Bristol-Myers SC ibb Pharmaceutical Rescm h Institute “PO. Box 4000 Princeton, NJ 08
609 252-5992Fax: 609 25:
4000 3
Laurie Smaldone, M.D. SeniorVice President Worldwide Regularoty Affairs
July
,200l
‘“&,
Dockets Management Branch Food and Drug Administration, HFA-305 5630 Fishers Lane, Rbom 1061 Rockville, MD 20857
Re: Docket No. OlD-0162 - Using FDA-Approved Pat Print Advertisements (66 Federal Register 20468; Apri
t Labeling in Consumer-Directed ?,2001)
Dear Sir or Madam: Bristol-Myers Squibb is a diversified global health and pt businesses in pharmaceuticals, consumer medicines, nutr leader in the research and development of innovative tha infectious diseases, neurological disorders and oncology. dedicated more than $1.8 billion for pharmaceutical resez company’s more than 4,300 scientists are committed to d therapeutic and preventive agents that extend and enhanc comprises more than 50 compounds under active develop Inal care company with principal nals and medical devices. We are a .esfor cardiovascular, metabolic, 12000 alone, Bristol-Myers Squibb I and development activities. The lver and develop best in class, uman life: Our current pipeline nt.
For these reasons, we are very interested in and well qua1 :d to comment on FDA’s proposed guidance on Using FDA-Approved Patient Labeling in msumer-Directed Print Advertisements. Summary of BMS Comments We support the U.S. FDA’s proposal to provide guidance aspects of the proposed guidance that require clarification cited below.
($I$$ A Bristol-Myers Squibb
this area. However, there are certain Id/or modification, which we have
vany
,c y
BMS COMMENTS:
Our primary concerns are as follows: X The proposed guidance should be revised to clarify th labeling that comprehensively addresses the product’! would be one, but not the only, way to satisfy the brie regulations. Consequently, we would like the propose addresses every risk included in an advertised drug’s brief summary requirement under the regulations. X Should 21 CFR 202.1(e)(3) (iii), be amended to speci patient labeling that comprehensively addressesthe p common risks satisfies the brief summary requiremen 202.1 (e)(3) (iii) only requires that a sponsor “disclose contraindication” (emphasis added). It would seem p this “new” standard specific to consumers be introduc The following paragraph in the proposed guidance is Because the regulations do not specify ho7 can use discretion in fulfilling the brief SUI (e)(3) (iii). Frequently, sponsors print in SI sections of the approved product labeling ( professional labeling, prescribing informal labeling is written for health professionals believes that this is one reasonable way to for print advertisements directed toward hl for consumers to understand. (emphasis ac In particular, the final sentence seems to imply that th differentiates between consumer and health professio disagree. As the regulation is currently constructed, u each specific side effect and contraindication in brief 202.1(e)(3) (iii), regardless of the audience to whom I FDA wants to create a new standard, we ask that they rulemaking procedures. We recommend deleting the statement “Omitting less those risks not likely to be caused by the product, ma labeling for its audience by making the more importal statement in the proposed guidance implies that the UI summary requirement (including an approach that dis contraindication) would be inferior. the use of FDA-approved patient lost serious and most common risks ummary requirement under the guidance to state that a sponsor who proved labeling would also fulfill the
,
that the use of FDA- approved luct’s most serious and most Currently, the regulation at 21 CFR tch specific side effect and lent that an addendum incorporating for regulatory action. nfusing and requires clarification: o address each risk, sponsors xtry requirement under 202.1 11 type, verbatim, the risk-related $0called the package insert, a, and direction circular). This ing medical terminology. FDA lfill the brief summary requirement th professionals, but may be difficult d) ,egulation at 21 CFR 202.1(e)(3) (iii) advertisements. We would relieve that a sponsor who discloses nmary still complies with 21 CFR advertisement is directed. If the. ) so through the appropriate
rious infrequent risks as well as ctually increase the usefulness of this -isks clearer”. Inclusion of this of other approaches to fulfill the brief uses & specific side effect and
X We believe that the following terms should be more qualitatively, to provide proper guidance for interpn -
trly defined, either quantitatively or on:
most serious
most common
Conclusion
major precautions frequently occurring
In summary, BMS recommends that the FDA refocus more clear definitions, what the FDA would not, objet approved patient labeling to fulfill the brief summary r (iii). The additional requirements implied in this guida required by regulation would be more properly introduce ‘BMS appreciates the opportunity to provide ‘comment an consideration to our recommendations. We would be pl information as may be requested.
ed guidance to articulate, with a company chooses to use FDAnt under 21 CFR 202.1 (e)(3) o beyond those currently nder rulemaking procedures. spectfully requests that FDA give d,to provide additional pertinent
Sincerely,
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