Well, autumn is definitely here. The fireplaces have once again been lit. Thanksgiving is just around the corner. And this week, Congress discovered it had a backbone when it overrode a presidential veto for the first time. Anything can happen.
Here is a little bit of what happened on our front this week:
- FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs) – A class of drugs that treat severe anemia in patients who have End Stage Renal Disease or have undergone chemotherapy, received a new boxed warning label this week from FDA. These drugs, that include Epogen, Aranesp and Procrit had warnings addressing each specific use. According to the release – for patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater" and "for patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk for death and for serious cardiovascular reactions such as stroke, heart attack or heart failure, the boxed warning states." A Medication Guide is also apparently in the works.
- Regulation by Legislation – Congressman Henry Waxman and Senator Edward Kennedy have introduced legislation called the "Non Prescription Drug Modernization Act" that would speed up regulatory action by the FDA should the agency wish to follow the recommendation of a recent FDA Advisory Panel on children’s cough and cold medications. In essence, the bill would allow FDA to bypass the current lengthy procedure for addressing the Non-Prescription Drugs Advisory Committee’s recommendation to remove these OTC drugs as well as give it authority to levy fines against those who advertise such drugs.
- GSK Gets Thumbs Down on Depression Drug – The FDA issued a not-approvable letter to GlaxoSmithKline in response to the company’s application for gepirone ER for the treatment of depression in adults. In a press release titled "Fabre Kramer Pharmaceuticals receives decision from FDA on gepirone ER for major depressive disorder" (no sense in putting the bad news in the headline, I guess), it was stated that the clinical trials had been reviewed by the FDA in 2004 and additional data was requested. That was submitted and reviewed by the agency prior to making their decision.
That’s it for this week. Have a good weekend everyone.