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Laura Smith

FDA Compliance

New Biopharmaceutical Coalition Aims to Support SAFE Initiative

Implementation of new standard could save companies millions.

Published: Tuesday, March 22, 2005 - 22:00

In hopes of cutting administrative costs and streamlining the amount of time it takes to get new drugs to consumers, eight global pharmaceutical manufacturers have formed a coalition, SAFE-BioPharma, to support the widespread adoption of the new global digital identity standard, Secure Access for Everyone (SAFE).As the biopharmaceutical industry has become more automated, it’s also become more collaborative. Inter-agency relations are more important than ever, but automation makes maintaining such relationships a challenge. This situation creates the need for a standardized communications approach to e-signatures that is both secure and legally enforceable.

SAFE was introduced in June 2004 and includes policies, procedures, guidelines, technical specifications and a liability risk management framework for ensuring the validity and identity of authorized users. The network on which it operates was designed to assure member companies complete security while reducing the risks and costs associated with creating internal, legally enforceable digital signatures.

The increased use of SAFE should come as welcome news to the industry, as drug regulatory agencies around the world, including the U.S. Food and Drug Administration and the European Medicines Agency, have long supported the theoretical use of such a system. The sticking point has always been the lack of universally accepted standards, says Gary Secrest, the director of worldwide information security at Johnson & Johnson and chairman of the SAFE initiative. The new coalition’s example and encouragement should help the widespread adoption of the standard.

“Over the past year, the SAFE coalition sponsors have provided the resources and leadership to develop the standard needed to solve a common business problem,” Secrest says. “With the establishment of SAFE-BioPharma LLC, the industry can begin commercial implementations and use of the standard.”

The founding members of SAFE-BioPharma are AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck & Co. Inc., Pfizer, Proctor & Gamble and Sanofi-Aventis. The nonprofit agency will manage and maintain the SAFE standard, provide accreditation and certification programs for users, establish best practices to simplify SAFE implementation and operate the SAFE Trust Bridge, which is an interoperable infrastructure to certify divergent public key infrastructures (PKIs) to the standard.

The SAFE standard has been in development for more than two years. Before completion, it was reviewed by the FDA, the European Agency for the Evaluation of Medicinal Products (EMEA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA).

In addition to reducing time-to-market for new drugs, another important purpose of the standard is to help save pharmaceutical companies money. For example, SAFE-BioPharma LLC estimates that clinical research investigators have as many as seven to 10 independent credentials for security protocols and e-signature requirements by as many companies. The cost of this system redundancy is estimated to be $200–300 million annually, according to SAFE-BioPharma LLC. In addition, the current multicredential approach creates confusion, higher training costs and higher turnover rates. SAFE addresses this need by providing a legally enforceable method of simultaneously ensuring compliance and user identification, says Guy Tallent, SAFE initiative program director.

According to Tallent, there are approximately 700,000 potential SAFE users in the biopharmaceutical industry, and SAFE could save companies upward of $100 per user annually. Thus far, there are only 200 users worldwide, but Tallent notes that the program is still young and says he expects that number to rise quickly.

“In terms of dollars and cents, it’s a major cost-saver for companies,” Tallent says. “And in terms of ease and efficiency, it’s also extremely beneficial.”

The approach the pharmaceutical industry is taking is similar to that of the banking industry, which created Identrus LLC, an electronic authentication system, five years ago. The system provides a set of identity, authentication and security standards that allow safe electronic transactions between banks and financial institutions, streamlining cooperation while providing the necessary security.

Pamela Fusco, chief information security officer Merck & Co. Inc., reports that SAFE’s implementation at her company has made communication significantly easier. Merck started using SAFE in September 2004. Since then, the company has a much better understanding of the platforms that its vendors and partners have, Fusco says. She adds that SAFE hasn’t become a point of competition between companies—just the opposite is true.

“It’s been great, because it allows us to figure out what system is the best fit for everyone,” says Fusco. “When we can share important information, it benefits everyone involved.”

While it’s still too early to tell exactly how many SAFE users there are or how much money companies will save by using the SAFE system, Fusco says several internal Merck departments are interested in becoming registered users.

“Now that word is getting out, folks are beating down the door to use it,” she says. “I think interest is really peaked right now and people are very interested in learning how SAFE can benefit them and their companies.”

More information about SAFE-BioPharma is available online. To learn more, visit www.safe-biopharma.org.


About The Author

Laura Smith’s picture

Laura Smith

Laura Smith is the manager of global training certification at Exemplar Global, a worldwide certification body and provider of competency-based personnel certifications.