Direct To Consumer Television Advertisements FDAAA DTC Ad Pre Dissemination Review Program TH 45A UCM295554

User Manual: TH-45A

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Guidance for Industry
Direct-to-Consumer Television
Advertisements — FDAAA
DTC Television Ad Pre-
Dissemination Review Program
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60
calendar days of publication in the Federal Register of the notice announcing the availability of
the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments
should be identified with the docket number listed in the notice of availability that publishes in
the Federal Register.
For questions regarding this draft document contact (CDER) Marci Kiester at 301-796-1200, or
(CBER) the Office of Communication, Outreach, and Development at 301-827-1800 or 800-835-
4709.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
March 2012
OPDP
Guidance for Industry
Direct-to-Consumer Television
Advertisements — FDAAA
DTC Television Ad Pre-
Dissemination Review Program
Additional copies are available from:
Office of Communications
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue, Bldg. 51, room 2201
Silver Spring, MD 20993-0002
(Tel) 301-796-3400
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or
Office of Communication, Outreach, and Development (HFM-40)
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
(Tel) 301-827-1800 or 800-835-4709
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
March 2012
OPDP
Table of Contents
I. INTRODUCTION............................................................................................................. 1
II. BACKGROUND ............................................................................................................... 1
III. CATEGORIES OF TV ADS SUBJECT TO PRE-DISSEMINATION REVIEW ..... 2
IV. HOW WILL FDA NOTIFY SPONSORS OF THE REQUIREMENT TO SUBMIT
A TV AD FOR PRE-DISSEMINATION REVIEW?.................................................... 4
V. CONTENTS OF A COMPLETE PRE-DISSEMINATION REVIEW PACKAGE .. 5
A. What materials should I include in a pre-dissemination review package?...............................5
B. What should not be included in a pre-dissemination review package?.....................................6
C. How are incomplete pre-dissemination review packages handled? ..........................................6
VI. FREQUENTLY ASKED QUESTIONS AND ANSWERS ........................................... 7
A. How long does FDA have to review a television ad under section 503B and when does the
clock start?......................................................................................................................................7
B. What happens if FDA is not able to complete its review within the 45-day time frame?........7
C. Will FDA continue its review if I decide to disseminate my TV ad before receiving FDA
comments, but after the clock has run?.......................................................................................7
VII. ENFORCEMENT............................................................................................................. 7
A. What happens if I do not submit a TV ad for review that is required under section 503B or
submit a TV ad for review and disseminate the ad before the 45-day comment period
without waiting for comments from FDA?..................................................................................7
B. What happens if I disseminate my TV ad without incorporating the Agency’s comments? ..8
APPENDIX: CENTER-SPECIFIC SUBMISSION PROCEDURES ..................................... 9
CDER.......................................................................................................................................................9
CBER.....................................................................................................................................................10
Contains Nonbinding Recommendations
Draft – Not for Implementation
1 Guidance for Industry1
2 Direct-to-Consumer Television Advertisements —
3 FDAAA DTC Television Ad Pre-Dissemination Review Program
4
5
6 This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current
7 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to
8 bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of
9 the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA
10 staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call
11 the appropriate number listed on the title page of this guidance.
12
13
14
15 I. INTRODUCTION
16
17 This guidance is intended to assist sponsors of human prescription drugs, including biological
18 drug products approved under section 351 of the Public Health Service Act, by describing how
19 FDA plans to implement the requirement for the pre-dissemination review2 of direct-to-
20 consumer television advertisements (TV ads) according to section 503B of the Federal Food,
21 Drug, and Cosmetic Act (the FD&C Act). The guidance describes the types of TV ads that FDA
22 intends to be subject to this provision, explains how FDA will notify sponsors that an ad is
23 subject to the requirement of review under section 503B, and describes the general and Center-
24 specific procedures sponsors should follow to submit their TV ads to FDA for pre-dissemination
25 review in compliance with section 503B of the FD&C Act.
26
27 FDA’s guidance documents, including this guidance, do not establish legally enforceable
28 responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should
29 be viewed only as recommendations, unless specific regulatory or statutory requirements are
30 cited. The use of the word should in Agency guidances means that something is suggested or
31 recommended, but not required.
32
33 II. BACKGROUND
34
35 On September 27, 2007, the President signed into law the Food and Drug Administration
36 Amendments Act of 2007 (FDAAA) (Public Law No. 110-85). FDAAA gives FDA the authority
37 to “. . . require the submission of any television advertisement for a drug . . . not later than 45 days
38 before dissemination of the television advertisement” (section 901(d)(2), codified at 21 U.S.C.
39 353b).
1 This guidance has been prepared by the Office of Prescription Drug Promotion (OPDP) in the Center for Drug
Evaluation and Research (CDER) in cooperation with the Advertising and Promotional Labeling Branch (APLB) in
the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration.
2 The term “pre-dissemination review” is used throughout the guidance to refer to review under section 503B of the
FD&C Act, which is entitled “Prereview of Television Advertisements.”
Contains Nonbinding Recommendations
Draft – Not for Implementation
40
41 In conducting a review of a TV ad under this section, FDA may make recommendations with
42 respect to information included in the label of the drug on:
43
44 changes that are necessary to protect the consumer good and well-being, or that are consistent
45 with prescribing information for the product under review; and
46 statements for inclusion in the advertisement to address the specific efficacy of the drug as it
47 relates to specific population groups, including elderly populations, children, and racial and
48 ethnic minorities, if appropriate and if such information exists.
49
50 21 U.S.C. 353b(b)(1) and (2).
51
52 FDA is issuing this guidance to communicate the categories of TV ads it generally intends to
53 require sponsors to submit under this provision, to explain how it will notify sponsors that FDA
54 is requiring review under section 503B for ads for a particular drug or group of drugs, and to
55 provide sponsors with recommendations for the information they need to properly submit these
56 ads to the Agency for pre-dissemination review.
57
58
59 III. CATEGORIES OF TV ADS SUBJECT TO PRE-DISSEMINATION REVIEW
60
61 The Agency intends to require sponsors to submit TV ads for pre-dissemination review in the
62 following categories:
63
64 Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or
65 expanded approved indication for any prescription drug
66 Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and
67 Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the
68 FD&C Act)
69 Category 3: All TV ads for Schedule II controlled substances
70 Category 4: The first TV ad for a prescription drug following a safety labeling update
71 that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of
72 its labeling
73 Category 5: The first TV ad for a prescription drug following the receipt by the sponsor
74 of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites
75 a TV ad or causes a TV ad to be discontinued because the TV ad contained violations
76 similar to the ones cited in the enforcement letter
77 Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-
78 dissemination review provision
79
80 These categories reflect a risk-based approach that will enable the Agency to leverage its limited
81 resources to best protect the public health by ensuring that certain high risk and high impact TV
82 ads accurately and effectively communicate key information about advertised products,
83 including their major risks and indications. Specifically, these categories allow the Agency to
84 review and provide comments on TV ads for prescription drugs with particularly serious risks,
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85 and to review and provide comments on TV ads at times when feedback on the risk and
86 indication communication in the ad is particularly critical, including when a product is first
87 advertised on TV and after a product has received a significant safety labeling update or a new or
88 expanded indication.
89
90 Category # 1: FDA intends to review and comment on the first TV ad for a prescription drug or
91 the first TV ad for a new or expanded indication for an already-approved product. This will
92 allow us to provide feedback on the major statement (i.e., the presentation of risk information in
93 a broadcast ad), which sponsors can apply to both the initial ad and future ads. FDA can also
94 identify any issues with the presentation of the product’s indication and, where applicable, the
95 product’s specific efficacy in population subgroups, and provide feedback relevant to both
96 current and future ads.
97
98 Categories # 2 and # 3: FDA intends to review all TV ads for certain prescription drugs with
99 particularly serious risks relative to benefits — specifically, products with REMS with elements
100 to assure safe use and products that are Schedule II controlled substances. FDA believes it is
101 critically important that the risks associated with such products be appropriately communicated
102 in all promotion, and intends to review all TV ads for such products to help ensure that this
103 occurs.
104
105 Category # 4: FDA intends to review and comment on the first TV ad for a prescription drug
106 following a significant safety labeling update to the product’s FDA-approved prescribing
107 information (PI). This will allow us to provide feedback on the “major statement” for that
108 product to help ensure that new risk concepts are communicated appropriately in the submitted
109 ad and in future ads for the product. FDA understands that certain safety labeling supplements
110 can be submitted as “Changes Being Effected” supplements (CBE supplements), and that
111
112 sponsors may begin distribution of the product using the modified labeling contained in the
supplement upon receipt of the CBE supplement by FDA.3 If a sponsor chooses to disseminate a
113 TV ad while such a CBE supplement is pending review and approval by FDA, FDA encourages
114 the sponsor to submit the TV ad under the voluntary advisory review process to the appropriate
115 group (OPDP or APLB). Once FDA has approved the CBE supplement (resulting in a
116 significant safety update to the product’s FDA-approved labeling), FDA intends to require the
117 sponsor to submit its next TV ad for the product to FDA for pre-dissemination review, even if
118 the same or a substantially similar TV ad was submitted voluntarily prior to the FDA approval of
119 the CBE supplement, to ensure that the ad remains consistent with the labeling as approved.
120
121 Category # 5: FDA intends to review and comment on the first TV ad for a prescription drug
122 after a sponsor receives an enforcement letter from FDA for its promotion of that product that
123 either cited a TV ad or caused a TV ad to be discontinued because the TV ad contained
124 violations similar to the ones cited in the enforcement letter. In either of these cases, FDA
125 intends to review the next TV ad for the product before it is publicly aired to ensure that the ad is
126 not false or misleading and that the ad does not contain violations that are the same or similar to
127 those cited in the enforcement letter.
3 See 21 CFR 314.70(c)(6) and 601.12(f)(2).
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128
129 Category # 6
130 In addition, FDA may notify a sponsor that a TV ad for a product is subject to the pre-
131 dissemination review provision in the FD&C Act if such pre-dissemination review is deemed
132 necessary from a public health perspective. This would be done on a case-by-base basis after
133 considering the risks associated with particular products. In such a case, a sponsor will be
134 notified in writing of our decision to apply this provision to its product and of the length of time
135 that the pre-dissemination review requirement will be in effect for its product.
136
137 Generally, sponsors have the option of submitting any proposed prescription drug television ad
138 to FDA for advisory review before publicly disseminating the ad (see 21 CFR 202.1(j)(4)). In
139 this way, sponsors can benefit from FDA’s input on whether or not ads are accurate, balanced,
140 and nonmisleading before they disseminate the ads. This voluntary submission process also
141 gives sponsors an opportunity to address any problems before the TV ads are shown to the
142 public, improving the quality of the ads. This voluntary submission process is still available to
143 sponsors. However, if a sponsor has been notified that a TV ad for one of its products is subject
144 to the pre-dissemination review provisions in section 503B of the FD&C Act, it will be required
145
146 to submit this TV ad for pre-dissemination review.
147 FDA understands that sponsors subject to the 503B pre-dissemination review provision may
148 revise their TV ads after receiving comments from the Agency, but before disseminating the ads.
149 FDA does not expect a sponsor to resubmit its draft TV ad for pre-dissemination review if the
150 revisions made to the ad are in response to the Agency’s comments and do not introduce new
151
152 claims, concepts, or creative themes into the TV ad. If a sponsor does wish to request additional
comments on such a TV ad, it should do so under the voluntary advisory submission process.4
153 However, if a sponsor revises a draft TV ad following pre-dissemination review under section
154 503B to add new claims, concepts, or creative themes into the TV ad, the sponsor will be
155 required to resubmit the TV ad to the Agency for pre-dissemination review following the
156 procedures outlined in this guidance.
157
158 IV. HOW WILL FDA NOTIFY SPONSORS OF THE REQUIREMENT TO SUBMIT
159 A TV AD FOR PRE-DISSEMINATION REVIEW?
160
161 FDA intends to notify drug sponsors of the requirement to submit their TV ads for pre-
162 dissemination review in several different ways. For drugs approved in the future and for
163 approved drugs for which an expanded indication is approved in the future (Category 1), for
164 approved drugs that fall under Categories 4 and 5 as described in this guidance, and for any other
165 drugs for which FDA determines pre-dissemination review of TV ads is required (Category 6),
166 FDA intends to notify sponsors in the letter approving the application or supplement, in the
167 approval of the labeling update, in the enforcement letter, or in other correspondence. For drugs
168 already approved prior to the issuance of this guidance that fall under Categories 1, 2, and 3,
4 Visit http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090159.htm
and
www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMaterials/uc
m164120.htm for current information regarding the advisory review submission process.
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169 FDA intends to publish a notice in the Federal Register notifying sponsors that their products
170 will be subject to pre-dissemination review in accordance with section 503B of the FD&C Act.
171 However, if a sponsor is developing a TV ad for a product that falls into one of the categories
172 described above and has not yet received written notification, we recommend that the sponsor
173 submit the TV ad for pre-dissemination review as described in this guidance.5
174
175
176 V. CONTENTS OF A COMPLETE PRE-DISSEMINATION REVIEW PACKAGE
177
178 For FDA to meaningfully review and provide recommendations on TV ads submitted under the
179 section 503B pre-dissemination review provision, the Agency should receive certain information
180 and materials in addition to the ad itself, such as the advertised product’s current approved
181 labeling and any references a sponsor is relying on to support claims made in an ad. This section
182 of the guidance outlines what should be included in a sponsor’s pre-dissemination review
183 package. Complete pre-dissemination review packages should be sent to either CDER or CBER,
184 depending on which Center regulates the product the TV ad addresses. The following
185 recommendations apply to all pre-dissemination review packages for TV ads sent to FDA.
186 Specific details regarding submissions to CDER and CBER are provided in the Appendix.
187
188 A. What materials should I include in a pre-dissemination review package?
189
190 A sponsor should include the following in all pre-dissemination review packages for a TV ad:
191
192 1. A cover letter that:
193 Provides the following subject line: Pre-Dissemination Review Package for a
194 Proposed TV Ad for [Proprietary Name/Established Name (dosage form) (for drugs),
195 or Trade name/Proper name (for biologics)] Subject to 503B of the FD&C Act
196 Includes the NDA or STN number
197 Provides the name of the proposed TV ad
198 Lists the contents of the pre-dissemination review package and the number of copies
199 provided of each item contained in the pre-dissemination review package (see
200 Appendix for details on the number of copies to submit to each Center)
201 Provides a sponsor contact’s name, title, address, phone, fax, and email
202 2. Annotated storyboard of the proposed TV ad to show which references support which
203 claims
5 For current contact information for OPDP, visit
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090142.htm. For
current contact information for APLB, visit
www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMaterials/uc
m164120.htm.
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204 3. The most current FDA-approved prescribing information (PI) and, if applicable, the FDA-
205 approved patient labeling or Medication Guide with annotations cross-referenced to the
206 storyboard
207 A sponsor should also include other appropriate documentation, if any of the following apply:
208 4. Annotated references to support product claims not contained in the PI, cross-referenced
209 to the storyboard
210 5. Verification that a person identified in a TV ad as an actual patient or health care
211 practitioner is an actual patient or health care practitioner and not a model or actor; and/or
212 Verification that a spokesperson who is represented as a real patient is indeed an actual
213 patient; and/or
214 Verification that an official translation of a foreign language TV ad is accurate
215 6. Annotated references to support disease or epidemiology information, cross-referenced to
216 the storyboard
217 7. A video of the TV ad in an acceptable format,6 if available. FDA cannot provide final
218 comments on the acceptability of a TV ad without viewing a final recorded version in its
219 entirety. FDA understands that some sponsors may wish to receive comments from the
220 Agency before producing a final recorded version of the ad. In such situations, sponsors
221 can submit a pre-dissemination review package without a final recorded version of the ad,
222 but once the final recorded version is produced, it will need to be submitted to the
223 Agency for pre-dissemination review.
224
225 B. What should not be included in a pre-dissemination review package?
226
227 Materials unrelated to a proposed TV ad being submitted for pre-dissemination review should
228 not be included in the pre-dissemination review package. For example, do not include other
229 draft promotional materials in the pre-dissemination review package. In addition, only one
230 proposed TV ad should be submitted per pre-dissemination review package.
231
232 C. How are incomplete pre-dissemination review packages handled?
233
234 Pre-dissemination review packages that are missing any of the elements in section V(A) above or
235 that fail to follow the specific details for submissions to CDER or CBER as provided in the
236 Appendix are considered incomplete. If FDA receives an incomplete package, we will:
237
238 Inform the sponsor that the submission is incomplete
239 Provide the reason(s) that the package is incomplete
240 Request a submission package that contains the missing materials
6 Visit http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090159.htm
and
www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMaterials/uc
m164120.htm for current information regarding acceptable formats.
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241
242 Note that the 45-day review time frame (see below) does not begin until a complete pre-
243 dissemination review package is received.
244
245 VI. FREQUENTLY ASKED QUESTIONS AND ANSWERS
246
247 A. How long does FDA have to review a television ad under section 503B and when
248 does the clock start?
249
250 Under section 503B, FDA may require that a TV ad be submitted to FDA for review not later
251 than 45 days before the sponsor intends to disseminate the ad (21 U.S.C. 353b(a); see also 21
252 U.S.C. 333(g)(3)(C)). The 45-day review clock for proposed DTC TV ads subject to the pre-
253 dissemination review provision begins when CDER or CBER has received a complete pre-
254 dissemination review package from a sponsor.
255
256 B. What happens if FDA is not able to complete its review within the 45-day time
257 frame?
258
259 FDA will notify the sponsor if the Agency is not able to provide comments within the 45
260 calendar day time frame. FDA’s notification will include an estimate of the date on which FDA
261 expects to provide its comments. In such situations, the sponsor should determine whether it will
262 wait for FDA’s comments before disseminating the TV ad or whether it will disseminate the TV
263 ad without waiting for FDA’s comments. The sponsor should notify FDA of its decision. Once
264 the 45-day review time has elapsed, there is no specific legal consequence resulting from
265 disseminating the proposed TV ad without waiting for FDA’s comments see section VII.A).
266 However, once an ad is disseminated, the sponsor is at risk of enforcement action if the ad
267 violates the FD&C Act and implementing FDA regulations.
268
269 C. Will FDA continue its review if I decide to disseminate my TV ad before receiving
270 FDA comments, but after the clock has run?
271
272 No. If a sponsor decides to disseminate the proposed TV ad before receiving FDA’s comments,
273 but after the 45-day clock has run, FDA will discontinue its 503B review. As noted above, if the
274 ad is disseminated, the sponsor is at risk of enforcement action if the ad violates the FD&C Act
275 and implementing FDA regulations.
276
277
278 VII. ENFORCEMENT
279
280 A. What happens if I do not submit a TV ad for review that is required under section
281 503B or submit a TV ad for review and disseminate the ad before the 45-day
282 comment period ends, without waiting for comments from FDA?
283
284 Under section 301(kk) of the FD&C Act (21 U.S.C. 331(kk)), dissemination of a television
285 advertisement without complying with section 503B is a prohibited act. This prohibited activity
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286 can be enjoined (21 U.S.C. 332(a)) and be subject to criminal penalties (21 U.S.C. 333(a)). In
287 addition, if the Agency assesses civil monetary penalties to the sponsor because the TV ad is
288 false or misleading (21 U.S.C. 333(g)), in determining the civil monetary penalty amount, FDA
289 will take into account the fact that the sponsor failed to submit a TV ad for pre-dissemination
290 review that was required to be submitted under section 503B (21 U.S.C. 333(g)(3)(B)), and will
291 take into account the fact that the sponsor, after submitting the ad, disseminated the ad before the
292 end of the 45-day comment period (21 U.S.C. 333 (g)(3)(C)). FDA may also take into account
293 the fact that the sponsor failed to submit the TV ad for pre-dissemination review or disseminated
294 it after submission but before the 45-day comment period without waiting for comments from
295 FDA if it decides to issue an untitled letter or Warning letter to the sponsor for the TV ad.
296
297 B. What happens if I disseminate my TV ad without incorporating the Agency’s
298 comments?
299
300 As previously noted, under section 301(kk) of the FD&C Act (21 U.S.C. 331(kk)), dissemination
301 of a television advertisement without complying with section 503B is a prohibited act. Under
302 section 503B(e), FDA may require specific disclosure of a serious risk listed in the labeling of a
303 drug, and may require the ad to include the date of the product’s approval for a period of up to 2
304 years after that approval, where the absence of either of these pieces of information would render
305 the ad false or misleading. Failure to incorporate these specific required disclosures is a
306 prohibited activity under section 301(kk) that can be enjoined (21 U.S.C. 332(a)) and be subject
307 to criminal penalties (21 U.S.C. 333(a)).
308
309 As a result of its review, in addition to requiring disclosures as described above, FDA may also
310 provide comments indicating other elements of the TV ad that it believes would result in the ad
311 being false or misleading, or otherwise violating the FD&C Act or implementing regulations. If
312 the Agency assesses civil monetary penalties to the sponsor because it has disseminated a TV ad
313 that is false or misleading (21 U.S.C. 333(g)), in determining the civil monetary penalty amount,
314 FDA will take into account the fact that the sponsor disseminated the TV ad without
315 incorporating the Agency’s comments (21 U.S.C. 333(g)(3)(D)). FDA may also take into
316 account the fact that the sponsor disseminated the TV ad without incorporating the Agency’s
317 comments if it decides to issue an untitled or Warning letter.
318
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319
320 APPENDIX: CENTER-SPECIFIC SUBMISSION PROCEDURES
321
322 CDER
323
324 1. Forms
325
326 No specific form is to be used. Please submit the materials in accordance with the
327 recommendations in this guidance.
328
329 2. Number of Copies
330
331 How many copies should I submit?
332
333 For CDER OPDP pre-dissemination reviews, submit the following number of copies in
334 pre-dissemination review packages for a proposed TV ad:
335 If a video is being provided, 2 copies in an acceptable format
336 12 copies of all other materials discussed in V(A)(2)-(6)
337
338 As an alternative, all materials discussed above can be submitted on a CD.
339
340 3. Address
341
342 For products regulated in CDER (OPDP), submit proposed DTC TV ads (pre-
343 dissemination review packages and amendment packages) to:
344
345 Project Manager
346 Office of Prescription Drug Promotion
347 Food and Drug Administration
348 5901-B Ammendale Road
349 Beltsville, MD 20705-1266
350
351 It is very important to specify on both the outer package and the cover letter that the
352 contents concern a pre-dissemination review package subject to section 503B of the
353 FD&C Act. Follow the recommendations discussed in section V(A) of this guidance for
354 the cover letter. Include a large type reference line on the outer package that indicates the
355 package is a 503B pre-dissemination review package, such as the following:
356
357 o OPDP Pre-Dissemination Review Package as Required by Section 503B of
358 the FD&C Act
359
360 Any questions for OPDP may also be addressed to an OPDP project manager by phone at
361 301-796-1200.
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362
363 CBER
364
365 1. Forms
366
367 For pre-dissemination review packages for biologics under the purview of CBER (sent to
368 APLB), include the most current version of Form FDA 2253, with Line 13 checked as
369 “Part 1/Draft.” Note that this form is not to be included with CDER submissions (see
370 above).
371
372 2. Number of Copies
373
374 For CBER APLB pre-dissemination reviews, submit the following number of copies in
375 each pre-dissemination review package for a proposed TV ad:
376 If a video is being provided, 2 copies in an acceptable format
377 2 copies of all other materials discussed in V(A)(2)-(6)
378
379 3. Address
380
381 For products under the purview of CBER (APLB), submit proposed TV ads (pre-
382 dissemination review packages and amendment packages) to:
383
384 Advertising and Promotional Labeling Branch, HFM-602
385 Center for Biologics Evaluation and Research
386 Food and Drug Administration,
387 1401 Rockville Pike, suite 200N
388 Rockville, MD 20852
389
390 It is very important to specify on both the outer package and the cover letter that the
391 contents concern a pre-dissemination review package subject to section 503B of the
392 FD&C Act. Follow the recommendations discussed in section V(A) of this guidance for
393 the cover letter. Include a large type reference line on the outer package that indicates the
394 package is a 503B pre-dissemination review package, such as the following:
395
396 o APLB Pre-Dissemination Review Package as Required by Section 503B of
397 the FD&C Act
398
399 Any questions for APLB may also be addressed to APLB by phone at 301-827-3028.
400
401
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