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U.S. Department of Health and Human Services

Drugs

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Small Business Assistance: Charging for Investigational New Drugs

[Code of Federal Regulations]
[Title 21, Volume 5, Parts 300 to 499]
[Revised as of April 1, 1999]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.7]

[Page 61-62]
 
                        TITLE 21--FOOD AND DRUGS
 
           DEPARTMENT OF HEALTH AND HUMAN SERVICES--Continued
 
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 312.7  Promotion and charging for investigational drugs.

    (a) Promotion of an investigational new drug. A sponsor or 
investigator, or any person acting on behalf of a sponsor or 
investigator, shall not represent in a promotional context that an 
investigational new drug is safe or effective for the purposes for which 
it is under investigation or otherwise promote the drug. This provision 
is not intended to restrict the full exchange of scientific information 
concerning the drug, including dissemination of scientific findings in 
scientific or lay media. Rather, its intent is to restrict promotional 
claims of safety or effectiveness of the drug for a use for which it is 
under investigation and to preclude commercialization of the drug before 
it is approved for commercial distribution.
    (b) Commercial distribution of an investigational new drug. A 
sponsor or investigator shall not commercially distribute or test market 
an investigational new drug.
    (c) Prolonging an investigation. A sponsor shall not unduly prolong 
an investigation after finding that the results of the investigation 
appear to establish sufficient data to support a marketing application.

[[Page 62]]

    (d) Charging for and commercialization of investigational drugs--(1) 
Clinical trials under an IND. Charging for an investigational drug in a 
clinical trial under an IND is not permitted without the prior written 
approval of FDA. In requesting such approval, the sponsor shall provide 
a full written explanation of why charging is necessary in order for the 
sponsor to undertake or continue the clinical trial, e.g., why 
distribution of the drug to test subjects should not be considered part 
of the normal cost of doing business.
    (2) Treatment protocol or treatment IND. A sponsor or investigator 
may charge for an investigational drug for a treatment use under a 
treatment protocol or treatment IND provided: (i) There is adequate 
enrollment in the ongoing clinical investigations under the authorized 
IND; (ii) charging does not constitute commercial marketing of a new 
drug for which a marketing application has not been approved; (iii) the 
drug is not being commercially promoted or advertised; and (iv) the 
sponsor of the drug is actively pursuing marketing approval with due 
diligence. FDA must be notified in writing in advance of commencing any 
such charges, in an information amendment submitted under Sec. 312.31. 
Authorization for charging goes into effect automatically 30 days after 
receipt by FDA of the information amendment, unless the sponsor is 
notified to the contrary.
    (3) Noncommercialization of investigational drug. Under this 
section, the sponsor may not commercialize an investigational drug by 
charging a price larger than that necessary to recover costs of 
manufacture, research, development, and handling of the investigational 
drug.
    (4) Withdrawal of authorization. Authorization to charge for an 
investigational drug under this section may be withdrawn by FDA if the 
agency finds that the conditions underlying the authorization are no 
longer satisfied.

(Collection of information requirements approved by the Office of 
Management and Budget under control number 0910-0014)

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 19476, May 22, 1987]