FDA And CFDA Regulators Talk Up Innovation, Convergence
This article was originally published in PharmAsia News
Executive Summary
A former U.S. FDA commissioner and a senior director of China’s FDA shared views on the role of regulators at a recent conference held in Shanghai, stressing the need for a science-based approach, innovative approaches and international collaboration.
SHANGHAI – Emerging technology is bringing in a paradigm shift at the U.S. FDA, as the agency strives to ensure public confidence in its regulatory activities, former commissioner Margaret Hamburg told attendees at DIA’s seventh annual China conference, held in Shanghai May 24-27.
As the world becomes more connected than ever before, old paradigms need to give way to a new way of thinking and acting, she emphasized, “So the payer, physicians, patients, the public and the industry and regulators evolve in a coordinated way.”
Recalling her six-year tenure with the top food and drug regulator, an agency she led to record-setting years of new drug approvals, Hamburg said that “the U.S. FDA can and must be a gateway to innovation.”
To that end, FDA regulators must proactively seek ways to improve, reducing product recalls and litigation, and opening up markets around the world for domestic firms.
There lays a huge opportunity to turn ideas into actual procedures, stated Hamburg, who also visited China in 2010 after she took over the FDA leadership. In a speech delivered to Peking University students last November, she repeatedly emphasized bilateral cooperation (Also see "FDA Head: U.S. Has ‘Deep Relationship’ With China" - Scrip, 20 Nov, 2014.).
To enable patient access to new treatments in a timely way, regulators at the U.S. FDA are now focused on three themes, she pointed out.
The first is integrity and a firm footing in regulatory science, which is fundamental. The regulator needs to take “clear and science-based actions”, ensuring they are “transparent and trustworthy”. Meanwhile, there should be an emphasis on effectiveness and extending reach via listening sessions with stakeholders.
Transparency is key to becoming trustworthy, she stressed. Thus, it’s important to “overcome a black box image, where decisions are made behind closed doors and the public eyes” and to “explain what to do and gain trust.”
Regulators also need to step outside the system as the challenges become more global. Despite a golden age for the biopharmaceutical technology, underscored by new therapies for obesity and Alzheimer’s disease, there is still “a lot to be done,” she cautioned.
Innovation Challenges
One of the challenges is emerging health issues that occur across nations, such as the Ebola crisis, which call for more effective international coordination. FDA regulators are changing their thinking and actions on how and where studies are done, and the quality and robustness of data.
Meanwhile, regulators globally need to play a critical role in fostering an innovative ecosystem, incorporating adaptive trials, real world data, and bringing in patient perspectives, Hamburg proposed.
One particular challenge is the ethical controversy over the “editing” of human embryos, a technology called CRISPR. A recent paper by Chinese scientists detailed the first-ever attempt to do this, Hamburg noted, and has dominated headlines in the U.S. How to assess such research will be an issue for regulators to ponder, she said.
The final major challenge is a need for high-level coordination between regulators, the former U.S. chief health regulator said. Since products marketed in the U.S. are no longer available only in this market, ensuring safety in a global community requires seamless compliance.
She cited the International Conference on Harmonization (ICH) initiative as an example, and also said the FDA had conducted workshops on risk-based GMP inspections in China, which more than 1,000 China FDA inspectors have attended so far.
“Partnership is essential to do the job, and promote and protect health for all citizens,” Hamburg declared.
Last November, international regulators also met in Beijing to discuss ways to accelerate patient access to new drugs, and the CFDA has emphasized integration with respect to national regulations (Also see "Regulators Meet In Beijing To Balance Local With Global" - Scrip, 25 Nov, 2014.).
CFDA Touts Progress
A science-based regulatory approach is also the focus of the CFDA, noted Li Maozhong, deputy director of the agency’s Bureau of Registration Management, speaking at the same DIA forum.
“Innovation relies on a foundation and it also relies on science. Years of regulatory work make me realize how important science is,” Li told a large auditorium packed to capacity.
“If we can’t catch up with scientific developments, our series of regulatory policies will deter our progress,” he added, stressing that “[policies] including our administrative and regulatory decisions must catch up with scientific developments.
“In our management, there exist some practices that are lagging industrial development and R&D progress, so we must reform.”
To that end, the agency is preparing a comprehensive reform plan to accelerate new drug reviews and approvals, with a goal of improving efficiency and quality. Such measures include increasing reviewer headcount and new funding to accelerate reviews and enhance quality control, noted Yuan Lin, the CFDA’s director of International Affairs at the same forum.
The reform plan could come along with the revision of China’s Drug Administration Law, and Yuan said one of the revisions is to enhance the protection of clinical study subjects with a compensation system.
Meanwhile, an updated 2015 China Pharmacopeia has largely increased the number of products, he pointed out.
Increasing enforcement and penalties is another key aspect of CFDA’s regulatory thinking. The agency is working with other law enforcement agencies and giving real power to local branches, and is emphasizing responsibility and accountability, with heightened scrutiny via unannounced inspections and process-based monitoring.
Finally, in the area of risk management, the CFDA said it would enhance adverse effect reporting and monitoring via a dedicated inspector force, and also aims to increase post-marketing surveillance.
The regulator will levy penalties and increase pressure in these areas, Li stressed.