[e-drug] Drugs for life threatening illness

["Robert Leedham" <RKLeedham@mail.pharmacy.wisc.edu>]

E-DRUG: Drugs for life threatening illness
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Hello:

In the response to the AIDS crisis in the 1980s, the U.S. Food and Drug Administration (FDA) 
developed regulations to new drug marketing approval for Serious or Life-Threatening 
Illnesses.

Since December 11, 1992, there has been Subpart H -- Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses as part of its Title 21 Code of Federal Regulations (CFR) PART 314 Applications for FDA Approval to Market a New Drug (NDA). In response to the AIDS crisis in the USA, FDA wanted a mechanism to approve certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to,or intolerant 
of, available therapy, or improved patient response over available therapy).

This part of the regulations included:

?	Approve may be based on a surrogate endpoint or on an effect on a clinical endpoint 
other than survival or irreversible morbidity;
?	Approval may have restriction on drug distribution for specific safety concerns presented by the drug product to assure safe use;
?	has procedures to withdraw drugs if proven ineffective or more effective drugs are 
available;
?	requires mandatory postmarketing safety reporting (which is otherwise largely voluntary);
?	limits promotional materials; and,
?	has provisions for termination of NDA approval, if requirements. 

See the following website:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfrCFRSearch.cfm?CFRPart=314&showFR=1&subpartNode=21:5.0.1.1.4.8
[URL will need repair]

'What kind of therapeutical category falls in the definitions of life threatening illnesses?'  

The FDA approvals under Subpart H is based on the disease itself and not a specific therapeutical category.

What kind of disease falls in this category? 

Primarily, AIDS, oncology and infectious diseases usually qualify for Subpart H NDA approval.

I hope this explanation was helpful.

R.K. Leedham, Jr., R.Ph., M.S., Ph.D. Student
Division of Social and Administrative Pharmacy
Box 78, Rennebohm Hall, School of Pharmacy
University of Wisconsin-Madison
777 Highland Ave.                
Madison, WI  53705-2222
Phone: (608) 262-3637 (Department)
        (608) 262 4723 (Graduate Office)
FAX: 	(608) 262-5262
Robert Leedham <RKLeedham@mail.pharmacy.wisc.edu>