Prescription drugs would be monitored more closely for side effects under legislation the Senate approved Wednesday aimed at staving off future high-profile drug withdrawals.
Federal health officials were criticized for not reacting sooner when serious problems were linked to the painkiller Vioxx. The drug was withdrawn voluntarily in 2004 after research showed it doubled the risk of heart attacks and strokes.
The Senate legislation, approved on a 93-1 vote, would require the Food and Drug Administration to actively monitor the safety of drugs on the market and require pharmaceutical companies to develop plans to manage any serious risks associated with new medications.
A companion bill has yet to be considered in the House.
The legislation’s underlying purpose was to renew, through 2012, a program that has the drug industry pay fees to the agency to defray the cost of reviewing new medicines.
But in the wake of the Vioxx withdrawal, lawmakers seized on the bill to overhaul how the FDA handles the safety of the drugs it regulates.
Drug companies would be required to do follow-up studies on certain medicines or risk fines. The FDA could require label changes for drugs.
An active surveillance program would replace the largely passive way the FDA
An active surveillance program would replace the largely passive way the FDA now learns of potential problems with drugs on the market. It calls for the mining of federal and private databases that log side effects in tens of thousands of patients.
“Right now, the FDA has its hands tied behind its back when it tries to manage the risks of drugs already on the market. This bill will clarify and strengthen the FDA’s authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americans,” said Sen. Mike Enzi, R-Wyo., who wrote the main piece of legislation with Massachusetts Democrat Sen. Ted Kennedy.
Stripped from the legislation was a provision that would have placed a freeze on consumer advertising of newly approved drugs. The final bill does allow for fines for ads that are false or misleading.
Kennedy called the measure “constitutionally sound” after lawmakers objected, on free speech grounds, to any advertising freeze.
The Senate also voided an effort to allow consumers to buy prescription drugs from abroad at a significant savings over domestic prices.
The bill would require stricter production and labeling standards for cat and dog food so people have more information about what they are feeding their pets.
It also would reauthorize a related user-fee program for medical device manufacturers and legislation meant to ensure that drugs and devices for children are safe and effective.
Too many lives have been lost because the FDA has been too slow to act or didn’t have the power to change a warning
“Too many lives have been lost because the FDA has been too slow to act or didn’t have the power to change a warning label or require a follow-up safety study,” said Bill Vaughan, senior policy adviser for Consumers Union.
“It’s now up to the House to get the strongest possible reforms approved so patients can have faith in the medicines they take each day,” he said.
The FDA’s proposal to Congress called for the drug industry to pay $393 million in annual fees; the Senate bill proposes increasing that by $50 million to defray added drug safety costs.
Overall, fees cover a majority of the FDA’s drug-review budget, with taxpayer dollars making up the rest.
The FDA’s entire annual budget is roughly $1.8 billion.