Congress gave final approval Thursday to legislation designed to transform the Food and Drug Administration from a passive monitor to an active detective seeking out medications that have been approved for sale but turn out to be hazardous -- a problem linked to an estimated 15,000 deaths a year.
The drug-safety provisions were the centerpiece of a massive bill that also would renew industry user fees that fund the FDA’s review of medications and medical devices submitted for approval.
The Senate passed the bill without objection Thursday evening after the House overwhelmingly passed it Wednesday. The White House has not commented on the final version of the bill, but President Bush is expected to sign it, congressional aides said.
In addition to building a new computerized system to spot drug risks, the bill would strengthen the FDA’s enforcement powers and require greater disclosure of private and public clinical research and of agency decision-making. It also would take steps to reduce FDA reliance on outside advisors with financial conflicts of interest, as well as create a new program to review drug company advertising.
“This ought to be reassuring for every family about the safety of their prescription drugs,” said Sen. Edward M. Kennedy (D-Mass.), one of the main authors of the bill.
Consumer groups hailed the legislation as a major accomplishment, achieved with a high degree of bipartisan consensus. But some scientists said that the new drug safety system could take years to refine and that in the meantime, consumers were likely to face more drug scares.
“This is a different way of doing business for FDA, and there are going to be some real challenges in implementing it effectively,” said Mark B. McClellan, FDA commissioner from 2002 to 2004. “It’s going to shift the focus away from information provided by the drug manufacturers to much broader sources of information in our healthcare system.”
One important challenge is developing a reliable method of distinguishing between true drug safety issues and false alarms, a problem that experts say is relatively common.
“This is a wide-open area, [and] nobody really knows how to do it,” said Sean Hennessy, an epidemiologist at the University of Pennsylvania medical school. “There will be potential threats that are later disproved. The danger is that people will act on information that is later shown to be false.” And that could be damaging to the FDA’s credibility.
Nonetheless, serious drug reactions appear to be on the rise. According to a recent study of reports to the FDA, there were nearly 90,000 such cases in 2005 -- including more than 15,000 that resulted in death and nearly 5,700 in which the patient was left with a disability. Though some of the problems, like the heart risks of the painkiller Vioxx, are widely publicized, many receive little notice.
Under the current drug safety system, the FDA approves a new medication after it has been tested on a few thousand people at most. Then agency scientists stand by and wait for reports of any problems that may surface when the drug is used by tens of thousands or even millions of patients. Often, such problems go unnoticed until a substantial number of people have been affected.
Under the bill, the agency would set up a new computerized system to scan pharmacy and insurance records for patterns of problems with medications. The legislation calls for a database of 25 million patients by 2010, growing to 100 million by 2012.
For example, such a database could be used to compare patients taking a new painkiller with patients taking an older one. If the patients on the new drug start showing up in emergency rooms with heart attack symptoms in disproportionate numbers, that could be an indication that the drug is to blame.
But there might other explanations. Perhaps the new drug is being prescribed to older, sicker patients. Or maybe it’s being prescribed for unapproved uses. That’s where the legislation would give the FDA new legal authority to require drug makers to conduct follow-up studies, including clinical trials, to try to pin down safety problems with medications already approved for market.
And if such problems are found, or strongly suspected, the bill gives the agency greater leverage in requiring drug companies to make changes in their prescribing literature to alert doctors and patients.
Several private companies and academic centers are already using such databases. Dr. K. Arnold Chan, a senior scientist with i3 Drug Safety, said the FDA and drug companies had used his company’s system to check the validity of anecdotal reports they received on a range of medications. Chan’s company is part of UnitedHealth Group, the giant Minnesota-based insurer.
“The traditional mode is more reactive than proactive,” Chan said. “When a new drug comes on the market, you sit back and wait for anything potentially bad to happen. If it does happen, then you do something. But that’s not the best system for the 21st century.”
The company has records of about 15 million patients in its database, which was activated in 2005. It is being used to study newly approved drugs for a three-year period.
FDA officials declined to comment, noting that the legislation has not been signed.
But Dr. Bruce Psaty, a prominent academic critic of the agency, said officials should use the new database in a targeted way, to follow up on hints of problems that sometimes emerge in the limited testing conducted before a drug is approved. Such pre-approval testing, for example, may indicate that a new drug tends to raise blood pressure. Does that mean patients taking it over many months will be at greater risk of a heart attack?
“A key component of the future safety studies will be to take the issues that come out of animal studies and pre-approval clinical trials and translate them into high-quality [post-approval] studies,” said Psaty, a professor at the University of Washington medical school in Seattle. “That is a critical step for ensuring safety.”
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Highlights of the final bill passed by Congress:
* Renews and increases industry user fees to the Food and Drug Administration for review of new medications and medical devices.
* Creates an FDA database of insurance and pharmacy records for 100 million patients that can be searched for emerging drug safety problems.
* Gives the FDA new legal authority to require drug firms to conduct safety studies of medications already on the market.
* Gives the FDA greater leverage to require companies to issue warnings when problems arise with a medication.
* Improves the government’s online registry of clinical trials and creates a new public database for results of clinical trials.
* Requires the FDA to reduce the number of outside experts with financial conflicts that serve on its advisory panels.
* Establishes a new private-public partnership to help modernize drug development in the coming era of genetic medicine.
* Improves reporting of food- safety problems.
* Sets up a new program to review drug company advertising and requires ads to carry information on how to report problems.
Source: Times reporting