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FDA Consumer magazine
May-June 2003
Table of Contents
By Carol Lewis
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.
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:
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.
Common problems with product applications significant enough to delay approval include unexpected safety issues or failure to demonstrate a drug or device's effectiveness.
"While an application might be administratively complete; that is, all components are present," says senior scientific reviewer Mitchell J. Shein of the FDA's Division of Cardiovascular Devices, "if the information in the application is not adequately detailed, we might not be able to perform a favorable review. We want to make sure that companies provide adequately robust information."
A manufacturer may need to conduct additional studies involving more people or different types of people, or for a longer period of time. Manufacturing issues, such as a facility not being prepared for inspection, are also reasons that product approval may be delayed or denied. Any manufacturing deficiencies found would need to be corrected before approval.
Mary H. Parks, M.D., deputy director of the FDA's Division of Metabolic and Endocrine Drug Products, says that close communication with the agency during critical stages of drug development or when significant problems arise reduces the chances that the application would have to go through more than one review cycle.
"Companies are made aware of the possibility of FDA meetings to help sponsors better prepare their applications," she says.
Although the FDA generally has been meeting its PDUFA review time goals (six months for priority product applications and 10-12 months for standard applications), actual time to approval can be much longer when an application goes through multiple cycles.
"It also bears repeating that the reviewers don't have just one application to work on," says Enid Galliers, chief of the project management staff in the FDA's metabolic and endocrine drug products division. Galliers says that submission of a complete and well-organized application, as a result of timely communication between sponsors and the agency, allows for a more efficient review cycle.
Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., says that by making the FDA's requirements for approval clearer from the start, reduction in approval times and costs will build excellence and predictability into the product development process.
But, says McClellan, "Improvement in the rate of single-cycle approval must result from better product development, not lower standards." The quality systems approach and the specific guidance McClellan envisions "should help establish an improved regulatory paradigm--one that will improve the development of innovative medical technology and reduce the costs of technology development, while maintaining FDA's traditional high standard of consumer protection."