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Internal FDA Documents Show Career Staff Objected to Agency’s New Stance on Preemption

According to a report released today by Chairman Waxman, key FDA career officials strongly objected to Bush Administration drug labeling regulations that would preempt state liability lawsuits, asserting that the central justifications for the regulations were “false and misleading” and warning that the changes would deprive consumers of timely information about drug hazards.

Proposed Regulation Blocking Access to Healthcare Violates Executive Order

Chairman Waxman requested an explanation from HHS Secretary Leavitt on why a proposed rule that would threaten access to reproductive and other health services was issued in apparent violation of an executive order requiring interagency coordination and review.

Chairman Waxman Requests Information on Health Insurance Recissions

As part of the Committee’s ongoing investigation, Chairman Waxman wrote to several insurance companies and each of the state insurance commissioners seeking information about the practice of companies retroactively cancelling individual health insurance policies after policyholders submit expensive claims.

Survey of State Hospital Associations: Practices to Prevent Hospital-Associated Bloodstream Infections

Chairman Waxman and Ranking Member Davis issued a report on hospital-associated infections. This report summarizes the results of a staff survey of state hospital associations which shows that the majority of state hospital associations have not adopted a program which could save thousands of lives and billions of dollars.

Chairman Waxman Questions FDA Priorities

Chairman Waxman wrote to FDA Commissioner von Eschenbach to request answers to questions raised by internal FDA emails, which suggest that political appointees at the agency may be promoting industry priorities at the expense of FDA’s core public health mission.

Committee Holds Hearing on Domestic HIV Epidemic

The Committee held a hearing titled, “The Domestic Epidemic is Worse than We Thought: A Wake-Up Call for HIV Prevention” on Tuesday, September 16, 2008, in 2154 Rayburn House Office Building.

Committee to Hold Hearing on HIV/AIDS

The Committee will hold a hearing in September to consider the implications of new HIV incidence numbers announced by the Centers for Disease Control.

Chairman Waxman Delivers Democratic Radio Address

On August 2, 2008, Chairman Waxman delivered the Democratic Radio Address. In his address, Chairman Waxman discussed critical legislation passed by the House this week that addresses the health and safety of America’s children.

Chairman Waxman's Statement on the New CDC HIV Incidence Numbers

Chairman Henry A. Waxman released the following statement today upon the release of new Centers for Disease Control (CDC) HIV incidence numbers.

Committee Holds Hearing on Terminations of Individual Health Insurance Policies

The Committee on Oversight and Government Reform is holding a hearing titled, “Business Practices in the Individual Health Insurance Market: Terminations of Coverage” on Thursday, July 17, 2008, in 2154 Rayburn House Office Building.

Chairman Waxman Questions Proposed Rule Regarding Automobile Roof Safety

In a letter to Department of Transportation Secretary Peters, Chairman Waxman questioned a proposed rule by the National Highway Traffic Safety Administration that fails to ensure that automobile roofs are strong enough to protect passengers in rollover crashes. Chairman Waxman urged the Secretary to issue a strong rule that will significantly reduce the number of deaths and injuries caused by the crushing of vehicle roofs during rollovers.

Investigation Continues into Whether FDA Regulation Should Bar Liability Claims

Following a May 14, 2008, hearing, Chairman Waxman wrote to the FDA to request documents related to the agency’s recent reversal of its long-standing position on preemption of state product liability lawsuits relating to FDA-approved drugs and medical devices.

Committee Holds Hearing on Whether FDA Regulation Should Bar Liability Claims

The Committee on Oversight and Government Reform held a hearing titled, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” on Wednesday, May 14, 2008, in 2154 Rayburn House Office Building.

Committee Surveys State Hospital Associations Regarding Healthcare Associated Infections

Chairman Waxman sent letters to each of the nation’s state hospital associations requesting information about their efforts to halt the epidemic of healthcare associated infections and whether proven solutions have been implemented.

Committee Holds Hearing Assessing the Evidence of Domestic Abstinence-Only Programs

The Committee held a hearing titled, “Domestic Abstinence-Only Programs: Assessing the Evidence” on Wednesday, April 23, 2008, in 2154 Rayburn House Office Building.

Healthcare-Associated Infections: A Preventable Epidemic

The Committee held a hearing titled, “Healthcare-Associated Infections: A Preventable Epidemic” at 11:00 a.m., on Wednesday, April 16, 2008, in 2154 Rayburn House Office Building.

Democrats Urge Trade Ambassador to Focus on Access to Medicines

In a letter to U.S. Trade Representative Schwab, Chairman Waxman and twenty-six other Members of Congress asked that in reviewing the global state of intellectual property rights the Ambassador act upon the United States’ commitment to respecting measures that improve access to live-saving medicines in developing countries.

Chairman Waxman Statement on EPA’s Final Rule on Lead Renovation, Repair, and Painting

Chairman Henry A. Waxman released the following statement in response to EPA’s issuance of a final rule on lead renovation, repair, and painting.

Members Urge Office of National Drug Control Policy to Support Needle Exchange Programs

In a letter to the Office of National Drug Control Policy, Chairman Waxman and Rep. Barbara Lee responded to Director John Walter’s unsupported assertion that needle exchange programs “support” injection drug use. The letter cites numerous studies that found needle exchange programs help reduce the spread of HIV and other dangerous infectious diseases without encouraging or increasing drug use, and in fact provide opportunities to reduce illegal drug use.

Committee Holds Hearing on Myths and Facts about Human Growth Hormone, B12, and Other Substances

The full Committee held a hearing at 10:00 a.m. to examine the myths and facts about performance-enhancing substances such as human growth hormone, B12 and other substances.

Members Call on the Science Board to Assess Resources Needed to Remedy FDA's Funding Crisis

Reps. Henry A. Waxman, John D. Dingell, Bart Stupak, and Frank Pallone, Jr., called on members of one of FDA’s own advisory committees to provide Congress with its assessment of the resources needed to remedy the crisis at the agency stemming from years of chronic underfunding.

Chairman Waxman Requests Briefing on Inspections of Chinese Drug Manufacturer

In a letter to FDA Commissioner von Eschenbach, Chairman Waxman requested a briefing on FDA inspections of all facilities owned by the Shanghai Pharmaceutical Group that produce drugs for the United States. The Chinese company is currently under criminal investigation in China for the production of tainted leukemia drugs and manufactures at least one drug for export to the United States.

Full Committee Holds Hearing on CDC Program Providing Breast and Cervical Cancer Screening

The full Committee held a hearing on “Addressing the Screening Gap: The National Breast and Cervical Cancer Early Detection Program.” The hearing examined the National Breast and Cervical Cancer program which is administered by the Centers for Disease Control and Prevention (CDC) to provide mammograms, pap smears, and other screening exams for breast and cervical cancer to low-income women without another source of coverage.

Members of Congress Question FDA Proposal Designed to Create Liability Shield for Drug and Device Companies

Today Representatives Henry A. Waxman, John D. Dingell, Frank Pallone, Jr., Rosa L. DeLauro, and Edward Markey, and Senators Edward M. Kennedy, Patrick J. Leahy, and Christopher J. Dodd, questioned the basis for a new Food and Drug Administration (FDA) proposal that was apparently designed to shield pharmaceutical and device companies from liability for injuries sustained by American consumers as a result of unsafe products.

Chairman Waxman Requests FDA Provide Documents Regarding Drug Company Marketing Loophole

On January 22, Chairman Waxman wrote to FDA Commissioner von Eschenbach requesting documents related to the FDA’s draft guidance allowing drug companies to use journal articles to promote potentially dangerous off-label uses of drugs and medical devices without prior FDA review and approval. According to FDA minutes of a meeting, Dan Troy and other drug company representatives urged FDA to issue guidance to protect the companies from “Federal prosecutors pursuing distributors of this information for criminal conduct.”

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