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Califf’s Return as FDA Head Will Give Drug Competition a Boost

Nov. 12, 2021, 9:29 PM

Improving drug competition and boosting patient access to innovative treatments will likely be among the priorities of Robert Califf at the helm of the Food and Drug Administration, policy analysts say.

President Joe Biden on Friday nominated Califf, a cardiologist and widely published researcher, to replace acting FDA Commissioner Janet Woodcock. If confirmed by the Senate, Califf is poised to bring steady leadership and clear direction on how to improve the FDA’s efficiency as the federal government continues to respond to the ever-changing Covid-19 situation.

“He has a very calm demeanor, which is important for running such a significant federal agency, especially during these challenging times,” Chad Landmon, a partner at Axinn Veltrop & Harkrider LLP, said. Califf will bring a “steady hand to the Commissioner’s office,” given his recognition among FDA personnel and the pharmaceutical industry, Landmon added.

Analysts and former FDA officials, including those who worked closely with Califf when he led the agency in the final year of the Obama administration, say that Califf will prioritize issues central to Biden’s agenda, including bringing more generics and biosimilars to the market to help drive down costs. They also say Califf will focus on removing barriers across the pharmaceutical supply chain and increasing access to new lifesaving treatments like cell and gene therapies—two issues he sought to address during his previous tenure.

Biden said in a statement Friday that Califf’s “experience and expertise” make him uniquely qualified to lead the FDA. White House press secretary Jen Psaki told reporters that Biden sees Califf as a “continuation of what he views as excellent work under the leadership of” Woodcock, who was ruled out as the permanent FDA leader this year due to opposition on Capitol Hill.

Califf said in a statement that there is a “lot of work to do” as he hopes to help the agency in its “inspiring mission to serve the public.”

Califf’s first appointment to lead the FDA was approved in an 89-4 vote in 2016. Biden’s nomination of Califf, however, has spurred some opposition from moderate Democratic lawmakers like Sen. Joe Manchin (D-W.Va.), who cited Califf’s past work as a consultant to drug companies and the impact of the opioid epidemic as justification for picking an alternative nominee.

Psaki said Friday that the White House was confident Califf would be confirmed despite Manchin’s opposition.

Drug Competition

Califf has signaled that tackling rising drug costs could be a priority for him as the next FDA commissioner. He co-authored an editorial piece in 2019 that advocates for “a sustainable, fair payment system in which drug prices reflect the value provided and reward innovations that improve outcomes.”

While the FDA doesn’t play a dominant role in setting drug prices, analysts say that approving more generics and biosimilar products would eventually lower costs by providing consumers with cheaper alternatives to brand-name drugs.

“Streamlining the time it takes for drugs to reach the market, be developed and reach the market, would of course reduce costs,” Howard Sklamberg, who previously served as deputy commissioner under Califf, said.

Landmon said the FDA could play an important role by “just deciding those things quicker and realizing when” brand-name drug approval applications “are just being filed to delay competition.”

The increased attention to the FDA’s role in drug pricing marks a change from previous years, Stacy Cline Amin, former chief counsel for the FDA who also served as chief counsel to the Senate Health, Education, Labor, and Pensions Committee during Califf’s confirmation hearings, said.

“One of the things that has been interesting in this administration is seeing FDA wade into discussions that it has traditionally tried very hard to not be involved in, like patent law discussions,” Amin, a partner at Morrison & Foerster LLP, said. She added the FDA has typically avoided discussions on drugmaker patent practices, such as filing patents for the sole purpose of weeding out competitors.

The Association for Accessible Medicines, a trade group representing manufacturers of generic and biosimilar drugs, said Friday that “its member companies stand ready to work with Dr. Califf and the entire FDA team to ensure America’s patients have timely access to safe, effective and quality generic and biosimilar medicines.”

Supply Chain

Shortages along drug supply chains and promoting common inspection standards across the globe were both areas of interest to Califf during his first run at FDA commissioner, and are likely to come into focus if he is confirmed once again, analysts say.

Califf in 2016 was “very struck by the increasing volume of imports of products into the U.S., both finished products and components of products,” Sklamberg, who now works as an FDA regulatory and policy attorney at Arnold & Porter, said. “He would be a big supporter of additional FDA resources to oversee imports.”

He would support the expansion of mutual recognition agreements, Sklamberg said, under which the FDA can recognize drug inspections conducted by other countries deemed to be in line with U.S. standards. The FDA currently has several such agreements with regulatory bodies in the U.K. and across the European Union.

Califf would also be tasked with addressing drug shortage reporting standards implemented through the Coronavirus Aid, Relief, and Economic Security, or CARES, Act. Manufacturers have recently raised logistical questions on how to comply with the updated reporting requirements as deadlines loom.

Patient Access

Boosting investments in new innovative treatments has also been among Califf’s longtime interests, former FDA officials say.

Califf, who is currently the head of clinical strategy and policy at Alphabet Inc.’s Verily and Google Health units, could use his experiences from the private sector to improve the use of personalized medicine and digital health technologies, Sklamberg said.

Integrating real-world evidence into drug research is also a priority for Califf, according former FDA Deputy Chief of Staff Kalah Auchincloss.

“He’s a thought leader, and he’s really good at that,” she said. “Real world evidence was a big, big priority of his last time, so he is definitely a thought leader and wants to be involved in kind of the day-to-day, hands-on science and kind of learning at the agency.”

During Califf’s previous tenure, the FDA established an expedited pathway for bringing regenerative medicine advanced therapies to the market. Such therapies include “a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products,” that can treat, modify or cure a life-threatening disease, according to the FDA.

Califf’s nomination comes “at a momentous time for public health and the development of innovative technologies,” the Alliance for Regenerative Medicine said in a statement.

“Pending Senate confirmation, ARM looks forward to continuing our work with Dr. Califf and the Center for Biologics Evaluation and Research to deliver life-changing therapies that address the root causes of devastating diseases.”

—With assistance from Ian Lopez

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com

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