FDA, FTC Join Forces on Biologics Competition

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) on Monday issued a set of four joint goals to support a competitive US marketplace for approved biological products, outlining the next steps under each goal.

A new joint statement formalizes an agreement between the regulatory authorities intended to promote healthy competition in the biologics space, including through the adoption of biosimilars and interchangeable products. This builds on an ongoing collaboration.

By strengthening the partnership and interagency coordination, the move will help the agencies foster competition and deter anticompetitive behavior. The agencies cite anticompetitive reverse payment agreements, abusive repetitive regulatory filings, and misuse of restricted drug distribution programs as examples of anticompetitive behavior subject to regulatory action.

A shared focus is on false or misleading communications about biosimilars. The third goal outlines three steps set to tackle the issue within the agencies’ respective authority. Purchasers can compare products, prices, and benefits while patients and clinicians can make decisions based on accurate information when such communications are truthful and non-misleading.

“Both FDA and FTC support competitive markets for biologics and have serious concerns about false or misleading statements and their negative impacts on public health and competition,” the joint statement says. The agencies will leverage each other’s purview to fill in gaps in oversight.

FDA issued draft guidance in tandem with the joint statement that builds on the joint goal on taking appropriate action against false or misleading communications. In a Q&A format, the draft guidance addresses questions that may come up in developing promotional materials.

The push for competition underscores the need for achieving a balance between access and costs. Biological products create cost savings for consumers but are more costly to develop.

“While these therapies are critical for patients, biological products contribute significantly to drug costs, as they are often far more complex to develop than other drugs,” FDA Commissioner Stephen Hahn said. “Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”

Congress enacted the Biologic Price Competition and Innovation Act of 2010 with the goal of advancing similar benefits of competition to the Hatch-Waxman Amendments but for biologics.

Generic drugs generated about $2 trilling in cost savings for patients over the past decade thanks to the Hatch-Waxman Amendments of 1984, according to the Association for Accessible Medicines. FDA research suggests biosimilars have the potential to create similar cost savings post-market entry, even though the maturity of the US market for such products is still ongoing.

Business and intellectual property concerns have been attributed to the delayed launch of some of the 26 biosimilars with FDA approval. “Practices in biologics markets are delaying the availability of biosimilar products, thereby depriving patients of the benefits of competition, including lower prices and increased innovation,” FTC Chairman Joseph Simons said Monday.

Joint goals call for educational materials to address misperceptions that may exist about approved biosimilars’ safety or effectiveness and collaboration on future public outreach efforts.

FTC will review patent settlement agreements involving biologics for antitrust violations. FTC and FDA will assess whether additional information-sharing arrangements are warranted under the goal of deterring tactics used to prevent or impede access to reference products' samples.

An FDA-FTC public workshop on a competitive marketplace for biosimilars is set for March 9.