Senate passes drug safety overhaul bill

Times Staff Writer

The Senate overwhelmingly approved a landmark drug safety bill Wednesday, doubling the number of government scientists assigned to ferret out risky side effects in medicines already on the market.

The measure also would create a computerized network to scan medical insurance and pharmacy records for signs of trouble with new drugs, and significantly expand the Food and Drug Administration’s power to require drug makers to reduce risks.

“This is unquestionably the biggest change in the FDA’s regulatory authority in a very long time,” former agency Commissioner Mark B. McClellan said. “It is really a new era for the FDA that will start after this law is implemented.”

The Senate bill was drafted in response to highly publicized safety lapses -- including the belated withdrawals of the painkiller Vioxx and the diabetes drug Rezulin, as well as the FDA’s tardy warning about the suicide risks of antidepressants.


Rezulin, which was found to cause liver failure, was pulled from the U.S. market after being cited in more than 500 deaths. Vioxx was found to increase the risk of heart attacks.

David Willman, a veteran reporter in The Times’ Washington Bureau, won a Pulitzer Prize in 2001 for his investigation into FDA approval of seven drugs, including Rezulin. The Times investigation found that the FDA had given the drug fast-track approval despite concerns within the agency over its safety.

The Senate legislation also addresses consumer complaints about misleading drug advertising by setting up a voluntary program through which the FDA would review television commercials before they are aired.

After a week of contentious debate and an unsuccessful effort to add a provision that would allow consumers to buy drugs from foreign suppliers, the Senate approved the bill, 93 to 1. Sen. Bernie Sanders (I-Vt.), a strong critic of the drug industry, cast the “no” vote. The drug importation amendment, opposed by the Bush administration, could have stalled the safety overhaul.


The House is expected to write its own version of the legislation soon. Its approach is likely to be tougher on industry, but senior House lawmakers have praised the Senate’s basic approach. They say they hope to get a bill to President Bush by summer.

The safety provisions are part of a larger bill reauthorizing industry user fees that now provide about half the funding for drug review and approval.

Some consumer groups and lawmakers oppose using industry fees to fund the FDA, saying it creates a conflict of interest. Nonetheless, the legislation is considered must-pass because if Congress fails to act by summer, the FDA could be forced to notify hundreds of senior scientists, doctors and statisticians -- whose skills are in demand in private industry -- that their jobs might be at risk.

Drafted by Sens. Edward M. Kennedy (D-Mass.) and Michael B. Enzi (R-Wyo.), the Senate bill would more than double the size of the FDA’s safety office, which now has a staff of about 90. The cost of that expansion would be covered by user fees, which would rise from a total of more than $300 million this year to $539 million in 2008 and $916 million in 2012, according to Senate staffers.


“This legislation [will] bring the Food and Drug Administration into the 21st century,” Kennedy said. “It greatly improves the way the FDA oversees the safety of drugs.... When patients are in danger, the FDA should not have to wait to get legal opinions ... to protect health.”

With nearly half of U.S. adults taking at least one prescription medication, the risk of dangerous side effects has become a much bigger concern in recent years.

Under the current system, new drugs are tested on no more than a few thousand people before approval, and rare side effects might not emerge until many more patients have used a medication. Some prominent medical experts believe all drugs should be considered experimental for at least two or three years after approval.

The computerized surveillance system outlined in the bill would provide a way to keep closer tabs on newly approved drugs.


The FDA’s current system relies on anecdotal reports from doctors and picks up only a small fraction of adverse reactions. The legislation would incorporate that system into the broader surveillance network for all new drugs.

“The legislation allows for routine, active safety monitoring using large linked databases,” Enzi said. “What I like to call ‘Health IT’ for drug safety.”

The network would scan millions of records in billing files from government healthcare programs and private insurers. Patients’ identities would be protected.

The system would raise a red flag if, for example, billing records indicated that arthritis patients given a new painkiller were more likely to get treated for heart trouble than similar patients taking an older drug. Precisely such a research finding from a large health-maintenance organization’s database provided the initial unheeded warnings about Vioxx.


The bill also would give the FDA new legal powers in dealing with drug companies. Regulators would be able to order additional safety studies of approved drugs, and would have more leverage to impose warnings and change prescribing instructions for doctors.

The FDA currently can only ask manufacturers for follow-up studies, and such requests many times are ignored. Often, the agency must go through protracted negotiations with a manufacturer to get a stronger warning.

The new powers would be used to craft an individual risk management plan for any drug thought to pose a significant danger. Pharmaceutical companies that violate the risk plans would face fines of up to $2 million under an amendment offered by Sen. Charles E. Grassley (R-Iowa). It was approved, 64 to 30.

The industry has raised concerns about the risk plans, but after the vote the Pharmaceutical Research and Manufacturers of America -- the main trade group -- issued a statement saying the bill would “no doubt make a good system even better.”


The bill also contains provisions that would reduce secrecy in the drug development process by requiring public disclosure of most clinical trials and the release of memos that reflect internal FDA dissent about medications awaiting approval.

“This will bring to the FDA the ability to dissent without getting shipped to the outer Aleutian Islands,” said William Vaughan, a policy analyst for Consumers Union, publisher of Consumer Reports.

Consumer groups are divided over the legislation because of differences over the government’s reliance on user fees.

Consumers Union supports the bill whereas Public Citizen, a watchdog group founded by Ralph Nader, opposes it.


In a letter to Congress, Public Citizen urged lawmakers to reject user fees for the FDA and to instead use tax revenue.

“The agency has become dependent for its funding upon the very industry over which it has regulatory authority,” the letter said. “This is an unacceptable conflict of interest.... Protecting the integrity of drug approvals is a legitimate federal function, and one that should therefore be fully funded from federal coffers.”




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Drug safety

Some highlights of the prescription drug safety bill passed by the Senate:


* Creates a computerized system to monitor potential problems with new drugs.

* Gives the Food and Drug Administration stronger legal powers to require follow-up safety studies and stronger warnings for medications already on the market.

* Provides significant increases in funding and staff for the FDA drug safety office.

* Expands public disclosure of clinical trials and their results.


* Requires the FDA to release dissenting opinions of agency scientists.

* Imposes stricter conflict-of-interest rules for the FDA’s outside advisors.


Source: Los Angeles Times reporting