Chuck is reacting to a spate of news reports last week that mostly centered on Amgen, which is already under a microscope for its marketing practices to doctors and its failure to report clinical trial data properly. Now, Grassley sent letters to the FDA, the drugmaker and the Centers for Medicare & Medicaid Services seeking all kinds of information.

He’s asked the FDA to identify any new tools it might need to gain access to necessary information from drug makers. And he wants Amgen to respond to allegations that it limited FDA access to the results of company studies and did not provide complete responses to the agency’s requests for data. And he wrote CMS asking for more info on how it monitors the administration of anemia meds.

This is an excerpt from one letter:

“Last Thursday, FDA’s Oncologic Drugs Advisory Committee met to discuss the use of erythropoiesis-stimulating agents (ESAs) in cancer patients. As you know, the Advisory Committee recommended new restrictions on prescribing information for ESAs and additional clinical trials to assess the drugs’ safety in light of reports of increased risk of cardiovascular disease, tumor growth, and even death associated with higher than recommended doses of the drugs…

I read with great concern the Los Angeles Times article, dated May 11, 2007, which noted that some members of the Advisory Committee suggested that Amgen Inc. (Amgen), manufacturer of the ESAs, Aranesp, Epogen and Procrit, the latter of which is marketed by Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson, “was not being upfront about all the drug’s risks.” What further troubled me was a Bloomberg article, also dated May 11, 2007, which reported that that the FDA was given limited access to results from company studies and Amgen did not provide complete responses to the FDA’s requests for data. This troubles me because the FDA cannot do its job well if it lacks complete and accurate information…

Several news articles have raised concerns not only about Medicare’s payment system creating incentives for using higher doses of ESAs than are necessary, but also the impact of marketing and supply contracts between ESA manufacturers and dialysis providers on the utilization of ESAs. The Wall Street Journal reported that Amgen Inc. (Amgen) may have promoted the use of Aranesp and Epogen for improving a patient’s quality of life without sufficient evidence for the claim. The New York Times reported on profits that doctors make through rebates they may receive from purchasing the drugs from Amgen and Johnson & Johnson and collecting payments from Medicare and private insurers, which are often above the purchase price.”

Further reading…
Grassley’s statement and letters.

[tags]Amgen, Aranesp, Chuck Grassley, Epogen, Johnson & Johnson, Procrit[/tags]