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© 2002 AlphaMed Press
NEWS AND SPECIAL REPORT |
Capitol Report
Senior Director, Pharmacia Corporation Marguerite.D.Baxter{at}pharmacia.com
QUALITY CANCER CARE ON THE CONGRESSIONAL AGENDA
Several legislative proposals have been introduced in the U.S. Senate that address quality cancer care. Senators Edward M. Kennedy (D-MA) and Bill Frist (R-TN) introduced a bipartisan proposal, S. 2965, the Quality of Care for Individuals with Cancer, on September 18th. The bill authorizes a number of federal grant programs designed to improve the quality of cancer care and the development of a core set of quality cancer measures. The programs created under these grants would use the measures to gather data on oncology providers and influence the training of providers. Specifically, the outcomes of the grant programs would be to develop, implement, and evaluate cancer case management programs and improve navigation through the cancer care delivery system. In addition, two programs focus on the development of model systems for the delivery of quality palliative care and end-of-life care. On September 25th, Senators Brownback (R-KS) and Gregg (R-NH) introduced the National Cancer Act of 2002, a bill that directs the Secretary of Health and Human Services (HHS) to develop a strategy to link data from the state cancer registries and the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute (NCI).
The bills were referred to the Senate Health, Education, Labor, and Pensions Committee for consideration. No hearings have been scheduled.
FOOD AND DRUG ADMINISTRATION (FDA) TO CONSOLIDATE DRUG REVIEWS
The FDA has announced a plan to consolidate oversight of pharmaceuticals, including therapeutic biologics, under the aegis of the Center for Drug Evaluation and Research (CDER). Heretofore, therapeutic biologics were regulated separately under the Center for Biologic Evaluation and Research (CBER). It is expected that the regulatory process for biologies will continue to be a biologics license application (BLA). CDER traditionally has reviewed its products by New Drug Applications, or NDA’s as they are commonly known. Dr. Murray Lumpkin is heading an integration committee to look at the myriad of issues that the agency will be facing by combining the review function under CDER. While many applaud the action as one that will provide predictability to the review process of biologics, critics assert that it will slow the review process overall. This is likely to be monitored closely as a result of the enactment of the Prescription Drug User Fee Act (PDUFA) this past spring, legislation that statutorily establishes review times for drugs and biologics within the agency.
CENTERS FOR MEDICARE AND MEDICAID PROPOSE A FINAL RULE FOR HOSPITAL OUTPATIENT SERVICES
On August 9, 2002 the Centers for Medicare and Medicaid Services (CMS) proposed a final rule updating the Hospital Outpatient Prospective Payment System. Based upon an analysis of 2001 claims data, the Agency has estimated that the cost per unit of a sole source drug is on average 71% of the average wholesale price (AWP), which translates to a "spread" of about 40% between the published AWP and the actual acquisition cost for pharmaceuticals. Thus, they have calculated reduced payment rates for products administered in hospital outpatient settings. The revised payment rate is far below the current level of 86% of AWP under the transition period that CMS established last year.
Under the new rule, Medicare outpatient payments overall will rise at a rate of 3.5% and reimbursement for high-tech devices and drugs will change dramatically. In particular, oncology drugs that have enjoyed a "pass through" payment rate for the past 2.5 years, exempting them from being assigned ambulatory payment classifications (or APCs), will now be reimbursed at rates well below those assigned during the "pass through" transition period. Now that the drugs will be allocated into APCs the overall CMS objective of budget neutrality for all outpatient hospital services will be achieved. That said, several patient groups and trade associations of the pharmaceutical and device industries are working with Congress in an attempt to delay the transition to the APC classifications until additional data can be collected and provided to CMS.
TOBACCO LEGISLATION INTRODUCED IN THE U.S. SENATE
Senators Edward M. Kennedy (D-MA) and Mike DeWine (R-OH) have introduced S. 2626, the Youth Smoking Prevention and Public Health Protection Act, legislation to regulate tobacco products under a new chapter of the Food, Drug, and Cosmetic Act. The legislation sets forth criteria by which tobacco products will be deemed adulterated and/or misbranded. It authorizes the Secretary to adopt performance standards and provides for notification and other remedial measures, and post marketing surveillance. It requires manufacturers and importers to keep records and requires coordination with the Federal Trade Commission to enforce certain laws concerning the advertising, sale, or distribution of tobacco products. No hearings are scheduled prior to the adjournment of Congress.
SENATE PASSES LEGISLATION AFFECTING PATENT PROTECTION FOR NEW DRUGS AND BIOLOGICS
In August the U.S. Senate passed S. 812, the Greater Access to Affordable Pharmaceuticals Act of 2001, commonly known as McCain-Schumer. The intent of the authors of the legislation was to eliminate loopholes in the 1984 Hatch-Waxman law that allows innovator companies to delay generic drugs from entering the market. That said, many critics believe that the legislation falls far short of closing loopholes and is merely an ill-conceived attempt to further diminish the patent protections afforded innovator companies. Despite several attempts by the Democratic leadership to amend the underlying bill with Medicare reform and prescription drug access provisions, the Senate failed to include meaningful provisions that would truly provide greater access to affordable pharmaceuticals.
The passed legislation included provisions that would codify 15 pages of FDA regulation on generic bioequivalence, a 45-day statute of limitations for pioneer drug makers to litigate against a generic entering the market, and a private right of action for generics to sue to de-list patents from the FDA Orange Book. The legislation also includes an amendment offered by Senator Byron Dorgan (D-ND) that would allow pharmacies and pharmacy benefit managers (PBM) to reimport American-made, FDA-approved prescription drugs into the U.S. from Canada. However, the amendment was altered by a second-degree amendment offered by Senator Mitch McConnell (R-KY) that allows the HHS secretary to discontinue reimportation if it is deemed unsafe for the public.
PEOPLE AND PLACES...
New NIH Senior Advisor:
Ruth Kirschstein, M.D., National Institutes of Health (NIH) Deputy Director, has announced that she will be stepping down when a successor is selected. Dr. Kirschstein, who served as the Acting Director, NIH, until Dr. Elias Zerhouni was appointed on May 20, 2002, will transition to a role as senior advisor to the NIH Director. Dr. Kirschstein joined the NIH in 1957. In tribute to her long years of public service the FY 2002 Supplemental Appropriations bill designated that the NIH National Research Service Award be renamed the Ruth L. Kirschstein National Research Service Award. Through these awards, the NIH supports over 16,000 doctoral students and post-doctoral fellows.
WHITE HOUSE ANNOUNCES FDA COMMISSIONER NOMINEE
The White House has announced Mark McClellan, M.D., Ph.D. as their nominee for the Commissioner, FDA. It has been 23 months since Commissioner Jane Henney, M.D. was asked to step down by the Bush Administration, the longest period that the agency has ever gone without a Commissioner. Dr. McClellan is currently a member of the President’s Council on Economic Advisors, and he also serves as a senior policy director for health care and related economic issues for the White House. He was confirmed as a Member of the Council of Economic Advisers (CEA) by the Senate on July 19, 2001, so it is expected that a confirmation process in the Senate will be possible prior to the adjournment of the 106th Congress this fall. Before joining the CEA, he was Associate Professor of Economics at Stanford University, Associate Professor of Medicine at Stanford Medical School, a practicing internist, and Director of the Program on Health Outcomes Research at Stanford University. He was also a Research Associate at the National Bureau of Economic Research and a Visiting Scholar at the American Enterprise Institute. Additionally, he was a Member of the National Cancer Policy Board of the National Academy of Sciences.
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