WASHINGTON WIRE
February 2, 2007
Issue 120
In this issue, you'll find:
House Approves FY 2007 Spending Bill, Senate to Consider Legislation
FDA Announces Initiatives to Improve Drug Safety Procedures
Senate Committee Passes Genetic Discrimination Legislation
PPSV in the News: Bobby Silverstein Joins PPSV
Hearings
Top Story
House Approves FY 2007 Spending Bill, Senate to Consider Legislation
As expected, the $463 billion overall spending bill for fiscal year (FY) 2007 sailed through the House on Wednesday despite objections from many House Republicans regarding the process. The measure now heads to the Senate for consideration.
Known as a continuing resolution (CR), the bill will fund government spending through September 30, 2007 – the end of the 2007 fiscal year. Prior to adjournment in December, the 109th Congress passed a previous CR or stop-gap spending measure through February 15th because agreement could not be achieved on nine of the eleven appropriations bill. The new CR bundles those remaining spending bills together.
Although the CR freezes most spending at FY 2006 levels, Congressional appropriators shifted approximately $10 billion to increase funding for some domestic programs. For example, the National Institutes of Health (NIH) would receive an additional $620 million in FY 2007. Similarly, Veteran Health would receive a $3.6 billion increase and the FDA would receive a $76 million increase from 2006 levels
The Senate is likely to take up the measure shortly and final passage could be delayed by amendments offered by members seeking increased funding for favored programs. However, with the President’s FY 2008 budget proposal scheduled to be released on Monday, lawmakers will be eager to put FY 2007 appropriations behind them and are likely to keep the pressure on for a relatively quick passage.
Health Care News
FDA Announces Initiatives to Improve Drug Safety Procedures
This week, the Food and Drug Administration (FDA) announced several changes, primarily to improve drug safety, to be implemented within the agency.
The announcements come in response to a comprehensive report released by the Institute of Medicine (IOM) last year which recommended an overhaul of the agency’s drug safety program. The FDA’s drug safety approval procedures originally came under fire in 2004 after a study found a popular arthritis drug, Vioxx, potentially increased the risk of heart attacks among users.
Among the initiatives outlined in the agency’s report is a new procedure to reassess the safety of drugs 18 months after their introduction on the market. The agency would also partner with the Department of Veteran Affairs in tracking and monitoring patients.
The FDA’s relatively flat budget has been stretched thin in recent years due to the increased responsibilities of preventing bioterrorism after the attacks of September 11. To finance its new changes, existing agency resources will be used in addition to funds received with the expected reauthorization of the Prescription Drug User Fee Act (PDUFA).
While the FDA did address many of the IOM’s suggestions, a number of recommendations, many of which would have required legislative action, were left out of the agency’s plan. Several members of Congress continue to support legislative strategies aimed at bolstering drug safety in addition to implementing the changes outlined in the FDA’s plan. This week Senators Dodd (D-CT) and Grassley (R-IA) and Senators Kennedy (D-MA) and Enzi (R-WY) introduced respective bills which focus on improving patient and drug safety.
The FDA's report can be found at http://www.fda.gov/oc/reports/iom013007.html.
Senate Committee Passes Genetic Discrimination Legislation
The Senate Health Education Labor and Pensions (HELP) Committee approved legislation to ban discrimination based on genetic information and the bill is now expected to pass the full Senate.
Introduced by Senator Olympia Snowe (R-ME), the bill would prevent employers from using an individual’s genetic information in determining employment, promotions, etc. Additionally, the legislation would ban health insurers from determining coverage, rates and premiums based on a person’s genetic information. Supporters state that the legislation is long-overdue and will help eliminate disincentives associated with genetic testing.
However, opponents of the legislation point out that many states have already implemented genetic discrimination bans and new federal requirements would only complicate matters for businesses and employers.
Nearly identical legislation has been passed in the Senate twice before, first in 2003 and then in 2005. Although the House has never considered genetic discrimination legislation, under the new Democratic Majority, it is likely that such legislation could be placed on the agenda this year. Jurisdictional issues could become a factor as the Education and Labor, Energy and Commerce, and Ways and Means Committees all have jurisdiction over the bill.
PPSV in the News: Bobby Silverstein Joins PPSV
Powers Pyles Sutter & Verville PC is pleased to announce the arrival of new partner Robert “Bobby” Silverstein. Mr. Silverstein joins Dick Verville, John Kemp, Peter Thomas and others in PPSV’s well-established disability, public policy and healthcare practice areas. His federal regulatory and legislative practice will also focus in the areas of rehabilitation, employment, education, social security, and civil rights.
In addition to his work at PPSV, Mr. Silverstein will continue as the director of the Center for the Study and Advancement of Disability Policy (www.disabilitypolicycenter.org). The Center conducts research and analysis of complex public policy issues affecting individuals with disabilities and their families. Prior to directing the Center, Mr. Silverstein was Staff Director and Chief Counsel for the US Senate Subcommittee on Disability Policy chaired by Senator Tom Harkin, who noted in the Congressional Record, “Bobby is truly among the best and brightest individuals in the field of public policy. In the field of disability policy, he has no equal.” (S. 9503, 9/17/97). Mr. Silverstein has over 30 years experience analyzing complex public policy issues and developing comprehensive and innovative legislative and regulatory solutions that meet the divergent needs of multiple stakeholders. He gained considerable experience negotiating and drafting bipartisan, consensus legislation. He was the behind-the-scenes architect of more than 20 bills enacted into law, including the landmark Americans with Disabilities Act.
Mr. Silverstein is the recipient of more than 10 national awards, including the Distinguished Services Award of the President of the United States. From 1997-2000, he served as an Associate Professor of Health Care Sciences, The George Washington University School of Medicine and Health Sciences. Mr. Silverstein earned his BS in Economics, cum laude, from the Wharton School, University of Pennsylvania (1971). He received his JD from Georgetown University Law Center (1974).
Powers Pyles Sutter & Verville PC is a Washington, DC-based law firm that focuses on health care, education, and the law of tax-exempt organizations. Mr. Silverstein can be reached at 202.466.6550 or bobby.silverstein@ppsv.com.
Upcoming Events
Hearings Fiscal 2008 Budget: Health and Human Services
Tuesday, February 6, 2007
House Energy and Commerce Committee
10 a.m., 2123 Rayburn Bldg.
Fiscal 2008 Budget Overview
House Ways and Means Committee
10 a.m., 1100 Longworth Bldg. (Feb. 7, 2 p.m. and Feb. 8, 10 a.m.)
Fiscal 2008 Budget Overview
Senate Finance Committee
2:45 p.m., 215 Dirksen Bldg. (Feb. 7, 10 a.m.)
Thursday, February 8, 2007
Special Diabetes Program for Indians
Senate Indian Affairs Committee
9:30 a.m., 485 Russell Bldg.
For More Information
For further information on any topics discussed or publications listed, or to get copies of anything mentioned in this alert, please call 202.466.6550 and ask for the Legislative Practice Group.
Powers Pyles Sutter & Verville PC is a full service law firm specializing in health care and education law and located at 1875 Eye St., NW 12th Floor, Washington DC 20006
© Copyright 2007, Powers Pyles Sutter & Verville PC.
All rights reserved.
