data that government agencies such as the U.S. Food and Drug Administration use for making policy about medications.

Authors Peter Doshi and Tom Jefferson write that drug or medical device manufacturers are required only to share their data with regulators, who treat the data as secret, and not with independent researchers or academics.

That policy, they write, requires members of the public to take it on faith that regulators are making the right decisions, without being able to evaluate the data that serves as the basis for those decisions.

And according to Doshi and Jefferson, that faith isn’t always warranted.

For example, they mention government stockpiling of an anti-influenza drug at more than $1.5 billion of taxpayer expense, despite clinical data published in medical journals indicating that the drug is no more effective that aspirin.

Another incident that has recently raised public concerns about the FDA’s ability to make objective decisions concerns the birth control pill Yasmin, and other contraceptives such as Yaz, Beyaz and Ocella that contain the compound drospirenone.

In December, an FDA panel voted narrowly to keep those pills on the market, despite evidence that they carry a higher risk of blood clots than other available types of birth control pills. But subsequent investigation showed that four members of the panel – enough to sway the vote – had financial or professional ties to the pills’ manufacturer.

See the New York Times piece here: http://www.nytimes.com/2012/04/11/opinion/drug-data-shouldnt-be-secret.html?_r=2&partner=rss&emc=rss%3F