FDA PREVIEW OF Rx DRUG PRESS RELEASES ARE CONDUCTED WITHIN "REASONABLE" TIMEFRAME, AGENCY MAINTAINS; APPROVAL NON-BINDING IF MATERIALS CHANGE

FDA's review of prescription drug introductory press materials will take a "reasonable" amount of time, Arthur Yellin, assistant to the director of FDA's Drug Advertising and Labeling Division, told a Jan. 25 Food and Drug Law Institute seminar in Washington, D.C.

When firms submit press information on drug launches for FDA review, Yellin noted, some expect "instant or curbside service. This is unreasonable." He noted that "just as it has taken them many long hours to develop the materials, we require a reasonable amount of time to consider them and offer an intelligent response."

Burson-Marsteller Exec VP Wayne Pines emphasized the need for an "understanding" between FDA and industry on how long such a review would take.

Pines, a former FDA Associate Commissioner for Public Affairs, pointed out: "It is difficult for the agency to render an opinion on advertising or press materials until after the final labeling is approved, but the press kit almost always has to be available on the day of approval." Burson-Marsteller, Pines noted, "has spent many a late night pulling apart and restuffing press kits based on last-minute changes requested by FDA."

FDA will be taking a tougher stance on its position that preapproval of press releases is not binding if the materials have been changed substantively at the time of issue, Yellin stated.

"It is unfair to provide us with materials in a rough form and request our preclearance when the materials finally used differ significantly," the FDAer said. "We are currently developing a hardened policy with regard to such requests, because they have become a problem."

Yellin added: "We intend to make it very clear to requesters that our opinion is neither official nor binding to any extent unless we are given a reasonable length of time to review the actual materials in a form substantially identical to the form ultimately used."

Press materials on development phase drugs must avoid promotional overtones, Yellin emphasized. "We would probably look very dimly on a firm promoting or having significant press activities when a drug is very early on in development and looks promising," he said. "If you portray it as if it were absolutely safe and effective, that is going to get our attention."

FDA would disagree with assertions that companies are completely exempt from blame over the way drug development information is reported by the media, Yellin stated.

He pointed out: "One firm at least has tried to divorce itself from responsibility of what we see and hear on news broadcasts. In fact, as far as we are concerned, the sponsors and their public relations firms have a great deal of control over what is ultimately broadcast."

FDA Drug Advertising Regulation Chief Kenneth Feather addressed the subject of medical seminars, symposia or "sole-sponsor" publications. Feather told the meeting: "We have tried to establish some working guidelines as to what kind of programs we won't object to or may raise objections to."

A key element of FDA's review focuses on "the independence of the material that is being produced," Feather said: "How independent is the editorial board? Does the sponsoring firm have any veto rights or review rights over the kind of materials which are being presented? Do they suggest or veto speakers?"