n October 1964, a group of pharmaceutical and medical communication and information professionals gathered in Philadelphia (PA) for conversations which culminated in the formation and inaugural meeting of the Drug Information Association (DIA) in Washington, DC, on October 9, 1965.

What followed was six decades of vibrant global dialogue and action to benefit public health.

Why DIA?

Drug information challenges from the respective professional perspectives of DIA’s founders helped shape their vision for this new organization. Many of the ideas expressed in these 1966 articles remain valid six decades later. To many observers, the sheer amount of generated and accumulated information on drugs (including information produced by the drugs’ clinical development) seemed overwhelming even then. Today, information on drugs and clinical research is growing so rapidly in complexity and volume that it is still challenging to process it accurately and completely. Different terminologies, methodologies, and purposes continue to build barriers between the different functions responsible for this work. Add the rapid evolution of new devices and their increasing importance in improving patient health outcomes to this mix, and the information overflow is complete. Has this situation changed for the better since 1964? For starters, the “D” in “DIA” now no longer stands for “Drugs” alone but now encompasses the expanding and evolving domain of devices and diagnostics.

DIA’s founders established an organization that was and remains objective, neutral, educational, and cooperative. Regulators and drug developers come together and share challenges and solutions as DIA authors, program speakers, committee members, and Association leaders. This neutrality still stands as a pillar of DIA to this day.

“Its mission in the drug information field is to help find solutions for knotty problems, to act as a sounding board for new ideas, and above all to promote harmonious and productive interactions among all who work with drug data,” Martin said. Since then, this original idea has been translated to action as DIA’s focus has gradually expanded from drug data to the entire continuum of drug development, registration, and patient access, to global engagement and impact.

The 1966 publication focused on what has become DIA’s foundational pillars: Safety, standardization, automation and technology, and collaboration and cooperation. Readers may recognize elements of these same challenges at work today as well as examples of work accomplished by DIA’s worldwide volunteer community over the past six decades to address those challenges.

Safety

Back in 1965, Martin noted that issues with reporting adverse drug reactions to a popular sedative (thalidomide) given to combat nausea in pregnant women contributed to birth defects in thousands of babies born in Europe. In response to this tragedy, in October 1962 the US Congress had passed the Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetic Act, to require manufacturers to demonstrate the safety and efficacy of drugs before they could receive marketing approval. This was a sea change in the drug development ecosystem that existed at the time.

Quick and accurate reporting and information about drugs and patient reactions to them was essential to keep the healthcare ecosystem healthy, Martin argued. “Efforts are constantly being made by the medical profession, government, and industry to place drug reaction reporting in proper perspective and to make it sufficiently complete to be useful,” he said.

As we enter a new, transformative era of cell, gene, and other advanced therapies, working to ensure patient safety against a rising tide of misused or counterfeit drugs remains critically important. The need for clinicians, industry, regulators, and associated organizations to share information about drugs and adverse reactions more completely and systematically remains essential to protecting and preserving patient safety today.

Standardization

In the 1960s, lack of standardized terms and processes presented challenges to sharing current, accurate, and complete drug information.
Standardizing the terminology that expresses drug information, and standardizing the tools and technologies which disseminate that information, was a foundational educational objective for DIA.

The vision for this objective included standardizing case report forms for different drug categories so that, for example, certain routine information appears in the same place with standardized precoding (where possible), and standardizing headings and information categories for New Drug Applications (NDAs) for each major type of medication. This vision saw standardizing terminology as a linchpin in the process of selecting, collecting, evaluating, writing, and publishing drug information.

“Use of a common language will facilitate the development of compatible systems for the rapid and total exchange of drug information, both nationally and internationally, by telephone, television, phototelegraphy, or other rapid electronic means,” explained Martin.

Automation and Technology

“Other rapid electronic means” foreshadowed the growth of automation and computer and digital technology in collecting, processing (i.e., selecting, abstracting, indexing, and coding), and communicating drug information. As modern data processing and computer technologies began to emerge, many founders recognized the need for professionals to gain experience with them and foresaw DIA as a platform for mutual education and training. They also believed that the NDA process would be more efficient if data were standardized and computerized to streamline the processing and evaluation of data by both industry and the regulators.

Electronic data capture and cloud technology were almost unimaginable in 1965; in 2024, we cannot imagine drug development and communicating information without them.
The founders’ early focus on the NDA and its contents, informed by the regulatory requirements of the day, foretold the rewrites (revisions and updates) of the regulatory requirements for the NDA and Investigational New Drug (IND) application in the mid-1980s. In 2024, we stand on the brink of collecting, compiling, submitting, and reviewing these applications as dynamic dossiers in the cloud.

Their emphasis on automation also foreshadowed the current rise and evolution of artificial intelligence to power processes and applications throughout the drug development and risk communication and management lifecycle.

In his keynote address, “A Physician Looks at Drug Information,” Chester S. Keefer (Boston University) reiterated the growing importance of technology in drug information and training to develop expertise in its use. “Your officers, your directors, and your founders deserve applause for their foresight and for the recognition of a need to further modern technology of communication in medical, pharmaceutical, and allied fields,” Keefer said. “As you develop new tools and methodology and exchange information, improvements in methods of communication to all interested parties will follow.” They certainly did.

Collaboration and Cooperation

Collaboration, cooperation, and communication between all relevant stakeholders were critical cornerstones of DIA at its very outset. “The fundamental idea is simply this: A climate of cooperation expedites the transfer of drug information from the minds of those who have it to the minds of those who need it, with a minimum of duplication of effort,” Martin explained.

Cooperative, reciprocal interchange of ideas and instruction would advance reporting of adverse drug reactions by illuminating the connections, for example, between clinicians conducting clinical studies and computer programmers working to automate handling of the clinical data they generate. Collaboration and cooperation can bridge interdisciplinary, departmental silos in every type of organization, and—as drug development and clinical research grow more global—in every nation and regulatory jurisdiction.

For more than three decades, DIA has strongly supported and advanced the work of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). In 2008, for example, DIA convened the first conference to systematically introduce ICH methodologies to the Singapore region. In 2018, China became an official member of ICH, with facilitative support from DIA.

Generational Considerations on Equity

The founders of DIA were indeed mostly “fathers.” Precious few women appear in photos from this inaugural event. This is not to be critical of the past but to acknowledge progress and the continuing journey toward equity for all.

The world has changed since DIA’s inaugural meeting 60 years ago. DIA’s evolution reflects progress in ensuring equal opportunity and access for people of every gender, ethnic, socioeconomic, and other orientation, a journey in which DIA has participated fully and enthusiastically.

We have come a long way regarding the role of women in the evolution of DIA, drug development, regulation, Board membership, and DIA membership at large. DIA global staff is currently 78% female and 22% male, for example, and females have constituted more than 40% of the DIA Board of Directors and fully one-half (50%) of the Board Chair/President positions during the past decade (2013 through the end of 2023).

“Devotion to the Ideal of Improvement”

“Improving relations and communications in the field of drugs will require team play for success,” Keefer noted. “And this in turn means mutual sympathy, understanding, and devotion to the ideal of improvement.”

This devotion to the ideal of improvement is alive and well to this day, and for at least the next 60 years.