Harsh criticism lobbed at FDA in Senate Vioxx hearing

Janis Kelly

| November 23, 2004
 

Nov 23, 2004

Washington, DC - The November 18, 2004 hearing of the powerful US Senate Finance Committee produced harsh criticism of the role of the US Food and Drug Administration (FDA) in the rofecoxib (Vioxx, Merck) debacle and likely accelerated Congressional pressure for creation of a drug safety division with independent authority to act on safety concerns about FDA-approved drugs.

Controversial FDA scientist Dr David Graham stunned the hearing when he warned that 5 drugs currently on the US market (among them valdecoxib [Bextra, Pfizer] might pose significant risks and should be reconsidered (see sidebar at end of article).


FDA safety system described as "broken"

Witnesses and Senate Finance Committee members charged that the FDA's Office of New Drugs:

  • Rushed Vioxx through the new drug approval process with unnecessary haste and in the face of concerns about cardiovascular risk raised by the agency's own reviewers.

  • Missed or ignored "red-flag" safety warnings after the drug was on the market and tried to silence an agency scientist whose analysis raised additional concerns about the drug.

  • Delayed too long in adding a cardiovascular warning to the rofecoxib label and allowed Merck too much control over what the label would say.

  • Is generally reluctant to act on safety problems that might cast doubt on previous regulatory decisions.

The hearing contributed to a perception that the FDA is an agency in trouble. The Bush Administration has not appointed anyone to replace former FDA director Mark McClellan, who left in 2002 to head the Centers for Medicare and Medicaid Services (CMS), and there has been no director of the Office of Drug Safety for nearly 2 years. The Center for Drug Evaluation and Research (CDER) likewise has only an acting director.

The Senate Finance Committee is involved because it oversees the budgets for Medicaid (which helps provide healthcare for the poor and disabled) and for Medicare (which helps provide healthcare for the elderly). Together the programs cover more than 80 million Americans, and committee chair Sen Charles Grassley (R-IA) stated that Medicaid paid more than $1 billion for Vioxx during the time the drug was available in the US.

Vioxx is a terrible tragedy and a profound regulatory failure. . . . The FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.

Star witness and a major source for committee investigators was Graham, associate director for science and medicine in the FDA's Office of Drug Safety. Graham described the FDA and its CDER as "broken" and said, "Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless."

Grassley charged that the FDA, among other failings, permitted Merck to delay for 14 months before adding information about cardiovascular risk to the Vioxx labeling, during which time the company "aggressively marketed Vioxx, knowing that consumers and doctors were largely unaware of the cardiovascular risks." This delay, like the apparent discounting of bad news from the FDA's own researchers, mirrors problems the Finance Committee had already investigated with regard to the increased suicide risk associated with use of some antidepressants in children and adolescents. Continue Reading

 
 
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Author(s)

Janis Kelly

Janis Kelly is a freelance writer for Medscape. She has been a medical journalist since 1976, with extensive work in rheumatology, immunology, neurology, sports medicine, AIDS and infectious diseases, oncology, and respiratory medicine.

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