Pharmaceutical company pricing actions do not provide a basis for the National Institutes of Health to cancel exclusive licensing agreements, the agency said in turning down a request to exercise "march-in" rights for Abbott's Norvir .

The test for a "march-in" decision is "availability," not pricing, NIH said.

"Norvir has been available for use by patients with HIV/AIDS since 1996 and is being actively marketed by Abbott and prescribed by physicians primarily as a booster drug. Accordingly, this drug has reached practical application and met health or safety needs as required by the Bayh/Dole Act," an ¹ NIH position paper states.

Issues of pricing are more appropriately left with the Federal Trade Commission and Congress, NIH declared.

"The extraordinary remedy of march-in is not an appropriate means of controlling prices," NIH says. "The issue of drug pricing has global implications and, thus, is appropriately left for Congress to address legislatively."

"NIH is aware that members of Congress and the public have asked [FTC] to investigate the potential anti-competitive effects of the increase in the price of Norvir. The NIH agrees that the FTC is the appropriate agency to address this issue."

In May, NIH convened a meeting to hear public comment on whether "march-in" authorities should be used to grant compulsory licenses of Norvir (ritonavir). Under Bayh/Dole, NIH can grant compulsory licenses to products developed using federal funds if they are not made available to the public (² Also see "Norvir Federal Grants Were Roughly 1% Of Development Costs, Abbott Says" - Pink Sheet, 25 May, 2004.).

The non-profit group Essential Inventions submitted a petition in January requesting NIH exercise the "march-in" authorities. The petition was filed in response to a December price increase for Norvir from a wholesale acquisition price of $1.71 per day to $8.57 per day.

Abbott maintained during the hearing that the change in Norvir's price reflects a change in use from a stand-alone therapy to a booster therapy, as well as the product's increased clinical value when used in combination with other HIV agents.

Abbott received a warning letter from FDA on June 10 regarding its defense of the Norvir price increase. The chart compared the cost of Norvir's booster dose (100 mg once daily) to higher labeled dosing regimens of other antiretroviral agents (³ Also see "Abbott Norvir Cost Chart Misrepresents Therapeutic Dose, Price – FDA Warning Letter" - Pink Sheet, 11 June, 2004.).

Essential Inventions is appealing to HHS Secretary Tommy Thompson to reverse NIH's decision.

- Adam Eckstein

Norvir Exclusivity Is Safe; NIH Says "March-In" Test Is Availability, Not Price

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