By: Susan Heavey, Reuters
WASHINGTON, 27 August 2010 – The U.S. Food and Drug Administration is cracking down on use of certain clinical trials that show a new drug is no worse than another already on the market, according to a government report released on Friday.
Such trials, known as non-inferiority trials, are used when drugmakers want to compare their experimental product to another one that is already FDA-approved. By showing that their new drug is no worse than another, it can also show some potential benefits such as fewer side effects.
But some critics question the benefit of approving a new drug if it is simply shown to be no worse than something already available to patients, especially if any additional benefits are slight.
The report, conducted by the Government Accountability Office and released by a bipartisan group of U.S. lawmakers, found the FDA is taking a tougher line in the wake of industry guidelines it issued in March.
“GAO’s review of FDA’s guidance showed that the agency has become more conservative in allowing evidence from non-inferiority trials to demonstrate a drug’s effectiveness,” the report said.
“First, FDA has limited the indications for which these trials may be used. Second, the agency has also become more rigorous in its review of evidence from non-inferiority trials,” according to the GAO, which analyzed such trials looked at by the FDA between 2002 and 2009.
Additionally, the GAO said that repeatedly using non-inferiority trials for certain kinds of drugs can lead to “biocreep,” in which successive approvals lead to drugs that are less and less effective and eventually “no more effective than a placebo.”