Regulatory Collaboration Is Key to Public Health Success

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Federal health agencies should work together to address public health problems.

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Federal policymakers have recently made a push to address excessive drug price increases and slow medicine development as part of their health care agenda.

But the latest health care legislation introduced in Congress and the federal government’s larger policy plan are unlikely to drive the innovations necessary to improve the health of the American people, argues Rachel Sachs, a professor at Washington University School of Law.

The government’s new policies fail to encourage regulatory collaboration and data sharing among federal health agencies, which will prevent health care innovators from designing effective and sophisticated health care solutions, says Sachs. Instead, the government’s new policies improperly focus on using the resources of individual federal health agencies.

To support the claim that the government’s policies have failed to meet the health needs of Americans, Sachs points to the lack of innovation in mental health care, which persists in spite of an ongoing mental health crisis in the United States.

According to Sachs, too many regulations aimed at the development of treatments for mental disorders seek to leverage the resources and capabilities of the U.S. Food and Drug Administration (FDA)—the federal agency that regulates the pharmaceutical industry. Although Sachs recognizes that pharmaceuticals are a “fruitful avenue” for mental health treatments, data sharing between the National Institutes of Health (NIH) and the Centers for Medicare and Medicaid Services (CMS) would enhance mental health innovations beyond the pharmaceutical industry, she says.

The NIH plays an important role in the development of medical treatments and, according to Sachs, the agency would benefit from the tremendous amount of data possessed by CMS. CMS retains data on the insured population of over 100 million Americans, which include data on the diseases most “underserved by medical technologies,” writes Sachs.

With these data, the NIH could design research projects geared toward the development of treatment technologies tailored to the mental health needs of the American people, such as cutting-edge psychotherapeutic and exercise-promoting interventions.

Moreover, data sharing between the NIH and CMS would allow mental health care consumers to enjoy better health insurance rates. Because the NIH possesses a lot of data on the cost-effectiveness of available mental health treatments, CMS could charge insurances rates that correspond more accurately with the quality of mental health treatment, instead of overcharging for ineffective treatment options, says Sachs.

In addition to collaboration between the NIH and CMS, government regulations would also foster collaboration between the NIH and FDA, argues Sachs.

The projects on which the NIH and FDA currently work together, such as the Tobacco Regulatory Science Program, the Interagency Pain Research Coordinating Committee, and the BRAIN Initiative, are creations of external government institutions. Congress, for example, designed the Interagency Pain Research Coordinating Committee, and it tasked the NIH and FDA to oversee its operations.

To foster “valuable data-driven, purposive collaborations for innovation in health technologies,” Sachs recommends that the NIH and FDA complement these externally created initiatives with a collaborative strategy aimed at aimed at other pressing public health problems, such as the ways in which FDA regulates how drug innovators bring their products to market.

Indeed, FDA’s regulatory processes are problematic, states Sachs. Drug approval is lengthy, and agency inefficiencies weed out potentially valuable pharmaceutical technologies. With its large research capacity, the NIH can generate cutting-edge studies in the area of regulatory science to help FDA speed its drug approval process by making it more efficient and accurate, while increasing FDA’s ability to block defective or otherwise non-compliant drugs from reaching the market.

Moreover, Sachs proposes that the NIH and FDA increase transparency and public accountability on their collaborations, in hopes of improving the communication between federal health agencies and health innovators.

The NIH and FDA leaders currently release neither public records nor reports about their projects, notes Sachs. If the NIH and FDA are to respond successfully to the health needs of Americans, Sachs advocates for transparency about agency goals and methodologies, thereby inviting the public to have an important role in the health innovation discussion. Information about disease prioritization, for example, would help inform the American public about where the government focuses its innovation resources, and it would highlight where gaps in health policy-making exist.

Transparency would also help researchers and companies design technologies that align with the priorities of government agencies. With greater knowledge about the direction favored by the NIH and FDA, health technologists would discover more quickly where to invest resources and what health burdens to target.

Although Sachs recognizes that barriers may inhibit these avenues for collaboration—such as laws that constrain agency jurisdiction, privacy-related restrictions, and increasingly scarce agency resources—the federal government has the tools to break down these barriers, she argues. And without concerted collaboration between federal health agencies, opportunities for health innovations to address major public health problems decrease by the day, emphasizes Sachs.

Sachs’s paper appeared in the Cardozo Law Review.