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 drugs, "The Washington Times" reported June 1.

"What troubles me is a Bloomberg article, which reported 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," 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 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," according to 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 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 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 has also proposed restricting reimbursement for anemia drugs to certain types of cancer.