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  5. CooperSurgical, Inc. - 613339 - 02/12/2021
  1. Warning Letters

WARNING LETTER

CooperSurgical, Inc. MARCS-CMS 613339 —

Product:
Drugs
Recipient:
Recipient Name
Holly Sheffield
Recipient Title
President
CooperSurgical, Inc.

75 Corporate Drive
Trumbull, CT 06611
United States

Issuing Office:
The Office of Prescription Drug Promotion (OPDP)

United States

WARNING LETTER

RE: NDA 018680
PARAGARD (intrauterine copper contraceptive)
MA 628

Dear Ms. Sheffield:

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a direct-to-consumer video “sponsored by PARAGARD” (intrauterine copper contraceptive) (Paragard). This promotional communication, a video, entitled “Paragard: Family Planning During The Pandemic[,]” was presented on WBTS’s The Hub Today.1 The video was submitted as a complaint to the FDA Bad Ad Program. The video is false or misleading in that it presents efficacy claims for Paragard, but fails to communicate any risk information associated with its use. Thus, the video misbrands Paragard within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and makes its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1(e)(5). In addition, this promotional communication was not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i). These violations are concerning from a public health perspective because this promotional communication creates a misleading impression about the safety of Paragard.

Background

Below are the indication and summary of the most serious and most common risks associated with the use of Paragard.2 According to the FDA-approved product labeling (PI):

Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.

Paragard is contraindicated in pregnancy or suspicion of pregnancy; in women with abnormalities of the uterus resulting in distortion of the uterine cavity, acute pelvic inflammatory disease, postpartum endometritis or postabortal endometritis in the past 3 months, known or suspected uterine or cervical malignancy, uterine bleeding of unknown etiology, untreated acute cervicitis or vaginitis or other lower genital tract infection, conditions associated with increased susceptibility to pelvic infections, Wilson’s disease, a previously placed IUD or IUS that has not been removed, or a hypersensitivity to any component of Paragard including to copper or any of the trace elements present in the copper component of Paragard. The PI also contains warnings and precautions regarding ectopic pregnancy, risks with intrauterine pregnancy, sepsis, pelvic inflammatory disease and endometritis, embedment, perforation, expulsion, Wilson’s disease, bleeding pattern alterations, magnetic resonance imaging (MRI) safety information, and medical diathermy. Adverse reactions reported with use of Paragard include anemia, backache, dysmenorrhea, dyspareunia, expulsion (complete or partial), prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis.

Prior Communication

OPDP has expressed concerns regarding promotional materials for Paragard in a previous letter. On July 25, 2019, OPDP sent CooperSurgical, Inc. (CSI) an Untitled Letter for a Paragard Direct-to-Consumer television advertisement (2019 Untitled Letter) that omitted important risk information. CSI appears to be promoting Paragard without presenting the serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP.

False or Misleading Risk Presentation

Promotional materials misbrand a drug if they are false or misleading with respect to risk. The determination of whether promotional materials are misleading includes, among other things, not only representations made or suggested in promotional materials, but also failure to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the materials.

The video begins with a voiceover statement, “This segment is sponsored by Paragard,” while simultaneously presenting the logo and proprietary and established names for Paragard along with the Paragard URL. The remainder of the video features a physician being interviewed and includes claims and representations about the use and/or benefits of Paragard. For example, superimposed text (SUPER) is included throughout the video, “FAMILY PLANNING DURING THE PANDEMIC PARAGARD’S NON-HORMONAL OPTION” (bolded emphasis original). However, the video fails to communicate any risk information about the product. We note that viewers are referred to “WWW.PARAGARD.COM” for further information about Paragard; however, this does not mitigate the complete omission of risk information from the video. By omitting the risks associated with Paragard, the video fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety. This misleading presentation is particularly concerning from a public health perspective due to the serious and potentially life-threatening risks associated with the drug, such as those contained in the WARNINGS AND PRECAUTIONS section of Paragard’s PI.

Failure to Submit Under Form FDA-2253

FDA regulations require any labeling or advertising devised for promotion of the drug product to be submitted at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current professional labeling. A copy of the video was not submitted to OPDP under cover of Form FDA-2253 at the time of initial dissemination as required by 21 CFR 314.81(b)(3)(i).

Conclusion and Requested Action

For the reasons discussed above, the video misbrands Paragard within the meaning of the FD&C Act and makes its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1(e)(5). Furthermore, CSI did not comply with 21 CFR 314.81(b)(3)(i).

This letter notifies you of our concerns and provides you with an opportunity to address them. OPDP requests that CSI cease any violations of the FD&C Act. Please submit a written response to this letter within 15 days from the date of receipt, addressing the concerns described in this letter, listing all other promotional communications (with the 2253 submission date) for Paragard that contain representations like those described above, and explaining any plan for discontinuing use of such communications, or for ceasing distribution of Paragard.

Failure to adequately address this matter may lead to regulatory action. If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 days from the date of receipt of this letter.

Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter. OPDP recommends that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand Paragard; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). Corrective communication(s) should be free of promotional claims and presentations. To the extent possible, corrective communication(s) should be distributed using the same media, and generally for the same duration of time and with the same frequency as the promotional communication(s) identified in the opening paragraph of this letter.

The concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations. It is your responsibility to ensure compliance with each applicable requirement of the FD&C Act and FDA implementing regulations.

Please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to MA 628 in addition to the NDA number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter.

Sincerely,
{See appended electronic signature page}
Robert Dean
Director
Division of Advertising & Promotion Review 2
Office of Prescription Drug Promotion

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This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.
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/s/
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1 This video is available on the internet at https://www.nbcboston.com/news/national-international/paragardfamily-planning-during-the-pandemic/2207154/ (uploaded on October 5, 2020 and last accessed February 12, 2021).

2 This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional piece cited in this letter.

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