The pharmaceutical industry will need 10 years to become fully compliant with FDA's March 1997 electronic records and signature final rule, PhRMA told FDA in a position paper.

"A period of 10 years may be necessary to implement the required changes in all affected systems," the Pharmaceutical Research & Manufacturers of America said. The 1997 rule defined criteria, including system controls and security requirements, under which FDA would consider electronic records and signatures equivalent to traditional handwritten signatures.

"Since one of the goals of electronic signatures is to ensure that they are non-repudiatable and legally enforceable, which adds an additional level of complexity, questions around the issuing and validation of keys, and whether this can be done by individual companies or will require trusted third parties, still need to be resolved," PhRMA said.

"Ultimately, the validity of these new approaches needs to be tested in litigation and it is likely to be 3-5 years before [electronic signature software programs] are widely used in major business systems," PhRMA noted, defending an extended compliance timeframe.

"In spite of sincere efforts to implement" FDA's electronic records and signatures rule, "PhRMA members have found it to be a major burden that is extremely difficult, if not impossible, to fully comply with," the trade association reported to FDA.

PhRMA noted that some implementation delays stem from industry's need for vendor software companies to develop compliant software packages. "The industry has a strong preference for the unmodified use of commercial products from market leaders."

"Even where vendors see a commercial advantage in being able to offer compliant software, the time taken to generate new releases is normally 12-24 months," PhRMA said. Industry generally then only implements the second generation of the new software "so the initial round of problems have been detected and resolved." Finally, installation of a software package typically takes 6-12 months, PhRMA said.

FDA's rule "defines a desired future state but is not based on current best practices within the industry or the capabilities of the current generation of major software products that are in place," PhRMA said.

As a remedy, PhRMA proposed a "partnership approach aimed at meeting the requirements of the FDA in a manner compatible with the capabilities of available technology" under which current best practice procedures could suffice as an appropriate starting point for compliance.

Bringing existing "legacy" systems into compliance and long-term archiving of electronic data were cited as particular concerns of PhRMA, given "the rapid obsolescence of technology."

PhRMA prepared its position paper - also submitted to FDA Associate Commissioner for Regulatory Affairs Dennis Baker - after the agency told the association that it considered the costs of the final rule to be outweighed by the savings from use of electronic records (¹ Also see "Electronic Signature Rule Costs Offset By Efficiencies, FDA Tells PhRMA" - Pink Sheet, 6 April, 1998.).

In separate comments submitted Nov. 30 in response to a Federal Register notice on the rule's paperwork burden, Baxter Healthcare noted the requirement that companies provide FDA with copies of their software slows compliance and introduces a "legal burden" to industry. "Most major systems employ propriety software packages that include licensing requirements regarding number of users and installations," Baxter said. "The requirement that industry provide copies places industry in the position of violating or renegotiating licensure agreements to comply."

SmithKline Beecham told FDA that a "more realistic timeline" for full compliance was needed to allow firms not only to bring their internal systems into compliance, but also the computer systems of third party vendors such as contract research organizations.

SB acknowledged that FDA "has exercised its discretion in permitting companies both to prioritize their systems, and to achieve compliance in a step-wise" fashion. "While we applaud FDA's cooperation to date, industry has no formal assurances FDA will continue to exercise discretion in this manner." The final rule became effective in 1997.

SB's estimated cost for its internal compliance initiatives exceeds $214 mil. between 1999-2001. Lilly expects its overall cost for compliance to exceed the cost of the firm's Y2K initiative, with a price tag "as much as $150 mil. as an initial expense...and an ongoing maintenance cost of around $30 mil."

Electronic Record/Signature Rule Requires 10 Years For Compliance - PhRMA

More from Archive

More from Pink Sheet