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Sanders, Other Lawmakers Urge FDA Approval of Generic Crestor

Two months ago, AstraZeneca gained approval for the use of Crestor in children suffering from homozygous familial hypercholesterolemia (HoFH) and, under the Orphan Drug Act (ODA), the drug then qualified for extended market exclusivity for the treatment of this new condition. With the impending loss of patent protection for Crestor’s common use in adults, AstraZeneca has filed a lawsuit accusing the FDA of illegally interpreting a federal law that will allow generic medications to exclude indications for HoFH on their labels. Without the ruling, generic manufacturers would be required to include HoFH dosing and instructions on their labels, therefore violating the exclusivity granted by the ODA and extending AstraZeneca’s market hold. Bernie Sanders, along with several other lawmakers, are petitioning the FDA to approve the generics and offer a lower cost alternative to consumers.

Read the Stat News article on it here.

[Podcast from 2 Docs Talk] Direct-To-Consumer Marketing - Letting the Fox Guard The Henhouse

Summary: Direct-to-consumer drug marketing has, historically, been a controversial topic. In 2002, Merck spent $160 million on a marketing campaign for the new pain medication, Vioxx. Later, the drug was found to increase the risk of stroke and heart attacks and was being used, largely, by individuals who were well-suited for alternative drugs (like ibuprofen). In addition to the increased potential for misuse, many ad claims are misleading for consumers: A reported “significant” increase in length of life for patients on a treatment for lung cancer is actually three months. As pressure builds to regulate, or even halt, these advertising practices, the pharmaceutical industry has a proposed solution. They recommend giving the FDA approval rights for all prescription drug ads prior to their release, funded by manufacturers through a per ad ‘user fee.’ This approach is already used for drug approvals, with manufacturers funding over half of the FDA’s budget; prior to the implementation of these fees in 1993, drug company investment accounted for less than 10% of funds received by the FDA. Opponents of the measure are concerned how the impact of additional pharma industry funding will jeopardize the ultimate efficacy of the FDA’s practices.

Here the podcast from 2 Docs Talk here.