Rep. Diana DeGette (D-Colo.) was defeated in the Democratic primary Tuesday, ending the legislative career of a politician who built bipartisan support for the most impactful FDA reforms of the last two decades.
DeGette was the central figure in an informal alliance of patient advocacy groups, life sciences innovators, and government officials that pushed legislation across the finish line, creating FDA reforms that have been emulated around the world.
She is ranking member of the Energy and Commerce health subcommittee, and was slated to become its chair if Democrats gain a majority in the House.
DeGette’s loss came as she was building support for follow-on legislation, 21st Century Cures 2.0, that aimed to speed drug development through a new round of regulatory reform.
“We have lost a great friend,” Ellen Sigal, chairperson and founder of Friends of Cancer Research, told BioCentury.
DeGette “took the time to understand the science, she listened to patients, and she delivered results that were profoundly important,” Sigal said. She pointed to the 21st Century Cures Act, breakthrough therapy designation, expanded access to embryonic stem cells for research, and other legislative accomplishments.
DeGette’s absence from Congress is a “devastating loss for patients, for the health community, for science,” Sigal said. She added that DeGette was one of the few remaining exemplars of a style of governance centered on building bipartisan consensus among patients, FDA, NIH, and industry.
“Who,” Sigal asked, “is going to fight for the patient, who can deliver not just words, but deeds?”
What does the shift left mean for patients, innovators?
DeGette, first elected to represent Colorado’s 1st Congressional District in 1996, was defeated by Melat Kiros, a 29-year-old attorney and PhD student. Colorado’s 1st District hasn’t sent a Republican to Congress since 1970, so Kiros is very likely to win in November.
Kiros ran on a democratic socialist platform, portraying DeGette as a Washington insider beholden to corporate interests. She framed DeGette’s acceptance of campaign contributions, including from the pharmaceutical industry, as evidence that she was too closely tied to the drug industry and dependent on its donations.
Kiros said on the campaign trail that DeGette’s ties to industry are part of a larger pattern that has prevented the enactment of DSA priorities including creating a government-run single-payer healthcare system.
Kiros is part of a cohort of candidates affiliated with the Democratic Socialists of America (DSA) that will form a voting bloc in the next Congress.
The DSA and mainstream Democrats diverge on the life sciences at two levels.
On economics, DeGette and like-minded Democrats have treated pharma as an industry to be regulated and bargained with. The DSA platform calls for public ownership and manufacturing of drugs, while its candidates have also advocated sharp limits on profits and curbs on intellectual property.
On regulation, DeGette led a bipartisan push to promote innovation and speed therapies to patients. She and her allies repeatedly invoked the chasm between scientific possibility and medical reality, and acknowledged the need to modernize regulation and provide financial incentives for businesses to fill the gaps. The socialists with whom Kiros aligns emphasize the fight against industry capture of regulatory agencies and distrust any loosening of traditional evidentiary standards.
From stem cells to 21st Century Cures
DeGette’s alliances with patients and scientists dated to the early 2000s, when she pushed back against restrictions on stem cell research. She wrote the Stem Cell Research Enhancement Act, legislation Congress passed in 2006 and 2007 that reversed President George W. Bush’s restrictions on embryonic stem cell research. Bush vetoed the legislation twice; President Barack Obama incorporated it into an executive order.
In 2014, she teamed up with Rep. Fred Upton (R-Mich.) to develop legislation that became the 21st Century Cures Act.
The sprawling legislation, which was enacted in 2016, aimed to modernize the evidence base for drug approvals, give patients a voice in regulatory decisions, and reform FDA’s structure and funding.
21st Century Cures paved the way for faster drug development and more flexible regulation, especially for rare diseases, cancer, and gene therapies. Mechanisms that were contested before the law passed, including real-world evidence for supplemental indications, external control arms, surrogate and interim endpoints outside oncology and infectious disease, are now routine.
The law created the regenerative medicine advanced therapy (RMAT) designation and gave FDA authority to offer salaries that are competitive with the private sector.
The challenge for advocates who want to expand these and other provisions in the 21st Century Cures Act is to build a new bipartisan coalition. They’ll need to win over politicians like Kiros and get them to find common ground with Republicans at a time when DeGette’s style of consensus-building looks like a relic of a different era.
https://www.biocentury.com/article/660006/degette-s-primary-loss-a-blow-to-fda-reforms