Grassley Seeks Additional Information About Pricing and Marketing of Anti-Anemia Drugs
Press Release
Sen. Chuck Grassley is asking a leading drug maker to cooperate with his ongoing inquiry into the pricing and marketing of anti-anemia drugs given to kidney and cancer patients and the Food and Drug Administration's access to data from the drug maker's studies of such drugs.
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May 30, 2007
Mr. William C. Weldon
Chairman and Chief Executive Officer
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, NJ 08933
Mr. Joaquin Duato
President
Ortho Biotech Products, L.P.
430 Route 22 East
P.O. Box 6914
Bridgewater, NJ 08807-0914
Dear Messrs. Weldon and Duato:
The United States Senate Committee on Finance (Committee) has jurisdiction over the Medicare and Medicaid programs. Accordingly, the Committee has a responsibility to the more than 80 million Americans who receive health care coverage under those programs to oversee the proper administration of the programs and ensure that beneficiaries receive drugs that are both
safe and effective.
On May 10, 2007, the Food and Drug Administration's (FDA) Oncologic Drugs
Advisory Committee (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 addition, on May 14, 2007, the Centers for Medicare and Medicaid Services (CMS)
released its proposed coverage decision memorandum regarding the clinical conditions for Medicare reimbursement for ESAs. In 2005, Medicare alone spent more than $770 million on the anti-anemia drug Procrit marketed by Johnson & Johnson's subsidiary Ortho Biotech Products, L.P. (Ortho Biotech).
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.[1] In particular, The New York Times reported on profits that doctors can
make through rebates they receive from purchasing the drugs directly from Amgen Inc. and Johnson & Johnson and collecting payments from Medicare and private insurers, which are often above the purchase price. In addition, it is my understanding that the rebates are based on the amount of drugs purchasedthe more a doctor buys, the higher the rebate.
I also read with great concern The Wall Street Journal article dated May 10, 2007, regarding allegations by two former Ortho Biotech salesmen that the company engaged in questionable pricing practices and "pushed" doctors to prescribe a higher dose of Procrit before FDA had approved that dose for cancer patients. Overuse of ESAs is not only a financial concern to the Committee, but also a major patient safety concern because recent clinical studies identified increased risks of death, blood clots, strokes, heart attacks, and tumor growths when ESAs are given in higher than recommended doses.
In addition, I was troubled by a Bloomberg article, dated May 11, 2007, which reported that the FDA was given limited access to results from company studies.[2] Although the article did not discuss the details of this so-called "limited" access, I believe it is essential that the FDA receive complete and accurate information in order for the agency to take appropriate and timely
actions in response to emerging safety concerns.
Accordingly, I am requesting that Johnson & Johnson and Ortho Biotech cooperate with the Committee's review of the marketing and pricing allegations reported in The Wall Street Journal on May 10, 2007. In addition, I request that Johnson & Johnson and Ortho Biotech arrange a briefing for my Committee staff by June 13, 2007, to discuss the issues and concerns
that have been reported in the media over the last several weeks regarding, among other things, Johnson & Johnson's and/or Ortho Biotech's pricing and marketing practices and the safety of ESAs. In particular, please be prepared, at a minimum, to address the following questions at the briefing:
[1] Marilyn Chase, "Amgen's Star Fades Amid Safety Questions," The Wall Street Journal, April 10, 2007; "Dialysis Profits May Put Patients At Risk," Associated Press, April 19, 2007; Alex Berenson and Andrew Pollack, "Doctors
Reap Millions for Anemia Drugs," The New York Times, May 9, 2007; Heather Won Tesoriero and Avery Johnson, "Suit Details How J&J Pushed Sales of Procrit," The Wall Street Journal, May 10, 2007.
[2] Luke Timmerman, "Amgen Shares Fall on Downgrades, Anemia Drug Concern," Bloomberg, May 11, 2007.
1. As mentioned in this letter, Bloomberg reported that FDA was given limited access to results from company studies. Did Johnson & Johnson and/or Ortho Biotech limit FDA's access to any study results? If so, please explain why complete results were withheld from the FDA and identify the studies from which the results were withheld. In addition, did Johnson & Johnson and/or Ortho Biotech withhold any other information or data requested by the FDA related to the safety and/or efficacy of ESAs?
2. Please identify all safety and efficacy trials of ESAs sponsored either directly or indirectly by Johnson & Johnson and/or Ortho Biotech whether conducted within or outside the U.S. from January 2002 through May 2007 in a table according to the following format. If Johnson & Johnson and/or Ortho Biotech have in their possession information from post-marketing studies or clinical trials conducted by independent investigators, please also include that information in the table.
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3. In its proposed coverage decision memorandum,[3] CMS expressed concern that a number of clinical trials of ESA treatment have been terminated, suspended, and/or otherwise not completed. Did Johnson & Johnson and/or Ortho Biotech sponsor any trials of ESA treatment from January 2002 through May 2007 that were terminated, suspended, and/or
otherwise not completed that showed evidence of serious adverse effects? If so, have the results from those trials been made available to the FDA? If not, please explain why those trial results were withheld from the FDA and identify the trials from which the results were withheld. Please provide information regarding the trials in a table according to the following format:
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[3] Available on the CMS Web site at http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=203.
4. The Wall Street Journal reported on May 10, 2007, that Johnson & Johnson "urged" doctors to enroll patients in "mini" trials using a once-a-week 40,000-unit dose instead of three 10,000-unit doses a week. What were the findings of those trials? Did Johnson & Johnson and/or Ortho Biotech submit any reports and data to the FDA related to these "mini" trials? Please provide the Committee with a copy of any reports prepared by Johnson & Johnson and/or Ortho Biotech and/or any of the companies' consultants, including third party contractors regarding the findings and conclusions of these so-called "mini" trials, in particular findings related to the safety of Procrit.
5. Please provide the total and average amounts and range of rebate payments to physicians and group practices that purchased Procrit from Johnson & Johnson and/or Ortho Biotech in calendar years 2004, 2005, and 2006 by state. How many physicians and group practices in each state received rebates from Johnson & Johnson and/or Ortho Biotech for
Procrit in calendar years 2004, 2005, and 2006? As a preliminary response to this request, please identify the five physicians and/or group practices that received the highest rebate payments in each state in calendar years 2004, 2005, and 2006.
6. In light of the reported increased risk of serious adverse effects, including death, associated with the use of ESAs in cancer patients no longer on chemotherapy, what actions, if any, have Johnson & Johnson and/or Ortho Biotech taken to ensure that doctors and patients are informed of the new safety risks? Please provide a detailed timeline of Johnson & Johnson's and/or Ortho Biotech's actions regarding Procrit beginning with the date on which the company first became aware of potential, increased risks related to the use and/or overuse of ESAs in cancer patients.
Any documents responsive to the issues and questions to be discussed at the briefing should be sent prior to the briefing via electronic transmission in PDF searchable format to thomas_novelli@finance-rep.senate.gov or via facsimile to (202) 228-2131 and original by U.S. mail in accordance with the attached instructions and general definitions. In cooperating with
the Committee's review, no documents, records, data or information related to these matters shall be destroyed, modified, removed or otherwise made inaccessible to the Committee.
I look forward to your cooperation and assistance on this important matter.
Thank you in advance for providing the name and contact information, including an e-mail address, for a person who will act as the point of contact for Johnson & Johnson/Ortho Biotech during the Committee's review by no later than June 4, 2007.
Sincerely,
Charles E. Grassley
Ranking Member
Committee on Finance
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