The REMS Industry Consortium, Inc. (RIC) is a nonprofit organization that brings together the perspectives of organizations that sell, or anticipate selling, prescription drugs or biologics subject to Risk Evaluation and Mitigation Strategies (REMS).
The RIC seeks to:
- foster and encourage two-way communication between manufacturers/REMS sponsors and FDA
- discuss and clarify challenges faced by industry sponsors and the FDA
- identify best practices for REMS throughout the development, review, and management lifecycle
- provide the FDA with a "sounding board" to solicit feedback on REMS
- collectively explore vendor participation and capabilities in REMS
Antitrust Compliance Statement
It is the policy of the REMS Industry Consortium, Inc. (“RIC”) to comply in all respects with United States federal and state antitrust laws, as well as applicable international antitrust laws. Antitrust laws serve to preserve and promote competition for the benefit of consumers. Violations of antitrust laws can have detrimental consequences both to companies who violate those laws, and to consumers impacted by those violations.
RIC intends to conduct itself in such a manner that it avoids any potential antitrust exposure. All members agree they will comply in full to RIC’s antitrust guidance and antitrust laws in general. To comply with the antitrust laws, discussions during meetings, or otherwise between or among, members should avoid competitively sensitive topics. Prohibited topics include, but are not limited to, prices, allocating territories, boycotts, discussing specific R&D, sales or marketing plans, or any company’s confidential product, development, or production strategies or any other statement or exchange of information that may be construed as anti-competitive. Some anti-competitive conduct, such as price-fixing, bid rigging, and market or customer allocation agreements, automatically is presumed to be illegal and the absence of any actual harm to competition will not be a defense against a claim for such conduct, and members must strictly avoid this conduct. In particular, RIC and its members are prohibited from agreeing to:
- Fix or set prices for selling products or services;
- Allocate geographic markets or customers;
- Rig bids, rotate bids, or otherwise distort the bid process;
- Boycott customers, suppliers or vendors;
- Set levels of production or output; or
- Conspire to exclude competitors or customers.
Participants in RIC meetings should understand they have an obligation to terminate any discussion, seek legal counsel’s advice, or, if necessary, terminate any meeting if the discussion might be construed to raise antitrust risks. All RIC meetings and activities are held for the purpose of transacting the appropriate business of RIC and to further RIC’s goals, and to the furthest extent possible, are overseen by RIC’s outside counsel. All meetings and activities of RIC must be conducted in a manner consistent with this policy.