When FDA Tackled Tobacco Regulation, the Hardest Decision Involved Software
In the midst of the most ambitious regulatory undertaking in the Food and Drug Administration’s 90 years, FDA officials found themselves bitterly divided over one key question: Which word-processing program should the agency use to draft its precedent-setting regulation of tobacco?
The standoff was resolved only when FDA Commissioner David A. Kessler stepped into a computer bookstore during a trip to Los Angeles and asked the sales staff to recommend the best program for a big job.
The fact that the biggest internal dispute was about what software to choose reflects the remarkable degree of unanimity within the agency over the merits of overturning decades of tradition by classifying nicotine as an addictive drug.
“That was probably the hardest decision we had to make,” said one senior agency official, who asked not to be identified. “The rest was easy.”
Easy to resolve the issues, perhaps, but not so easy to write the regulations, which President Clinton issued Friday.
That process involved dozens of people working round the clock, hauling portable air conditioners into their offices so that they could work after hours when the central air conditioning was turned off, lugging documents home to study during a February blizzard when no one could get to work, reading and digesting more than 700,000 pieces of mail, scanning every word into a computer database and targeting every issue that needed resolution.
The agency drew upon specialists from congressional staffs and other government offices: among them Phil Barnett, who ran an investigation of tobacco for Rep. Henry A. Waxman (D-Los Angeles) when he was a subcommittee chairman, and Judy Wilkenfeld, who worked at the Federal Trade Commission for many years and is regarded as an expert on the regulation of advertising.
As deadlines approached, vacations were canceled. One staff member who had been studying law had to postpone her bar examination.
“It was a pretty overwhelming task,” said an FDA official who, like all officials interviewed for this story, asked not to be identified. “I think we received more comments on this proposal than any agency has ever gotten. Certainly it was more than we’ve ever gotten.”
The word-processing wars resulted from harsh lessons from the previous year, when the FDA switched from WordPerfect 5.1 to WordPerfect 6.1 as it was drafting its proposed tobacco regulations.
WordPerfect 6.1 “was pretty new to the agency, and we had horrendous problems,” recalled an FDA staff member. “The documents were so big that the computers kept crashing. It was a nightmare.”
*
Those in the agency who rebelled against WordPerfect urged a switch to Microsoft Word, a competing system. When Kessler asked for advice in the Los Angeles computer specialty store, he was told: “Use [Microsoft] Word.” That was that.
As for what the regulations actually said, the FDA published its proposed regulations a year ago and asked interested parties to comment on them. Within hours, comments arrived on the FDA’s doorstep by the truckload: letters from 30,000 schoolchildren applauding the idea, for example, and 300,000 letters from race car fans opposing it for fear that losing cigarette sponsorship would damage their sport.
The tobacco industry piled on more than 45,000 pages mustering every constitutional argument imaginable against the FDA’s assertion that it has jurisdiction to regulate cigarettes.
No one actually kept a count of how many comments favored the regulations and how many opposed them, although opponents typically are more vociferous than supporters. Regardless, an FDA official said, the public comment process “is a substantive review, not a vote.”
Every comment was read and, if necessary, discussed.
The FDA formed two teams to work on the issue.
One, informally headed by Kessler, concentrated on the basic question of agency jurisdiction: Could the agency document the legal and statutory underpinning for its contention that it had authority over nicotine as a drug and, thus, over cigarettes as drug delivery devices.
A second team, informally led by Bill Schultz, deputy commissioner for policy, focused on the contents of the regulations themselves. One subgroup read and summarized the thousands of comments and isolated specific issues that needed to be addressed. Another dealt with the larger policy questions.
“Millions of issues were brought up with the comments and we had to make decisions as to what the policy call was going to be as we went along,” said one member of the regulation team. “For example, one of the comments said: ‘Why are you proposing to ban vending machines in places like bars, where kids don’t go?’ ”
Ultimately the FDA decided this was a valid point. The final regulation bans cigarette vending machines only in locations frequented by teenagers. It allows them in bars, for example, but not in grocery stores.
The documents were sent to the Office of Management and Budget for clearance two weeks ago. At OMB’s direction, changes were made until Thursday.
*
“OMB had suggestions and we’d talk about it or we had to check cites and get the parentheses just right,” said an FDA official. “And there were people who just couldn’t resist reading their sections again.”
A final footnote to the software debate: The Federal Register, which publishes all government regulations, cannot accept submissions written on Microsoft Word.
“So in the end we had to switch back to WordPerfect 6.1,” said an FDA official who had resisted the switch to Word. “So, in a sense, we both got our way.”
