FTC to Hold Workshop on Prescription Drug Competition

The Federal Trade Commission (FTC) has announced a November 8 workshop that will focus on competition issues related to prescription drug marketing.

The workshop, titled Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics, will feature keynotes by acting FTC Chairperson Maureen K. Ohlhausen and FDA Commissioner Scott Gottlieb, MD.

The workshop will address issues related to both the Hatch-Waxman Act (which provides a framework for generic entry into the small-molecule drug market) and the Biologics Price Competition and Innovation Act (which provides a pathway for biosimilar product entry). The first session of the workshop will focus on generic drug markets and factors that could preclude entry of generic competitors after an innovator product’s patents have expired, and will include discussion of non-price factors that can impact market entry. The second session will evaluate the role of intermediaries including pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs) in drug prices for consumers.

“Competition is key to containing prescription drug costs. During the last decade, generic drugs have saved Americans more than $1.67 trillion,” said Ohlhausen. “In light of concerns about rising drug prices, it's critical [that] we identify barriers that may prevent drugs from entering the market, even after applicable patent protections have expired.”

In announcing his participation in the panel on Twitter, Gottlieb said that he looked forward to working together with the commission:

In a statement, Gottlieb elaborated further, saying that he welcomed the opportunity to take part in the FTC’s workshop as a way to help identify obstacles to competition, and that “I am committed to doing all we can under the FDA’s authority to help reduce the burden on consumers, so that no patient is ever priced out of access to a medicine they need to cure a disease or maintain their health.”

Such cooperation between the FDA and FTC is a welcome development for those hoping for greater regulatory attention paid to prescription drug pricing. Elizabeth Jex, JD, attorney advisor for the FTC’s office of policy planning said at September’s Association for Accessible Medicines Biosimilars Council Conference 2017 meeting in Washington, DC, that “There’s been an uptick of coordination” between the agencies under current leadership, and that the FTC might be close to disclosing more information about collaborative efforts.

Jex said that “The commission and I share concerns about anticompetitive conduct” with respect to prescription drug competition for biosimilars and biologics. Speaking for herself, Jex expressed concern that reimbursement systems, including rebate arrangements, are “chilling price competition” for such therapies.

The workshop will be held at the FTC’s Constitution Center Auditorium in Washington, DC, and is both free and open to the public.