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The FDA wants drugmakers to change labeling on drugs approved through the accelerated pathway.

FDA to drugmakers: Tell doctors, patients not all drug approvals are permanent

By Virgil Dickson
Posted: March 25, 2014 - 3:00 pm ET

The Food and Drug Administration wants drugmakers to change labeling on drugs approved through the accelerated approval pathway so doctors and patients know such approvals could subsequently be revoked.

A new FDA guidance (PDF) seeks to clarify how drugs approved through the accelerated approval pathway should be labeled. The pathway in question is used to expedite the approval of medicines intended to treat serious or unmet needs. For instance, if there is a promising drug for a certain type of cancer that shows some early signs of benefit, that product could receive tentative accelerated approval.

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However, a drug cleared this way could lose approval if final analysis shows that the drug is actually not that effective or even harmful in some instances.

The FDA wants pharmaceutical companies with drugs approved on this pathway to update labeling to make it clear the limitations of usefulness of the drug and any uncertainty about anticipated clinical benefits.

Further these labels should note that the drug was approved under accelerated conditions based on limited data and note that further testing is ongoing, and that continued approval is contingent upon finding the expected benefit after full data is obtained.

If the drug ultimately is judged safe and effective, the company will be allowed to remove these advisories from the label.

The release of the guidance comes three years after the FDA revoked its approval of the breast cancer indication for Avastin after concluding that the drug has not been shown to be safe and effective for that use. The drug had been approved for metastatic breast cancer in February 2008 under the accelerated approval program after showing early signs that it could benefit patients battling the disease.

Avastin's risks included severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach and intestines.

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