The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement on Monday, February 3, 2020 (here) regarding their collaborative plans to advance competition in the biologics market. This joint effort is intended to address misinformation and anti-competitive behavior that may impede competition between biologic drug products. A significant focus of this effort will be on industry actions and communications that delay the development or availability of biosimilar products or undermine public confidence regarding the safety or efficacy of FDA-approved biosimilar products.
This newly established coordinated effort by these two government agencies is an expansion of their long-term (65+ year) working relationship and an extension of the FDA’s Biosimilars Action Plan published in July 2018 (here).
The public stands to benefit from increased competition in the biologic drug product market through increased availability of therapeutic options and significant reductions in the cost of biologic medicines.
The coordinated activities by the FDA and FTC are intended to reduce gaming of the system and other means of delaying market competition including anticompetitive behavior by the pharmaceutical industry such as reverse payment agreements, abusive repetitive regulatory filings (e.g., Citizen Petitions), and misuse of restricted drug distribution programs (e.g., Risk Evaluation and Mitigation Strategy (a.k.a. REMS)).
Overall, the FDA and FTC have jointly outlined four goals:
- Coordination to promote greater competition in biologic markets through education of consumers and healthcare providers about biosimilars and holding public meetings to discuss competition for biologics
- Deterrence of behavior that impeded access to samples needed for development of biologics and biosimilars (Hopefully, more details on how such anticompetitive behavior will be punished will be revealed at the public workshop described below.)
- Taking action against false or misleading communications about biologics (The FDA has authority over labeling and promotional materials, and the FTC has authority over unfair or deceptive acts or practices.)
- The FTC will review patent settlements between reference product manufacturers and biosimilar manufacturers to ensure that they do not include any anticompetitive reverse payments that slow or delay the introduction of more affordable medicines.
A public workshop titled “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars” regarding the interagency efforts to facilitate competition is being jointly organized by the FDA and FTC (here) will be held on March 9, 2020 at the White Oak campus in Silver Spring, Maryland.
Topics for discussion at the workshop will include:
- S. Biosimilar Markets and FDA Approval Process;
- Enforcement Activities by FDA and FTC;
- The Benefits of Competition; and
- Improving Stakeholder Engagement: Education and Access.
If you wish to speak at the meeting, you must register (here) by February 24, 2020. Persons seeking to attend but not speak at the public workshop must register (here) by March 4, 2020. Public comments regarding the workshop must be submitted to the docket (here) by April 9, 2020.
Hopefully, this coordinated effort by the FDA and FTC will have a significant and meaningful impact on the challenges to establishing a competitive environment for biologic drug products and will provide for more affordable biologic drugs for the American public.