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Here’s a reasonable idea: Create an accelerated process to approve new, potentially life-saving drugs — and build in post-approval requirements to make sure the drugs really work. The FDA put in place the first part in the early 1990s, but hasn’t been so good at the follow-up, according to a GAO report out today.

In one case, a blood-pressure drug called ProAmatine was given conditional approval in 1996, but was never clearly proven to benefit patients. It’s still on the market, and several generic versions have been approved by FDA. The FDA has never withdrawn a drug given conditional approval, the report says.

As of December, 2008, the FDA had approved 90 drugs under the accelerated process, a majority of them for cancer and AIDS. Of 144 studies the FDA has required since the program launched in 1992, 64% were reported as completed. Some of the others were proceeding on schedule, but many have been “open for an extended period,” the report says.

The accelerated approvals are based on surrogate endpoints, which are measures used in drug studies that aren’t necessarily meaningful for patients. For example, studies may look at whether a cancer drug shrinks tumors. But a cancer drug may shrink tumors without extending a patient’s life or improving quality of life.

In its response to the report (included in Appendix V), the FDA says the program has “significantly improved [patients'] quality of life and survival.” And, the agency says, “in the vast majority of cases, the confirmatory trials have been or are being completed in a timely fashion, have confirmed clinical benefit, and have led to conversion to regular approval.”

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Continued here:
When FDA Fails to Follow-Up On Rapid Drug Approvals