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By Mark D. Uehling

May 15, 2004 | The U.S. Food and Drug Administration (FDA) is about to open the floodgates. It quietly offered a forum for the industry to comment on how the agency should revisit 21 CFR Part 11, the keystone electronic signature/electronic submission regulation for the life sciences.

"FDA would like public input to assist with our re-examination of Part 11,"  the agency said in April, announcing a June 11 hearing in Washington, D.C. "We invite discussion on the scope of Part 11, risk-based approaches, validation, audit trails, record retention, record copying, and legacy systems."

Ever since the FDA let it be known last summer that it was suspending enforcement of key portions of Part 11, the question hanging over drug companies and the vendors who support them has been what, if anything, might replace Part 11. "We said we're going to move on this, and we're moving," notes Joseph Famulare, director of the division of manufacturing and product quality, part of the office of compliance in the FDA's Center for Drug Evaluation and Research (CDER). "We expect a good amount of interest."

Famulare went on to say that much of Part 11 regulation remains in force: "If you don't have accurate records, trustworthy and reliable, you're very much at risk." Not everyone agrees.

With a radically lower or nonexistent threat of federal inspections, many companies that develop drugs are already trimming the budgets used to attaincompliance with Part 11. A group called the Coalition for 21 CFR Part 11 is working behind the scenes to weaken Part 11 further, for a variety of political and business reasons.

The Coalition is composed of representatives from 14 industries regulated by the FDA but lead by Pharmaceutical Research and. Manufacturers of America (PhMRA), the drug industry lobbying group. PhMRA hopes a second Bush administration could completely abolish Part 11. Led by Alan Goldhammer, PhMRA's Associate Vice President, Domestic Regulatory Affairs, the Coalition will be trying to maximize its share of the agenda at the June meeting and be working closely with Republican appointees at the FDA.

At the same time, other stakeholders who actually like some of Part 11 -  yes, Virginia, that species does exist - are concerned that a little too much loosening of the rules could undermine efforts to make sure that paper and electronic records are not tampered with. "Because there's less emphasis by FDA, there's less dollars and less emphasis from senior management. There's a concern they will lose the momentum they had going forward to correct deficiencies in these electronic record systems," says John McKenney, president and CEO of SEC Associates, a regulatory consulting firm.

McKenney continues: "Some of the parts of Part 11 were over the top. We need to back away from those. But a lot of it was fundamentally sound and we need to find a way to continue it." One of the key issues at the June meeting, he says, will be how specifically the FDA needs to delineate which records are covered under the regulation. Some so-called "predicate" rules referred to in Part 11 say specifically what information needs to be audited, managed and authenticated.

Other parts are more vague. An example: The records of an institutional review board (IRB) are a gray area. Another issue: The predicate rules never anticipated computers, much less some of the data-generating laboratory instruments and software packages now available for the life sciences.

Says McKenney: "If they're going to say, 'Let's just rely on the predicate rules,' you run into a problem when the predicate rules don't account for the differences between electronic records and paper-based records."

The FDA's relaxation of enforcement of selected portions of the regulation certainly does not mean, McKenney says, that biotech and pharmaceutical companies can breathe a sigh of relief and ignore Part 11. "None of the electronic signature guidances were touched," McKenney notes. "You may want to have those audit trails and other features the FDA isn't pressing for, for other business reasons. It's more important than ever to check for tougher requirements that may apply such as the International Conference on Harmonization (ICH) or legal requirements for evidence and protection of intellectual property. It's really important to take a look at that."

That's because the global regulatory landscape is considerably more complex in the absence of Part 11 as the most stringent rule governing electronic data. In some cases, HIPAA, financial regulations, even European law could be the governing statute in some research activities.


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