Abbott receives warning from FDA over ritonavir price claims

11 June 2004

Estimated reading time 2 minutes

Abbott Laboratories has received a serious warning from the US Food and Drug Administration over recent US promotional material that sought to portray its protease inhibitor ritonavir (Norvir) as the cheapest antiretroviral on the market – just months after the company had increased its price fivefold in the United States.

The FDA this week wrote to Abbott, warning the company to stop cicrulating promotional material that includes a bar chart comparing prices of different antiretroviral drugs. The chart appears to suggest that Norvir is the cheapest option at a daily price of $8.57, compared with a daily price of $22.08 for Reyataz (atazanavir), a protease inhibitor recently launched by Bristol Myers Squibb.

However, examination of the small print shows the comparison to be `false or misleading`, says the FDA, since the chart compares the cost of a sub-therapeutic dose of Norvir (the 100mg dose used to boost some other protease inhibitors) with the licensed full doses of other products.

Glossary

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

subtherapeutic

Refers to a dose or blood concentration of a drug that is too low to be effective.

Although the promotional material was aimed at doctors, the FDA notes its concern over the effects that misleading comparisons between subtherapeutic doses might have on the HIV community.

In its most audacious comparison the chart suggests that it is legitimate to contrast the prices of Trizivir – a three drug combination tablet – and Norvir (at a subtherapeutic dose). The FDA points out that Trizivir is the only product featured in the chart to have been licensed for use on its own, because it is a combination of three antiretrovirals. None of the other drugs in the chart should ever be used alone, says the FDA, so the comparison is misleading and might give the impression of promoting a subtherapeutic dose of Norvir in the absence of any other prescribing information in the promotional material.

The warning comes two weeks after the US National Institutes of Health held public hearings to determine whether it should grant `march-in` rights on Abbott’s ritonavir patent to allow other companies to manufacture the drug more cheaply. The NIH's Technology Transfer panel is due to issue a recommendation shortly.