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Executive Summary

HHS REFERRAL OF INDUSTRY CONTACTS BACK TO FDA is a common procedure when questions about agency decisions are brought directly to the dept. level, FDA Chief Counsel Thomas Scarlett maintained in remarks to a Food & Drug Law Institute seminar March 28 in D.C. Asserting that "there are several things wrong about jumping out of the decision making chain," Scarlett said that when issues are brought to the dept. "you are likely to be putting in a plea to somebody who hasn't got the vaguest idea of what you are talking about." He added that a "Dear Mrs. Heckler" [HHS Secty.] letter "is going to be routed straight back to the FDA for a response." Scarlett continued: "Usually by the time the frantic plea for a meeting arrives in the department, the department already has before it a memorandum from FDA that demonstrates with great precision and immense scientific erudition how incredibly correct its position is." He said a meeting with the secty. is not going to make it easy for her to do what a company wants her to do. "Several times in the past few months I've seen situations in which the idea of meeting with the secty. was exactly the wrong thing to do from the point of view of the person who was seeking the meeting," Scarlett stated. Scarlett acknowledged that appeals to the agency to reconsider a prior decision have very little chance to be reversed. But he maintained that the reason is primarily because of the substance of the requests, not the procedure itself. Scarlett said that "when you file for reconsideration at FDA, you're about as likely to get a changed answer as you are when you file for reconsideration in court -- something above zero, but not much." However, he said reconsideration is not legally necessary before one goes to court. Scarlett added that "as far as the track record on actions and petitions for reconsideration is concerned . . . as soon as we have a petition for reconsideration that is meritorious, we'll give it our closest attention." Scarlett's comment on the reconsideration procedure was in response to a statement from Procter & Gamble Senior Counsel James O'Reilly, who said that "a skeptic who reads the record would say that FDA's reconsideration of final decisions is a sham." He added that "the FDA uses it as a nice tactical device" to delay court appeals. In a separate presentation, D.C. lawyer Jonah Shacknai (Royer & Shaknai) asserted that Congressional investigations of FDA's approval of Zomax and Oraflex, both conducted by Rep. Weiss (D-NY), have "stymied the advances in progress that have been made in the drug approval process." Shacknai contended that Weiss "has really returned the agency to the shell shock mentality . . . it experienced in the early '70s when Congressman Fountain and Sen. Kennedy were almost doing weekly hearings, second guessing every drug approval." Shacknai noted that in the last calendar year "not one non-steroidal anti-inflammatory was approved by the agency." He suggested FDA is "too concerned about the potential congressional reaction to go ahead and approve drugs to take a chance." He said agency personnel are "scared to their wits of getting called up before a congressional cmte. and having to justify a decision which at the time seemed to make good sense scientifically," but with "experience in hundreds of thousands of patients may turn out to be a bad decision."

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