Deputy Director Talks About Implementing Biosimilar Policy Within the FDA

With a variety of policy ideas circulating around Washington, DC, in regards to stimulating biosimilar competition and lowering drug prices, the role of the FDA is to provide technical assistance to those legislative staffers and others looking for information, a key FDA official told a packed audience at the ACI 10th Summit on Biosimilars on Monday in New York City.

Joseph Franklin, JD, PhD, deputy director under the FDA’s principal deputy, Amy Abernathy, MD, oversees biosimilar policy work, including the various guidances that have been released the past year. He recapped what the FDA has done and what is expected in the future.

When former commissioner Scott Gottlieb, MD, was still in charge of the FDA early last year, he said they began to “drill down and see how we could produce the momentum behind the program, the momentum behind the product development and approval for many industry stakeholders, and the concerns about drug pricing generally to focus FDA’s program on key areas.”

Out of that came the Biosimilar Action Plan, followed by other communications, including 6 released in December 2018 alone. Franklin highlighted several others, including the interchangeability guidance, one on comparative analytical assessment in order to support biosimilarity, and one on naming conventions.

“These efforts reflect the commitment of the FDA to [collect user fees] and use those for policy development,” he said. In addition, they allow him to build up full-time staff dedicated to biosimilars.

Looking ahead, the FDA anticipates releasing 3 other proposals, but Franklin would not give a time frame. One is the so-called “carve out” guidance, to give clarity to biosimilar applicants who seek approval for fewer than all of the indications for which a reference product is used. The others are draft guidances on product presentations for interchangeable products and an enhanced version of the Purple Book.

Biologic regulations are complementary to FDA’s drug regulations, which are also provided for in the Hatch Waxman law, Franklin said. “Regulatory efficiency and regulatory transparency go hand in hand,” he said.

As difficult and time-consuming as it is to update guidance documents, Franklin said there is an awareness within the FDA that applicants are evaluating and resolving intellectual property issues in parallel with their interactions with the agency.

“It strikes me that you’re really working hard to figure out how to make this whole system work more efficiently, make it work better for patients and payers,” said Donald R. Ware, JD, a partner Foley Hoag LLP, who moderated a question-and-answer session with Franklin.

Ware asked about the process that goes on within the FDA to weigh in on different proposals. “Drug pricing bills are changing so rapidly it can be hard to track them,” he said, noting they range from looking at patent issues to seeking changes within the FDA itself.

“Does the FDA comment? Or does it just sit back and watch?” Ware asked.

Franklin said there is a “well-established process to provide technical assistance,” usually in the form of predicted outcomes and results that might occur from a given change. But policy opinions are left out, he said.

“The official views of the administration are described in documents you can download from the White House. We don’t comment on merits and objectives,” he said.

Ware also asked about the role of Federal Trade Commission (FTC), noting that a bill put forth by Senator John Cornyn, R-Texas, would have the FTC play a bigger role in cutting through patent thickets. Questioning the level of expertise the FTC has to make decisions about therapeutics, Ware asked about coordination between the 2 departments.

“We have great working relationships,” said Franklin. The FDA gives guidance to other agencies and is always looking to communicate with stakeholders, he said, but he wouldn’t comment on his opinion of the bill.

Overall, the FDA sees its role in any possible patent resolutions as “ministerial and limited,” he said.

Ware also brought up biosimilar insulins, which will transition in March 2020 from regulation as drugs under the Food Drug and Cosmetic Act to biologics under the Public Health Service Act.

“It’s also interesting when you think about it [in terms of] interchangeability,” Ware said. “Can you comment on future of insulin?”

“The future of insulin is hopefully full of lower prices for patients,” said Franklin.

“The imperative is to find a way to make sure that biosimilar interchangeable products can get on the market to compete as much as possible.”