PBM Guidance Will Be Among Labor Cmte. Topics For Commissioner Nominee

The FDA commissioner confirmation process will involve questions about the agency's guidance on promotion by pharmacy benefit management companies, Senate Labor & Human Resources Committee health policy director Jay Hawkins said.

Speaking May 15 at the annual meeting of the Medical Device Manufacturers Association in Washington, D.C., Hawkins suggested that "the chairman [Sen. Jeffords (R-Vt.)] and many of his colleagues will be...interested in getting the answers to questions about things like the PBM draft guidance" as part of the confirmation process.

Jeffords co-signed a letter to acting Commissioner Friedman in April questioning the basis for the agency's January guidance on promotions by health care organizations and PBMs ("The Pink Sheet" April 27, p. 11).

The committee expects that "the nominee will be sent up in the next few weeks," Hawkins observed.

The Administration's selection of University of New Mexico VP-Health Sciences Jane Henney for the top FDA slot is imminent: a May 19 New York Times article on her selection served as an informal announcement of choice for the Administration.

Henney was said to have been notified of her selection by President Clinton in early March ("The Pink Sheet" March 16, p. 12). A Federal Bureau of Investigation background check into the proposed nominee is understood to have been completed.

By discussing Henney's selection informally at the time of the American Society of Clinical Oncology meeting in Los Angeles, the Administration was able to capitalize on the enthusiasm for cancer research in the media by highlighting Henney's background as an oncologist.

Henney's clinical specialty lent immediacy to the media reports of her selection, but will not represent a change from the status quo at FDA. Friedman is also an oncologist.

The focus on Henney's oncology specialty may make FDA regulation of communications an especially prominent issue in the confirmation process.

Henney's predecessor at FDA, David Kessler, staked out an aggressive enforcement position in part by challenging the industry's approaches to communication of off-label information in the oncology field.

The agency's investigation of a Bristol-Myers Squibb-funded oncology publication led to its policy statement on appropriate forms of scientific exchange.

The political fall-out from that action by FDA culminated in the information dissemination provisions included in the FDA Modernization Act of 1997. Under the new law, companies will be allowed to promote off-label indications based on medical journal publications.

Questioning for Henney from the Republican majority is likely to focus on her commitment to allowing the free exchange of scientific ideas.

The pressure from within the agency, however, will likely be how to reign in the promotion-by-media that occurred during the ASCO meeting.

Sen. Frist (R-Tenn.), a Labor Committee member and primary author of the information dissemination provisions in the FDA Modernization Act, can be expected to take a particular interest in Henney's stance on the regulation of product information. He co-signed the Jeffords inquiry letter on the PBM guidance.

PBM-owning manufacturers have been able to use their diverse geographic locations to generate a number of inquiries from Congress about the PBM issue.

Merck, for example, has significant pharmaceutical manufacturing operations in Pennsylvania, and its Medco subsidiary has a large presence in Ohio. Sens. Specter (R-Penn.), Santorum (R-Penn.) and DeWine (R-Ohio) have sent letters to the agency about the guidance. DeWine is a Labor Committee member. Specter and Santorum also have SmithKline Beecham as a constituent; SB owns DPS.

Labor Committee member Coats (R-Ind.) has also inquired about the PBM guidance. His home-state constituent, Lilly, owns a PBM. Lilly has also generated inquiries from the two Arizona senators, McCain (R) and Kyl (R), based on PCS' large presence in that state. Rep. Hayworth (R-Ariz.) has also sent a letter on the issue to FDA.

Other inquiries have come from Sen. Helms (R-N.C.), representing the concerns of Blue Cross/Blue Shield of North Carolina, and Rep. Moran (D-Va.), expressing concern that the policy will raise insurance rates for federal workers by ending rebates. Merck manufactures Crixivan in Virginia.

The Labor Committee plans to use the confirmation process as its primary oversight of the implementation of FDAMA, Hawkins indicated. "By and large, [Jeffords] and his colleagues are going to use any confirmation process as the oversight tool."

The confirmation process is likely to focus on specific questions about FDA policies rather than on the qualifications of the nominee, Hawkins suggested. "Let's get the answers to those first and then we'll talk about...how that person will fulfill" the position, he declared.

In remarks delivered at the MDMA meeting, Frist stressed the importance of finding a nominee who will establish the appropriate "culture" at FDA.

The next commissioner "must be committed to this concept of ongoing and prudent modernization" of the agency, Frist said. The candidate needs to have "sufficient...managerial expertise because this agency is changing, is large and is complex," he explained. "We don't need somebody there who fears change, who wants to slow down the process, and that's going to be a challenge."

"I think we need to get somebody in that position who is respected by" the device industry, Frist continued. Frist called for "that same sort of trust" that exists between a doctor and a patient to exist between the commissioner and industry.

MDMA is one of few organizations openly opposed to Henney for the position of Commissioner. The organization cited Henney's role in the breast implant controversy and in developing more stringent clinical data requirements for device submissions in a December letter to HHS Secretary Shalala.

The emphasis by Frist on the appropriate "culture" at FDA echoes the comments of Sen. Mikulski (D-Md.) during the Pharmaceutical Research & Manufacturers of America annual meeting May 11. Mikulski is a member of the Labor committee.

Another focus of the confirmation process will be FDA's priorities for non-user fee resources. The agency is undertaking potentially expensive new initiatives in tobacco regulation and food safety without the prospect of substantial budgetary increases.

Sen. Bingaman (D-N.M.) has said that he will ask about funding for research within the Center for Biologics Evaluation & Research.

FDA's Science Board is recommending that the CBER research budget be restored to 1994 levels.

On the device side, the Labor Committee wants FDA to use the third-party review provisions set up under FDAMA instead of seeking more resources, Hawkins told the MDMA conference.

"The whole point of the third-party program is that we don't want FDA levying user fees," Hawkins explained. "That is the alternative that Congress prefers, and [FDA] should use it as a tool to reduce their workload."

Calling the program a "safety valve for the agency to help it prioritize" in an era of fiscal restraints, Hawkins said FDA "is going to have to do what we wanted them to do, which is to use" FDAMA "to be smart and be efficient and put their resources where they are most needed."

FDA should maintain communication with industry as it implements reforms under the Modernization Act, Hawkins added.

Industry has complained that it has been shut out of much of the discussion regarding policy changes at FDA related to the law due to the agency's fear of violating the Administrative Procedures Act.

The Jeffords staffer deemed it "troubling" that the agency "seems to have difficulty squaring the [APA] with the obvious need to communicate with you all."

Hawkins emphasized that FDA's communications policy "needs to cut across the board. Public Citizen shouldn't be getting a better deal than you guys, or vice-versa," he said.