Magazine article FDA Consumer

Speedier Approval Rules

Magazine article FDA Consumer

Speedier Approval Rules

Article excerpt

Final rules to speed the approval of drugs and biologics for people with serious or life-threatening diseases, such as cancer, AIDS, or Alzheimer's disease, went into effect Jan. 11, 1993.

The regulations, published in the Dec. 11, 1992, Federal Register, establish procedures for FDA to approve a therapy based on "surrogate endpoints" or markers when the product provides a meaningful benefit over currently available therapies. Such endpoints might include laboratory tests or physical signs that do not in themselves constitute a clinical effect, but which qualified scientists judge are likely to correspond to real benefits to the patient.

The use of surrogate endpoints for efficacy permits approval earlier than the traditional agency-required endpoints, such as relief of disease symptoms or prevention of disability and death.

When a product is approved based on surrogate endpoints, FDA will require the therapy's sponsor to agree to continue or undertake human studies to confirm that the chug is clinically effective. The new rules provide for a streamlined withdrawal process if post-marketing studies do not verify the therapy's clinical benefit, if there is new evidence that the product is not safe and effective, or if other circumstances arise that make its speedy withdrawal necessary.

The new rules also enable FDA to approve a therapy more quickly but restrict or modify its use. For example, distribution might be restricted to facilities or physicians with special training or experience; or distribution might be conditional on the performance of specified medical procedures. …

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