On August 30, 2012, Janssen Pharmaceuticals, Inc. (“Janssen”) and its parent company, Johnson & Johnson, agreed to pay $181 million to 37 states and the District of Columbia to settle allegations that the marketing and advertising of its atypical antipsychotic products (Risperdal, Risperdal Consta, Risperdal M-Tab, and Invega) violated state consumer protection laws. The settlement imposes a number of restrictions on Janssen’s promotion of its atypical antipsychotic products moving forward. In a growing trend, these state restrictions are more proscriptive than the mandates contained in most Corporate Integrity Agreements entered into on the federal level. Although compliance with these provisions is limited to the parties involved, for the time period specified, and often only for the products that were the subject of the allegations, these settlements still provide insight into the thinking of state regulators. Some of the more interesting aspects of the Janssen agreement include:
- Restricts the Use of Patient Profiles: The settlement restricts the use of patient profiles to promote atypical antipsychotics. For example, the settlement requires that patient profiles highlighting specific symptoms include a statement on the same slide or page that the atypical antipsychotic is not approved by FDA to treat the selected symptoms and identifying the drug’s approved indications.
- Includes Marketing Personnel in the Financial Incentives Provision: The settlement prohibits financial incentives for Sales and/or Marketing personnel that motivate improper promotion, sales, and marketing of the atypical antipsychotics (note that “Sales” is broadly defined to include personnel who work with entities to secure placement of drugs on formularies or preferred drug lists).
- Restricts the Use of and Distribution of Off-Label Reprints: The settlement requires that Janssen comply with FDA Guidance concerning off-label reprints when disseminating such documents for its atypical antipsychotic products. It also prohibits Sales and Marketing personnel from disseminating such reprints unless the company has a pending filing with FDA for approval of the new indication described in the reprint. Notably, the settlement states that these provisions are not intended to prohibit the dissemination of reprints containing incidental references to off-label information. It does, however, require disclaimers in these situations.
- Prohibits Repeat Funding of Off-Label CME Programs: The settlement prohibits Janssen from knowingly funding the same CME program (after the initial grant award) if it discovers that the program speakers are promoting atypical antipsychotics for off-label uses.
- Limits Off-Label Samples, Even Upon Request: The settlement requires that Janssen only provide samples of atypical antipsychotics to HCPs whose clinical practice is consistent with the FDA-approved labeling for the product. It also directs the company to refer requests for samples from HCPs whose clinical practice is not consistent with the product labeling to the company’s Medical team, where the Medical representative can answer questions about the use of the product “and may provide [the caller] with samples only if appropriate (i.e., if the HCP requests the samples for an on-label use).”
Please note that this list of provisions is far from exhaustive. We encourage clients counseling in this area to carefully review the attached settlement agreements for other possible implications for their organizations.