FDA too slow to protect Fosamax patients’ health
September 22nd, 2012 7:00am
On September 9, 2011, a joint FDA Advisory Committee voted overwhelmingly, 17 to 6, to recommend that the United States Food & Drug Administration include stronger warnings on bisphosphonate drugs, such as Fosamax. The proposed and requested warnings would emphasize the lack of long-term fracture reduction benefit from Fosamax.
In their review of the clinical trial information from Merck’s Fosamax program, the Advisory Committee members observed that there were no clinical trial data showing any long-term fracture reduction benefit from the use of the drug. The FDA Advisory Committee determined that these stronger long-term use warnings are necessary in light of the profound risks of osteonecrosis of the jaw (literally, death of the jaw) and non-traumatic femur fractures. Numerous epidemiologic studies have demonstrated a significantly increased risk of these side effects with long-term Fosamax use.
The FDA Advisory Committee immediately communicated to the FDA the results of its years-long research and analysis, as well as its 17 to 6 vote in favor of strengthening the Fosamax warnings and indications. The FDA, however, still has not brought to bear the necessary label change to the Fosamax prescriber’s information.
A likely reason for the unexplained delay? Merck and the FDA are negotiating a watered down label addition which would dilute the impact of the thorough analyses conducted by the FDA Advisory Committee showing that Fosamax’s beneficial effect wears off after a few years of use.
This “delay and dilute” plan is Merck’s modus operandi when dealing with the FDA and proposed label change. In January 2005, for instance, the FDA requested that Merck implement “class labeling” relating to the association of oral bisphosphonate drugs with osteonecrosis of the jaw. While every other oral bisphosphonate manufacturer implemented the FDA’s proposed class language concerning osteonecrosis of the jaw, throughout most of 2005, Merck fought the FDA and “negotiated” the label language such that the Fosamax label revision ultimately excluded reference to osteonecrosis of the jaw occurring in Fosamax patients.
More on Fosamax Femur Fractures.
Timothy M. O’Brien is a senior shareholder in the Levin, Papantonio law firm. He is national lead counsel for the Plaintiffs Steering Committee in MDL No. 1789, In re Fosamax Products Liability Litigation.