327 



- 84 



"(n) th« case of any prescrlDt1on drug distributed or offered 

 for salt 1n any State, unless the manufacturer, packer, or 

 distributor thereof includes In all advertisements and other 

 descriptive printed matter issued or caused to be Issued by the 

 manufacturer, packer or distributor with respect to that drug a 

 true statement of (1) the established name as defined in section 

 502(e), printed prominently and in type at least half as large 

 as defined in Section S02(e) printed prominently and In type at 

 least half as large as that used for any trade or brand name, 

 thereof (2) the formula showing quantitatively each Ingredient 

 of such drug to the extent required for labels under Section 

 502(e), and (3) such information in brief sutimary relative to 

 the side effects, contra Indications, and effectiveness as shall 

 be required in regulations which shall be Issued by the 

 Secretary in accordance with the procedure specified in Section 

 701(e) of this Act..." 



Pursuant to these sections FOA h&s also promulgated extensive regulations 

 governing the advertising of prescription drugs 21 CFR Part 202, 

 "Prescription Drug Advertising." 



In addition to numerous other advertising restrictions and requirements, 

 subsection (d) 6 states that an advertisement for a prescription drug "is 

 false, lacking In fair balance, or other wise misleading or other wise in 

 violation of section 502(n) of the act, if It: 



1) Contains a representation or suggestion not approved or 



permitted for use In the labeling, that a drug Is better, more 

 effective, useful in a broader range of conditions or patients 

 (as used in the section "patients* means humans), has f»i9r, or 

 less incidence of, or less serious side effects or 

 contraindications than has been demonstrated by substantial 

 evidence or substantial clinical experience whether or not such 

 comer i SOPS are made or not such comparisons are made with 

 directly or through use of published or unpublished literature, 

 quotations, or other references, 



1i) Contains a drug comparison that represents or suggests that a 

 drug is safer or more effective than another drug in some 

 particular when it has not been demonstrated to be safer or 

 more effective in such particular by substantial evidence or 

 substantial clinical experience." 



