Grassley presses EPO makers on safety, pricing and marketing.Sen. Charles E. Grassley (R-IA) has requested that Johnson & Johnson, which makes Procrit and Aranesp, and Amgen, which makes Epogen, brief his staff on anemia drug pricing and marketing practices, as well as the overall safety of the kidney disease Kidney Disease Definition
Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. drugs, "The Washington Times" reported June 1.
"What troubles me is a Bloomberg article, which reported that the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. was given limited access to results from company studies and Amgen did not provide complete responses to the FDA's requests for data," Grassley told the Times. "This troubles me because the FDA cannot do its job well if it lacks complete and accurate information."
In May, Sen. Grassley introduced Amendment No. 996 to the FDA Revitalization re·vi·tal·ize
tr.v. re·vi·tal·ized, re·vi·tal·iz·ing, re·vi·tal·iz·es
To impart new life or vigor to: plans to revitalize inner-city neighborhoods; tried to revitalize a flagging economy. Act, which "provides for a certification that all clinical trial information related to the safety and efficacy of a drug under review is submitted to the Food and Drug Administration as part of a new drug or supplemental application A Supplemental Application Is A Type Of Application Used By universities and Colleges From the State University Of New York(SUNY). The Supplemental Application is A common 2nd part of The 1st State-wide Application. ," according to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. the senator's statement. "This is intended to have drug sponsors affirmatively state that they submitted all the information that they are expected to submit."
The drugs, which reduce the need for blood transfusions blood transfusion, transfer of blood from one person to another, or from one animal to another of the same species. Transfusions are performed to replace a substantial loss of blood and as supportive treatment in certain diseases and blood disorders. in cancer patients who have anemia because of chemotherapy, have become extremely popular. In 2005, The Times reported, the Medicare program spent more than $770 million on Procrit alone.
The Times stated that the use of EPOs is coming under increasing scrutiny due in part to reports that charge that the Medicare payment Noun 1. medicare payment - a check reimbursing an aged person for the expenses of health care
bank check, check, cheque - a written order directing a bank to pay money; "he paid all his bills by check" system creates incentives for administering higher doses than necessary, and that doctors are making inordinate profits through rebates they receive by purchasing the drugs directly from Amgen and Johnson & Johnson.
According to "Science Daily", as many as 450,000 patients in the U.S. are currently receiving anemia medications, which can cost $1,000 per treatment.
Grassley, a longtime critic of FDA's drug-safety efforts, may seek to force the agency to more effectively regulate these drugs.
"It appears that the FDA may need tools that will enable the agency to obtain access to additional data and information from manufacturers so informed decisions can be made about a drug's safety and efficacy," said Grassley in a May 16 letter to FDA Commissioner Andrew von Eschenbach.
The Senate has already passed the FDA reauthorization bill, which would enact new drug-safety mechanisms within the agency, but it does not include any specific language on anemia drugs. Grassley says the House bill, which has yet to be introduced, could consider measures "to strengthen the hand of the FDA in looking out for American consumers."
Grassley is not the only one turning up the heat up on the drug companies, The Times reported. FDA in March ordered Amgen and Johnson & Johnson to add black-box warnings to the drugs' labels about an increased risk of numerous adverse events and issued a public health advisory warning health care providers to administer the lowest possible dosage necessary to treat anemia. The Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and has also proposed restricting reimbursement Reimbursement
Payment made to someone for out-of-pocket expenses has incurred. for anemia drugs to certain types of cancer.