Office of Drug Safety. The Food and Drug Administration needs an independent office that would monitor the safety of drugs it approves and warn the public of emerging risks, a senior Senate Republican said Thursday.
Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) said he was drafting legislation to create such an office and give it authority to restrict the use of medications that develop safety problems.
The FDA has gotten “too complacent” about safety and “too cozy” with drug companies, Grassley declared in a speech to the Consumer Federation of America. He said he was working on the legislation with Sen. Christopher J. Dodd (D-Conn.), a member of the Senate Health, Education, Labor and Pensions Committee, which has oversight authority for the FDA.
“When the FDA approves a drug, it should be a Good Housekeeping seal of approval,” Grassley said. “Americans should be able to bank on the benefits outweighing the risks. Consumers shouldn’t have to second-guess the safety of what’s in their medicine cabinet.”
Grassley’s announcement was the latest move in a long-running struggle over how to strike a balance in the way federal regulators handle drug safety. Early in the AIDS crisis, critics charged that the FDA was too slow and cautious about approving drugs for desperately sick patients.
The agency responded by speeding up its clearance procedures. But more recently, evidence has surfaced that some drugs approved for sale posed safety risks that had not been detected and that the FDA’s system for monitoring medications once they reached millions of consumers was inadequate.
The Bush administration has acknowledged shortcomings in the FDA’s system
The Bush administration has acknowledged shortcomings in the FDA’s system. New drugs are tested, at best, on a few thousand patients before going to market. Rare side effects may not emerge until tens of thousands of people have used a medication.
While recognizing the problem, the administration is trying to head off legislation by undertaking a series of internal reforms at the FDA.
These include setting up a drug safety board that would report directly to top agency officials, and bringing in experts from the National Academy of Sciences to make recommendations about the FDA’s safety system. The agency also has pledged timely public release of information about emerging safety problems.
Grassley and other critics say the agency’s internal reforms would not solve a built-in problem: the FDA’s safety office is a unit of a much larger division that is responsible for reviewing new drugs and deciding whether they should be approved.
Creating a board to serve as an advocate for the safety office will not fundamentally alter that relationship, say the critics.
“If you want accountability, it doesn’t make sense to have the office that reviews the safety of drugs to be under the thumb of the office that puts the drug on the market in the first place,” Grassley said.
The new office he and others are proposing would have its own independent director and additional legal authority to require drug makers to change prescribing information. Grassley is also considering whether the safety office should have the power to suspend drug advertising or sales while a problem is being investigated.
Although Grassley heads one of the most powerful committees in Congress, he does not have direct jurisdiction over the FDA. That falls to the Health, Education, Labor and Pensions Committee, which is chaired by Sen. Michael B. Enzi (R-Wyo.).
Enzi is also considering legislation, but his spokesman said Thursday that he did not support Grassley’s approach
Enzi is also considering legislation, but his spokesman said Thursday that he did not support Grassley’s approach. “Sen. Enzi is not in favor of creating a separate [or] independent officer, either within or outside FDA,” Craig Orfield said.
Grassley, however, has hinted he may use his committee’s jurisdiction over Medicare and Medicaid to force changes at the FDA. The giant health insurance programs spend billions of dollars a year on prescription drugs.
Meanwhile, in another drug safety development Thursday, a consumer group challenged recent FDA assurances that the cholesterol-lowering drug Crestor is no more dangerous than similar medications.
Public Citizen said its analysis of drug injury data showed rare cases of life-threatening muscle damage were more likely with Crestor than with other so-called statin drugs.
The consumer group scrutinized reports of the muscle disorder rhabdomyolysis that were submitted to the FDA during a 12-month period ending in October. It said it found reports of 13 cases of rhabdomyolysis for every million Crestor prescriptions, a rate 6.2 times higher than for all statins combined.
Public Citizen has petitioned the FDA to ban Crestor, and the agency said it would withhold comment until it makes a formal response. AstraZeneca, which makes Crestor, defended its heavily advertised drug, saying it is safe and effective when used as directed.
“Public Citizen is basing its analysis on incomplete evidence and what we believe is unscientific information,” spokeswoman Kellie Caldwell said. The FDA said last week that patients taking Crestor should be started on a low dose.