FDA Begins Product Approval Initiative: In an Ideal World, All New Medical Products Proven to Be Safe and Effective Would Be Approved the First Time They Were Considered by the Food and Drug Administration. A Company Would Submit an Application with All the Required Information, and the Agency Would Perform a Timely Review and Then Approve the Product for Marketing

Article excerpt

In reality, though, most medical products take more than one agency review cycle to be approved. Poorly designed studies and missing scientific information are just two of the possible reasons that applications often undergo multiple reviews that ultimately lengthen approval times.

If problems and deficiencies in product applications can be identified earlier, review times likely will fall and people will have access to new products more rapidly, FDA officials say. Nearly 5,000 new drugs, biologics, medical devices and animal drugs were approved in 2002. With fewer repeated reviews, called "cycles" by the FDA, there could have been even more.

Approvals that take more than one review to complete are not in the best interest of the public, the agency, or the company submitting the product application. From a public health standpoint, multiple-cycle reviews--when an application must be corrected and resubmitted a number of times before an FDA review can be completed--mean that safe and effective new products are not available to patients and health care providers in a timely manner. Multiple-cycle reviews prior to approval also can require substantial additional resources both for the FDA and the sponsor.

To help make innovative medical technologies available sooner, and to reduce the costs of developing safe and effective medical products, the FDA launched an initiative in January that offers guidance to companies it regulates so that they will have a better sense of what is expected on product applications. The initiative involves all four of the agency's medical product review centers (drugs, biologics, medical devices, and veterinary medicine) and focuses on:

* Reducing delays and costs in product approvals by avoiding multiple-review cycles

* Improving the review process through a quality systems approach to medical product review

* Expanding guidance documents to reduce uncertainty and increase efficiency for product development.

The agency has begun analyzing the root causes of product approvals that require more than one review cycle. With the reauthorization of the Prescription Drug User Fee Act (PDUFA), and the enactment of the similar Medical Device User Fee and Modernization Act (MDUFMA), the FDA expects to improve the quality and frequency of communications between the agency and drug, biologic, and medical device manufacturers. Both of these laws require fees paid by manufacturers to give the FDA the resources it needs to determine if a new drug, biologic or medical device should be approved.

In addition, the FDA will form working groups to oversee guidance development for priority areas such as treatments for cancer, diabetes and obesity.

Finding Solutions

Common problems with product applications significant enough to delay approval include unexpected safety issues or failure to demonstrate a drug or device's effectiveness. …