Drug companies oppose switch for antihistamine drugs to otc

Schering-Plough and Aventis Pharmaceuticals have opposed a petition to switch non-sedating antihistamine drugs, including Aventis' Allegra (fexofenadine HCl) and Schering-Plough's Claritin (loratadine), from prescription to otc status.

The companies disagree with the petition from the Well Point/Blue Cross insurance company of California, US, because, as Aventis puts it, 'there is no compelling health or medical need to force these products otc and taking the doctor out of the equation is not good for the patient.' The companies claim that experts agree correct diagnosis by a physician is vital, so the switch to otc could have an adverse impact on patient care.

As Schering-Plough says, 'Encouraging patients to self-diagnose and self-treat a complex and chronic disease that often is associated with more serious conditions such as asthma is not in the patients interest.'

The companies also point out that patients would shoulder the costs of the transfer to otc, with the costs shifting from the insurance company directly to the consumer. Based on the testimony of experts, Aventis believes that this could result in a 'lesser quality of healthcare' for those patients with an allergy. The greatest impact will be felt by the insured population, it believes, which account for the majority of American patients, who will have to pay for their medication that is currently covered by insurance premiums.

Another point that Aventis raises is that it was not 'given adequate notice and opportunity to address and prepare for the complex issues related to this switch'. Schering-Plough commented that 'the petition lacks the data of the type or rigor that is required to support an otc switch. Extensive data is required to support such a switch and demonstrate that a drug can be used safely and effectively, with proper labelling on a non-prescription basis. The company strongly asserts that the Blue Cross petition lacks such data'.

Traditionally, an otc switch is initiated by the manufacturer with the filing of a comprehensive submission containing data from various studies, including actual use and labelling comprehension studies, together with proposed labelling.