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Date: Friday, March 29, 1996
FOR IMMEDIATE RELEASE
Contact: FDA Press Office (301)443-1130

ACCELERATING APPROVAL AND EXPANDING ACCESS

Clinton Administration Increases Availability of Cancer Drug

Under reforms announced today, the Clinton Administration expects to substantially cut development and review times for promising new cancer drugs. These changes, it is expected, will reduce drug development times by at least a year and will cut FDA review time for cancer drugs almost in half, from 12.4 months to 6 months. At a White House ceremony, President Clinton, Vice President Gore and HHS Secretary Donna E. Shalala outlined this initiative to make new therapies available sooner to American patients. The announced reforms in the regulation of cancer drugs at the Food and Drug Administration are part of the Vice President's ongoing "reinventing government" efforts. These efforts represent another example of the Clinton Administration's commitment to streamline the regulatory process while still maintaining critical public health protections. Specific measures announced today include:

Accelerated Approval for Cancer Treatments: At present, the FDA relies mainly on improvements in a patient's survival time or quality of life for marketing approval. Starting today, the FDA will begin to rely more on partial responses, such as shrinkage of a tumor, when considering drugs for accelerated approval. Through simpler clinical trials, manufacturers can more quickly demonstrate these partial responses than they can improvements in survival and quality of life. By basing accelerated approval on these partial responses, and allowing more definitive data to be developed after approval, FDA will make more cancer therapies available to patients more quickly.
Expanded Access to Drugs Approved Abroad: For patients with life-threatening illnesses such as cancer, FDA has devised several programs that provide patient access to promising therapies that have not yet completed clinical evaluations. The FDA will now begin proactively soliciting sponsors of cancer drugs approved abroad to submit these drugs for use in the existing programs. This will help make experimental therapies available to patients shortly after they are approved in other countries even if they are early in their development within the United States.
Cancer Patient Input: FDA relies on advisory committees to provide outside expertise on agency policy and product decisions; the recommendations of these committees often become the basis of FDA decisions. While many of the committees currently include a consumer representative, FDA will now ensure that an individual who has personal experience with the specific cancer being studied be included as an ad hoc member of each cancer-therapy committee.
Fewer Applications for Additional Uses of Cancer Drugs: Currently, many researchers ask FDA to review "supplemental" applications to study unapproved uses for approved cancer drugs, even if they do not intend to market the drug for the new use. In many circumstances, these additional submissions are unnecessary. The FDA will make clear that it does not require such submissions, thereby eliminating any confusion about the necessity of the filing. Investigators can therefore devote more of their time to the challenges of cancer research.

The Clinton Administration currently has the authority to carry out all of these reforms and will begin to do so immediately.

A more detailed explanation of the initiatives announced today is available in "Reinventing the Regulation of Cancer Drugs," a report from the Vice President's National Performance Review.

Background on Cancer: In 1996, more than 1.3 million people will be diagnosed with cancer in this country. Every day, more than 1,500 Americans of all ages, races, and incomes will die because of these deadly diseases. But because of our extraordinary breakthroughs in therapies, early detection, and prevention, there are 7 million Americans today who can call themselves cancer survivors.

FDA Approval of Cancer Drugs: In 1994 and 1995, 12 new drugs for cancer patients or new uses for existing agents were approved in the United States.

The average time to review and approve cancer drugs has been 12.4 months between 1990 and 1995. The following is a list of FDA's most recent approvals:

	1994 
	Taxol		Refractory breast cancer				
	Navelbine	Advanced non-small-cell lung cancer	
							
	1995 
	Zinecard	Chemotherapy protectant				
	Aredia		Bone metastases in multiple myeloma	
	Casodex		Advanced prostate cancer				
	Doxil		Kaposi's sarcoma					
	Vesanoid	Acute promyelocytic leukemia			
	Ethyol		Chemotherapy protectant				
	Zoladex		Advanced breast cancer				
	Photofrin	Esophageal cancer					
	Arimidex	Advanced breast cancer