CAPITOL HILL INTEREST IN MANUFACTURER RELATIONSHIPS WITH NON- PROFIT ASSOCIATIONS LIKELY TO WANE AS REPUBLICANS SET HEARING AGENDAS IN NEW CONGRESS

Congressional scrutiny of drug industry relationships with non-profit associations is an example of the type of pending political challenge to industry practices that died on Nov. 8 with the shift in power to a Republican-controlled Congress.

Rep. Wyden (D-Ore.) has been the most vocal critic of possible promotional activities performed by non-profit disease organizations affiliated with private industry. He has shown particular interest in Genentech's marketing of its human growth hormone Protropin and connections to the non-profit Human Growth Foundation, which funds growth screening programs.

At an October hearing of the Small Business/Regulation Subcommittee addressing Genentech's arrangements with the foundation, Wyden asserted that such programs, "when so closely linked to the manufacturer and, in some cases, to the local prescribing physicians, represent a marketing effort" ("The Pink Sheet" Oct. 17, p. 3). Wyden was satisfied with the company's decision to halt its pediatric weight and height screening programs prior to the hearing ("The Pink Sheet" Oct. 10, T&G-I).

With the Republican ascension in the 104th Congress, Wyden's plans for future hearings on drug industry promotion were put on hold. Wyden had tentatively expected to conduct a follow-up hearing in January.

Also out of favor will be attempts to find indirect ways into drug price controls through collaborations such as the NIH Cooperative Research & Development Agreements.

Wyden had set the stage for broad-ranging hearings on marketing and promotion of drug products, asserting the existence of "a pattern of organized state-of-the-art marketing abuses" within the drug industry. The Oregon Democrat's interest in promotional practices could have dotted the 1995 congressional calendar with hearings on such issues as: promotional efforts of independent managed care groups; manufacturer/PBM promotional activities; and penalties for violative drug promotions.

The October hearing also highlighted Warner-Lambert's relationship with the Alzheimer's Association. The non-profit association has established an agreement with Warner-Lambert to administer a research fund based on sales of the company's Alzheimer's treatment Cognex (tacrine). Testimony focused on alleged marketing activities carded out by the association in support of Cognex.

The Hill investigation into Genentech's promotional practices spawned a shadow effort on the subject at FDA. The FDA effort was recently extended to the marketing of Activase (alteplase, t-PA). Genentech has been supplying Activase-related educational and advertising materials to FDA for several months, the company disclosed Nov. 10.

In June, FDA's Cardiovascular & Renal Drugs Advisory Committee concluded that GUSTO trial mortality data showing Activase superiority over streptokinase could be included in the drug's labeling for thrombolysis in acute myocardial infarction ("The Pink Sheet" June 13, T&G-1).

Energy & Commerce/Oversight Subcommittee Chairman Dingell (D- Mich.) had shown interest in Genentech's inclusion of GUSTO data in Activase labeling, which had helped boost market share in the thrombolytic therapy market.

While FDA's activities will not go away because of the Congressional changes, FDA will probably begin to show less interest in the subjects without being egged on by aggressive Hill investigators. In the area of CRADAs, the champion of past hearings were Sen. Pryor (D-Ark.) and Reps. Wyden and Waxman (D- Calif.). A revisitation of the issue in the next session may more closely resemble the approach taken by industry, that the "reasonable price" clause required for CRADAs inhibits active technology transfer.

In other areas, Rep. Towns (D-N.Y.) had planned for his Government Operations/Intergovernmental Relations Subcommittee to take an active role in the 104th Congress in at least two areas: examining FDA's decision to halt an investigation of Upjohn's Halcion NDA data; and investigating the NIH's clinical trial of Lilly/Oclassen's FIAU.