- The Washington Times - Thursday, May 31, 2007

A key Republican senator is pressing drug companies to cooperate with his investigation into the pricing and marketing of anemia drugs given to kidney patients.

After years of record profits assisted by federal payment polices, the drug companies Johnson & Johnson, which makes Procrit and Aranesp, and Amgen Inc., which makes the popular Epogen, could be facing darker days as a result of their marketing practices and pricing schemes.

Sen. Charles E. Grassley, Iowa Republican, announced this week his request that the drug companies brief his staff by June 13 on anemia drug pricing and marketing practices, as well as the overall safety of the kidney disease drugs.

“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,” said Mr. Grassley. “This troubles me because the FDA cannot do its job well if it lacks complete and accurate information.”

The drugs were approved because of their ability to lower the need for blood transfusions in cancer patients who have anemia because of chemotherapy. Medicare spending on the drugs is significant. In 2005, the program spent more than $770 million on the Procrit alone. Because these drugs are so costly, reining in their use, or overuse, should save money for a program like Medicare.

Reports on Medicare’s payment system creating incentives for administering higher doses than necessary and inordinate profits doctors are making through rebates they receive from purchasing the drugs directly from Amgen and Johnson & Johnson, are putting the spotlight on the issue.

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.”

Mr. Grassley, a longtime critic of the 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 Mr. Grassley in a May 16 letter to the 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. Mr. 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.”

Mr. Grassley is not the only one turning up the heat up on the drug companies. For its part, the FDA in March ordered Amgen and Johnson & Johnson to add black boxes to labels warning 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. And the Centers for Medicare and Medicaid Services proposed restricting reimbursement for anemia drugs to certain types of cancer.

In addition, just last month the Oncologic Drugs Advisory Committee, a committee that makes recommendations to the FDA, met to discuss the use of anemia drugs in cancer patients. The advisory committee recommended new restrictions on prescribing information and called for additional clinical trials to assess the drugs’ safety.

Health Care runs Fridays. Contact Gregory Lopes at 202/636-4892 or at glopes@washingtontimes.com.

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