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Press Release: PPI Releases Policy Memo Revealing FDA Regulations Struggling to Keep Up With the Digital Age

WASHINGTON—The amount of regulation on the pharmaceutical industry has increased 40 percent since 2000, according to a policy memo released today by the Progressive Policy Institute (PPI). Moreover, some new draft regulations proposed by the Food and Drug Administration (FDA) this year fail to embrace data-driven innovation.

In FDA Regulation in the Data-Driven Economy, PPI Economist Diana Carew details new regulations proposed by the FDA designed for a slower, information-poor age. The memo concludes with policy recommendations for how the FDA can improve outcomes while still protecting consumers in a data-driven economy.

“In a data-driven economy, regulators should encourage greater information sharing, instead of pre-emptively regulating information in a way that controls and ultimately restricts it,” Carew writes. “Regulators should take the role of watchful guardians over data and information flows, taking action when there is evidence of harm or injury.”

“We hope that regulators within the FDA and across other regulatory agencies will be able to use this example as a guide for approaching future regulatory questions surrounding data. Embracing the data-driven economy is the best way to promote future prosperity and well-being for all Americans.”

The memo focuses on one draft FDA guidance in particular, issued in February 2014, entitled “Guidance 
for Industry: Distributing Scientific and
 Medical Publications on Unapproved New Uses— Recommended Practices,” which lays out a lengthy list of rules and restrictions for how drug and medical device manufacturers are allowed to communicate with healthcare professionals and “healthcare entities,” such as hospitals, on unapproved new uses. It discusses the draft guidance and explains why it is not adequate for the digital age. Finally, recommendations for the draft guidance are provided, and the memo concludes with an expansion of the discussion to how this case study can serve as an example for regulators struggling with rulemaking in this time of unprecedented economic transformation.

PPI has undertaken extensive research on regulation in the 21st century, aimed at guiding regulators and policymakers through this transition. Our work strives to strike the right balance between protecting consumers and encouraging innovation in an interconnected world.

Download FDA Regulation in the Data-Driven Economy