Amit Patel, PharmD
Associate Director, Regulatory Advertising and Promotion
Johnson & Johnson Pharmaceutical Services, L.L.C. 
430 Route 22
East Bridgewater, NJ 08807

RE:  NDA No. 21-976 PREZISTA™ (darunavir) Tablet
       MACMIS ID#17310

Dear Dr. Patel:

This letter notifies Johnson & Johnson Pharmaceutical Services, L.L.C.  (Johnson & Johnson), which markets PREZISTA™ (darunavir) Tablet (Prezista) on behalf of Tibotec (a wholly-owned subsidiary of Johnson & Johnson), that, as part of its monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S.  Food and Drug Administration (FDA) has reviewed Johnson and Johnson’s sponsored link on internet search engines (e.g., Google.com) for Prezista.  The sponsored link cited in this letter is misleading because it makes representations and/or suggestions about the efficacy of Prezista, but fails to communicate any risk information associated with the use of this drug.  In addition, the sponsored link for Prezista inadequately communicates the drug’s indication and fails to include the required established name.  Thus, the sponsored link misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations.  See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).

Background

According to its FDA-approved product labeling (PI):

Prezista is associated with a number of risks, as reflected in the Contraindications, Warnings and Precautions, and Adverse Reactions sections its PI.

Omission of Risk Information

Promotional materials, other than reminder pieces, which include the name of the drug product but do not include indications or other representations or suggestions relative to the drug product (see 21 CFR 200.200, 201.100(f), 202.1(e)(2)(i)), are required to disclose risk and other information about the drug.  Such materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials.  The sponsored link presents the following claim:

•  HIV/AIDS important info
   Learn more about your options.
   For both patients and physicians.
   www.prezista.com

This sponsored link makes representations and/or suggestions about the efficacy of Prezista, but fails to communicate any risk information.  For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug.

By omitting the most serious and frequently occurring risks, the sponsored link misleadingly suggests that Prezista is safer than has been demonstrated.  We note that this sponsored link contains a link to the product’s website.  However, this is insufficient to mitigate the misleading omission of risk information from this promotional material.

Inadequate Communication of Indication

The sponsored link for Prezista provides a very brief statement about what the drug is for; however, this statement is incomplete and misleading, suggesting that Prezista is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience.  Specifically, the sponsored link misleadingly broadens the indication for Prezista by implying that all patients with HIV/AIDS are candidates for Prezista therapy (“HIV/AIDS important info…For both patients and physicians.  www.prezista.com”), when this is not the case, and by failing to reveal that the drug is not indicated for use as monotherapy.  Rather, Prezista is co-administered with ritonavir and with other antiretroviral agents for the treatment of HIV infection in adult patients and pediatric patients 6 years of age and older.  Additionally, the PI contains several points to consider when initiating Prezista therapy in treatment-experienced adult and pediatric patients with HIV, none of which are conveyed in the link.

Failure to Use Required Established Name

The sponsored link fails to present the full established name for Prezista, despite the requirement to do so.  See 21 CFR 201.10(g)(1) & 202.1(b)(1).

Conclusions and Requested Action

For the reasons discussed above, the sponsored link misbrands Prezista in violation of the Act and FDA regulations.  See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).

DDMAC requests that Johnson & Johnson immediately cease the dissemination of violative promotional material for Prezista, such as those described above.  Please submit a written response to this letter on or before April 9, 2009, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) in use for this drug as of the date of this letter, identifying which of these materials contain violations such as those described above, and explaining your plan for discontinuing use of such materials.

Please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD, facsimile at 301-847-8444.  In all future correspondence regarding this matter, please refer to MACMIS # 17310 in addition to the NDA number.  We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list.  It is your responsibility to ensure that your promotional materials for Prezista comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely,
 

Shefali Doshi, M.D.
Regulatory Review Officer
Division of Drug Marketing,
Advertising, and Communications