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BOLAR INCITES CONGRESSIONAL ANGER BUT MAY HAVE DODGED FOLLOW-UP HEARING; FULL-PAGE AD AGAINST DINGELL BRINGS OUT CHARGES OF PRODUCT SWITCHING

Executive Summary

Bolar's newspaper ads questioning Chairman Dingell's investigation into the generic drug industry brought down a torrent of criticism and bad press coverage from the Sept. 11 hearing of the House Energy & Commerce Oversight Subcommittee. The panel's Ranking Republican Bliley (R-Va.) took an opening shot at Bolar in his prepared statement at the start of the hearing. "Bolar would be better advised to deal with this situation in a more constructive and responsible manner than that evidenced by the text and tenor of the ad." Bolar had violated one of the first unwritten rules of Congressional inquiries by publicly chastising the inquisitor. In its full-page ads, Bolar said the company is "outraged at U.S. Representative Dingell ]D-Mich.[ and his Subcommittee on Oversight for creating a climate of fear and distrust within the entire generic pharmaceutical industry because of the fraudulent deeds of a few." Ironically, Bolar may have dodged a worse follow-up hearing by drawing the open ire of the subcommittee at the Sept. 11 session. Bolar had been scheduled as the lone corporate witness at a hearing set for Sept. 29, but the subcommittee may have already spent some of its force against the company in response to the ads. Bolar's assertion in the ads, Bliley said, "is puzzling at best. Chairman Dingell, on behalf of the subcommittee, acted responsibly by forwarding to FDA certain documents which suggested that Bolar may have switched the brandname drug for its own, or otherwise actedly improperly in obtaining approval for its version of Dyazide." FDA, he continued, "based on its own independent review, has since notified Bolar that it intends to withdraw approval for Bolar's product. Not surprisingly, the ad failed to mention these facts." Bolar President Robert Shulman and company representatives met with FDA staff on Sept. 12 to discuss the agency's proposal to withdraw the firm's ANDA for its generic Dyazide and FDA's downgrading of the product's therapeutic equivalence rating to "BX" or nonequivalent. One of the allegations against Bolar made at the Sept. 11 hearing is the possible submission of branded thioridazine to an outside contract lab in 1982. Bliley questioned FDA Deputy Director of Generic Compliance Paul Vogel about a 1982 letter from the contract testing lab, PharmaKinetics, to its client Bolar stating that the thioridazine tablets that the firm sent for a bioequivalence study "are not of your production" and that this conclusion had been reached on four previous batches (text of the PharmaKinetics letter below). Vogel showed the subcommittee photographs of two different thioridazine tablets. One was the innovator product, Sandoz's Mellaril, which has the logo of an "S" in a triangle. Vogel held a second photo of another tablet, purportedly from a Bolar lot, shipped to PharmaKinetics. "You can tell very faintly on that tablet the appearance of a . . . triangle and you can pick up some indication of an S." Vogel also described photos of tablets from four different lots of purported Bolar material, in which the triangle/S logo was discernible to varying degrees. FDA's lab, Vogel said, determined that "the markings appeared to be on the surface and not overcoated . . . that in general the Bolar purported tablets were generally less shiny and slightly smaller." The FDA analyst believes this is a "result of some kind of operation to remove the logo itself," Vogel pointed out. Bliley said the information "further undermines the credibility of Bolar's story." The congressman was referring to Bolar's explanation to FDA that Sandoz' tablets were inadvertently mixed in with Bolar's tablets during the coating operation. Bolar was scheduled to appear before the Dingell subcommittee in a difficult setting with Attorney General Thornburgh on Sept. 29. However, with one of the major allegations against the firm already used at the Sept. 11 hearing, that hearing may not materialize. The hearing is more likely to be held if the Justice Department succeeds in wresting away from HHS authority for enforcement of felonious FD&C Act violations. In a government turf-battle, Justice is trying to maintain the prerogative to pursue felonies of the FD&C Act. The House subcommittee supports the work of the HHS Inspector General. In July, HHS transferred authority for such criminal investigations from FDA to the Inspector General ("The Pink Sheet" Aug. 7, p. 8). A Justice Department opinion last March advised against a similar proposal under which the Labor Department would share enforcement authority with its Inspector General Office. Justice reportedly believes that the HHS Inspector General should not have line authority to enforce FDA programs and that enforcement for felonious violations might be better enforced by the Federal Bureau of Investigation, a Justice Department agency. The subcommittee is said to be concerned that FBI would be unlikely to assign its resources to offenses such as violations of ANDA regs. There are other attractions that might make Bolar miss a hearing date. The House subcommittee is also reportedly looking into a tailor-made hearing topic: the purchase of steel from South Africa by the Transportation Department to build a bridge in Texas in the memory of the late Rep. Mickey Leland. The question of whether the Bolar investigation gets a hearing on its own later this month is of broad importance to the industry. The Dingell drug hearings may have begun to run their course. If there is no hearing on Bolar, then the public furor over the generic investigations may quiet. There are signs that other Dingell investigations could continue to batter FDA. His subcommittee has asked for extensive inspection material on Lilly (see related story). The subcommittee is also actively investigating problems with abbreviated approvals in the device field. In a Sept. 14 speech to one of the major trade associations representing the medical device industry, Dingell said that his subcommittee intends to hold hearings on FDA's enforcement of the device amendments by the end of this year. Dingell was asked whether he expects to find abuses similar to those in the generic drug reviews. The congressman said: "I don't think that we are going to find" problems such as payoffs to product reviewers. However, he said that FDA appears to be "arbitrary and capricious" in its implementation of the device statute. PHARMAKINETICS DECEMBER 6, 1982 LETTER TO BOLAR ON MELLARIL TABLETS Following is a reproduction of the letter from then PharmaKinetics President Alan Woodman addressed to Bolar VP Jack Rivers I am writing this letter to confirm our phone conversation today, and more importantly, to stress the seriousness of the thioridazine matter as it affects your company and mine. Specifically, my technical staff here has concluded that the tablets which you sent for the bioequivalence study are not of your production. This same conclusion was reached on your batches #012367, #012358, #022390 and #022389, and you were so notified by phone. Under the present circumstances, we are refusing to execute the protocol as we refused on two previous occasions. As requested, we are returning the tablets under separate cover. You have to know that if information comes to our attention that a drug approval is obtained by irregular means, we are no longer ethically or legally bound by the Confidential Disclosure Agreement which exists between our companies. PharmaKinetics is not the keeper of morality in the pharmaceutical industry, but rather a small company which really needs your business. But Jack, you are an important part of an American success story, and it's our opinion that the exposure you place yourself and your company by pursuing this course of action far outweighs any possible benefit which may accrue to you or the company. Please rethink your position on this, and let's get on to a valid bioequivalence thioridazine tablet study using test product from your production.
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