Rep. Barton targets former FDAers in conflict-of-interest inquiry.

REP. BARTON TARGETS FORMER FDAers IN CONFLICT-OF-INTEREST INQUIRY in a July 12 letter to FDA Commissioner David Kessler. The letter asks for conflict-of-interest documents on former FDA Division of Manufacturing & Product Quality Director Paul Vogel and former Office of Generic Drugs Acting Director Robert Pollock. Both are currently employed at Westbury, N.Y.-based Lachman Consulting Services, which specializes in good laboratory practices, good clinical practices, good manufacturing practices regulations, regulatory affairs and the resolution of compliance problems.

One "case of at least the appearance of conflict-of-interest" involves the use of consultants by FDA's Center for Drug Evaluation & Research and "at least certain FDA district offices to verify the integrity of the application and compliance process," House Commerce/Oversight Subcommittee Chairman Joe Barton (R-Tex.) suggested.

"In this specific case," Barton continued, "we are concerned that two former high ranking CDER employees have left the agency to take positions with one of these consulting firms that may well have benefited from the recommendations of these individuals while they worked for the agency."

The letter notes that while Vogel was acting director of the Office of Generic Drugs, he "was reportedly the FDA official who chose consultants for the internal audits conducted by generic drug firms or their lawyers to determine if their submitted ANDAs were fraudulent." Barton suggested that Pollock "may also have been in a position to determine which consultants would be acceptable to review validation and other pre-approval inspection data."

In response to the Barton letter, Pollock said that the Office of Generic Drugs' policy was never to recommend a consultant to any company, but instead to refer drug sponsors to the generic drug trade associations. Pollock said he never recommended any consultants while at FDA.

Barton specifically asked FDA to provide him with: "(1) current FDA conflict-of-interest documents relating to [Vogel and Pollock's] previous and subsequent employment"; (2) a list of consultants recommended by the two FDAers from Jan. 1, 1992 until their departures from the agency; and (3) "a list of all product review and compliance activities that FDA permits outside consultants to perform and a corresponding list of FDA officials empowered to approve, recommend, or effectively recommend such consultants."

Vogel joined Lachman, Inc. in November 1993 after serving at FDA for over 20 years in the field and at headquarters. Pollock left FDA in January to join Lachman after 10 years of service in the office of generic drugs.

Rep. Barton also suggested "at least the appearance of conflict of interest" is raised by the involvement of Associate Commissioner for Legislative Affairs Diane Thompson in FDA decisions regarding Wyeth-Ayerst's Premarin (conjugated estrogens) because of her previous association with Washington, D.C. lobbying firm Foreman & Heidepriem, which has been lobbying for acceptance of Wyeth-Ayerst's petition on necessary components for generic conjugated estrogens.

Barton declared that although "Thompson's role in FDA decisions concerning Wyeth-Ayerst is not entirely clear," it is "clear that Ms. Thompson has not recused herself from the conjugated estrogens issue." Thompson signed a June 15 response to Reps. John Dingell (D-Mich.) and Ron Wyden (D-Ore.) on FDA's policy on generic conjugated estrogens.

Barton set a July 26 deadline for FDA to provide information including: Thompson's last date of employment at Foreman & Heidepriem; when and whether Thompson severed all financial ties to the firm; "unexpurgated copies of Thompson's SF-278 financial disclosure forms filed" during employment with FDA; and documentation of FDA decisions affecting Premarin, including "all communications relating to Wyeth-Ayerst's Premarin sent to or by Ms. Thompson or mentioning her name."

Kessler also was asked to provide a "written opinion as commissioner" on whether he believes it was "prudent" for Thompson "to participate in the particular matter of Premarin involving Wyeth-Ayerst," given his "interest in ensuring the integrity of FDA's decisions." Barton also requested information on whether Thompson "received prior authorization to participate in certain matters involving parties represented by Foreman & Heidepriem." In a tone uncharacteristic of Congressional correspondence to FDA, the letter adds: "I trust that you will assure that someone other than Ms. Thompson is put in charge of responding to this request."

In a July 13 letter to HHS Secretary Donna Shalala, Barton requested that the HHS assistant secretary "take over the task of assuring that documents requested from FDA, both for this particular matter and all other matters where they are delinquent, are produced forthwith."

The letter complains that Kessler's office "has been strangely silent" in response to a June 30 request for information on Earl Wright Company's Sensor Pad, a medical device used to detect breast lumps. Regarding the June 30 request, Barton urged that, "given the problems we have encountered with the timeliness and completeness of document requests that have been routed through your Office of Legislative Affairs," someone in the commissioner's office should ensure that both "requested documents and interview requests are fully complied with" by specified deadlines.

Instead of a reply, Barton said, subcommittee staff "received a token phone call from FDA's Office of Legislative Affairs to indicate they would be handling document requests and interviews." On the July 10 deadline set by the subcommittee, "I received a letter from the Associate Commissioner Diane Thompson essentially stating that FDA was unable to respond to my request because insufficient facts were provided in the letter," Barton complained.

"In essence," Barton concluded, "Ms. Thompson's July 10 letter repudiated Dr. Kessler's commitment to this committee that he would not tolerate retaliation in any form. Instead it appears that Dr. Kessler and his legislative and legal advisors have retreated to a position that FDA itself will determine both the timing and extent of investigations of its employees. This is entirely unacceptable."

"The failure to produce requested information on a timely basis has seriously interfered with this subcommittee's investigation of FDA retaliation," Barton declared. The subcommittee has scheduled a hearing on the subject of FDA retaliation for July 25 ("The Tan Sheet" July 10, p. 16).