Senate bill tackles drug safety, reauthorizes user fee act

Measure also provides the Food and Drug Administration with the clout to require postmarketing studies and label changes.

By Susan J. Landers — Posted June 4, 2007

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With an eye toward avoiding future drug safety flaps, the Senate May 9 passed a bill that, among other things, would require the Food and Drug Administration to monitor drugs more closely after they reach the market.

The provision is intended to hasten the detection of adverse events among newly approved medications. It is one of several drug safety measures included in legislation reauthorizing a program under which drug firms pay the FDA millions of dollars each year for faster review of their products.

When Vioxx (rofecoxib) was withdrawn from the market in 2004, it already had been sold for about five years and used by millions of patients for pain relief before its harmful cardiovascular effects surfaced.

The reputation of the FDA as the watchdog over the nation's drugs was damaged by this controversy and other safety concerns such as risks posed by certain antidepressants. Such events resulted in the agency working with manufacturers to place heightened warning labels on several drugs. But this action happened long after the medicines had been approved and were widely available.

An Institute of Medicine report last fall also pointed to the need for ongoing scrutiny of approved drugs.

"The FDA should be the gold standard for safety, but its luster has been tarnished in recent years by failure to protect the American people from unsafe drugs," said Sen. Edward Kennedy (D, Mass.), chair of the Senate Health, Education, Labor and Pensions Committee. Kennedy drafted the bill with the committee's ranking member, Sen. Mike Enzi (R, Wyo.). It was passed by a 93-1 vote. Sen. Bernie Sanders (I, Vt.) cast the lone negative vote to protest the addition of an amendment that gutted a provision allowing drugs to be imported from other countries.

The American Medical Association viewed the measure as a sign of progress. "[It's a] step in the right direction toward better patient safety," said AMA board Chair Cecil B. Wilson, MD. "Doctors need regular access to updated drug risk-benefit information to ensure they can provide the best treatments for their patients."

Among its safety measures, the Senate bill requires the FDA to establish a surveillance system within two years of the measure's enactment. The system would allow the agency to collect and report information on adverse reactions gathered from patient records and physician reports by mining data collected by Medicare, the Veterans Administration health system, pharmaceutical purchasing programs and private health insurers.

The agency had undertaken the development of a sentinel system last year to help with the detection of drug problems, but no time frame existed for its completion, and the agency's dearth of funds for the project also stood in the way of its completion. The Senate bill would provide $25 million per year for five years to fund the surveillance system.

The amendment calling for the surveillance system was offered by Sens. Tom Coburn, MD (R, Okla.), Judd Gregg (R, N.H.) and Richard Burr (R, N.C.).

Prescription freedom preserved

Dr. Coburn also championed an AMA-supported amendment that preserves physicians' discretion in prescribing drugs. An earlier version of the bill had included more-restrictive prescribing measures for drugs considered risky.

"The AMA worked with the Senate and will continue to work with the House to preserve physicians' ability to prescribe drugs without onerous government-imposed restrictions," Dr. Wilson said.

The Senate bill also provides the FDA with the authority to require drug companies to complete postmarketing safety studies, make label changes and communicate information about risks or face fines. The agency currently lacks this power.

Although a moratorium on direct-to-consumer ads for newly approved drugs was eliminated from the final measure, the bill does allow the FDA to fine companies that run false or misleading ads.

The House has yet to pass a companion measure, and the clock is running for both chambers to take final action to reauthorize the Prescription Drug User Fee Act, or PDUFA, before it expires on Sept. 30. As time for its that act's demise draws near, the agency has warned Congress that it soon must give termination notices to hundreds of employees whose salaries are paid through user fees.

Rep. John Dingell (D, Mich.) has indicated that he will hold hearings on the issue later this month.

Among the bills introduced in the House is one co-sponsored by Reps. Henry Waxman (D, Calif.) and Edward Markey (D, Mass.) that is similar to the Senate bill. Another measure, this one sponsored by Rep. Maurice Hinchey (D, N.Y.), takes a different approach and would, for one thing, establish a separate postmarket drug safety office at the FDA.

How these issues ultimately are addressed by the House remains to be played out. Meanwhile, the Senate bill received a mixed reaction from some close observers of the drug safety scene.

Although he welcomed the bill's safety provisions, Curt Furberg, MD, PhD, professor of Public Health Sciences at Wake Forest University School of Medicine in Winston-Salem, N.C., said that, if enacted, the provisions would amount only to "step one." Step two would be the FDA's using its new tools.

"In the past, [the agency] has not been very proactive," said Dr. Furberg, who is a critic of user fee funding of the FDA's drug approval program. He and others believe that taxpayer dollars should be the agency's sole funding source.

Dr. Furberg also was disappointed at the defeat of an amendment offered by Sen. Charles Grassley (R, Iowa) that would have separated drug approval and drug safety functions within the agency. But he hasn't given up hope that such a move will yet be made by a House bill. After all, he said, there is support for such a move, since the Grassley amendment came close to passing, losing by only one vote. "If we get a separate office of drug safety with separate funding and authority to take action, then we are in business."

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Bill provisions

A bill passed by the Senate on May 9 would reauthorize the Prescription Drug User Fee Act. It also contains the following provisions:

  • Requires that the Food and Drug Administration create a surveillance system to track emerging safety problems for approved drugs by mining public and private databases.
  • Allows the importation of drugs from Canada and several other countries, but only if the Dept. of Health and Human Services Secretary certifies the drugs' safety -- a goal not considered possible.
  • Requires that physicians be provided the necessary prescribing information for drugs considered to be risky, but does not restrict the distribution of medications by physicians.
  • Establishes an Advisory Committee on Risk Communication to determine how best to convey the dangers of pharmaceutical products. The expertise of medical societies will be tapped in forming the committee.
  • Gives the FDA power to fine food producers who fail to report contaminated products. Food from foreign companies would have to be inspected by the FDA before being sold in the United States.
  • Requires the registration of clinical trials in a publicly available database.
  • Allows for fines to be levied on companies that run false or deceptive direct-to-consumer ads. but doesn't impose a moratorium on ads for new drugs.

Source: FDA Revitalization Act (S 1082)

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