Patent Reform Remains Top CHI Priority on Capitol Hill
Today, CHI joined over 200 companies, associations, venture capitalists and academic research institutions from across the country on a letter to key lawmakers regarding patent legislation in the House and Senate.  The broad coalition is concerned that certain provisions contained in H.R. 1908 / S. 1145, the Patent Reform Act of 2007, will weaken the quality of patents, hindering innovative new discoveries across a wide spectrum of the American economy.  Specifically, provisions addressing apportionment of damages, expansive PTO rule-making authority, and a post-grant review “second window” threaten to reduce patent certainty, weaken protections against patent infringement, and undermine intellectual property protection of biomedical investment and innovation.  Legislative activity continues on Thursday, June 21, when the Senate Judiciary Committee is scheduled to mark up legislation.  The House Judiciary Subcommittee marked up its version of the bill on May 18 and a full committee mark is expected in the near future.  CHI continues to work with members of the California congressional delegation to outline our industry’s concerns about the current draft.  For more information, contact Todd Gillenwater, CHI vice president-public policy (858-551-6677 or gillenwater@chi.org).

House Committee Focuses on FDA Legislation
The House Energy and Commerce Health Subcommittee will mark up nine draft legislative proposals today that reauthorize programs at the Food and Drug Administrations (FDA) while implementing new drug safety requirements.  CHI is concerned that certain proposed provisions in the bill could impede the medical device and biopharmaceutical industries’ ability to develop innovative medical technologies.  Specifically:

• A possible preemption amendment that would grant states the opportunity to enact different standards and requirements for product liability cases.
• The legislation does not include changes negotiated in the Senate that streamline the third-party inspection program, making it more workable.
• A possible amendment that would require a unique device identifier on every implant and a requirement for manufacturers to set up a patient registry for every implantable device.
• A provision to require pediatric device post-market surveillance studies as a condition of approval.  Adult or generally labeled devices could not be distributed until an agreement is reached.
• Requirements that could compromise important proprietary information by requiring posting of clinical trial information prior to clearance or approval by the FDA.
• Limited conflict of interest waivers for FDA advisory panels that could severely limit the already narrow expertise available.
• An increase in user fees over and above the agreement that was negotiated between industry and the FDA.

Follow-on Biologics Draft Expected This Week
Lawmakers in the Senate continue to hold discussions into this week in an attempt to reconcile differences on legislation that would create a regulatory pathway for the approval of “follow-on” versions of biological products.  The so-called Group of Four, Senators Edward Kennedy (D-MA), Hillary Clinton (D-NY), Michael Enzi (R-WY) and Orin Hatch (R-UT), hope to have draft legislation available later on this week in preparation of a Health, Education, Labor and Pensions Committee mark-up now scheduled for next Wednesday, June 27.  CHI continues to work with members of Congress to encourage an approach to follow-on products that includes appropriate incentives for the creators of innovative first-in-line medical products, measures to ensure patient safety and reasonable intellectual property protection.

NIH Appropriations Process Moves Forward in House and Senate
After the NIH budget doubled, recent budget tightening in Washington has led to four years of constrained resources for the NIH.  This trend continued on Thursday, June 7, at a mark-up of the House Labor, HHS, Education and Related Agencies Appropriations Subcommittee.  The committee passed legislation allocating a 2.6% increase for the agency (below the rate of inflation), a decision that is sure to deprive important new research projects of support, discouraging young scientists from pursuing research careers.  Action now moves to the Senate where CHI and other proponents of increased science funding are more optimistic.  Chairman Tom Harkin (D-IA) and Ranking Member Arlen Specter (R-PA) have historically been champions of biomedical research and have in recent weeks reaffirmed their commitment to the NIH.  A mark-up for that subcommittee has been scheduled for today.  CHI continues to weigh in with members of Congress to highlight the importance of biomedical innovation.

House Panel Holds Hearing on Comparative Effectiveness
As health care costs continue to escalate, policymakers in Washington are calling for assessments of the relative effectiveness of health care services with the goal of assuring high-quality care while reducing unnecessary spending.  On Tuesday, June 12, the House Ways and Means Health Subcommittee addressed this issue in a hearing on strategies to improve information on comparative clinical effectiveness.  Business interests, consumer advocates and federal officials urged Congress to begin work on the expansion of clinical effectiveness information for drugs and devices.  While CHI supports the development of medical evidence, we are concerned that proposals may have unintended consequences on the introduction of new innovative technologies and that data may be used to dictate coverage decisions, potentially limiting patient access to certain treatments.  For more information, contact Todd Gillenwater, CHI vice president-public policy (858-551-6677 or gillenwater@chi.org).

Upcoming Hearings and Events

June 19 – 10:00 a.m. (EST)
House Energy and Commerce Committee
Health Subcommittee markup of FDA Health Legislation.
2123 Rayburn House Office Building
Link

June 19 – 4:00 p.m. (EST)
Senate Appropriations Committee
Labor, Health and Human Services, Education, and Related Agencies Subcommittee markup of FY2008 appropriations.
124 Dirksen Senate Office Building
Link

June 21 – 10:00 a.m. (EST)
Senate Budget Committee
Full committee hearing on "Health Care and the Budget: Issues and Challenges for Reform."
608 Dirksen Senate Office Building
Link

June 21 – 10:00 a.m. (EST)
Senate Judiciary Committee
Full committee markup of S.1145, the "Patent Reform Act of 2007."
226 Dirksen Senate Office Building
Link

June 21 – 2:00 p.m. (EST)
Senate Appropriations Committee
Full committee markup of the FY2008 Labor, HHS, Education and Related Agencies Appropriations bill.
106 Dirksen Senate Office Building
Link

June 21 – 2:00 p.m. (EST)
House Ways and Means Committee
Health Subcommittee hearing on "Protecting Beneficiaries in Medicare Part D Plans."
1100 Longworth House Office Building
Link

June 22 – 10:00 a.m. (EST)
Senate Appropriations Committee
Labor, HHS, Education and Related Agencies Subcommittee hearing on a new vision for medical research relating to FY2008 budget for the National Institutes of Health.
116 Dirksen Senate Office Building
Link