Bipartisan Senate Bill Seeks to Tighten Rules for Drug Safety

Leading Republican and Democratic lawmakers unveiled legislation Wednesday that would give the government broad powers to ensure drug safety and regulate now-ubiquitous pharmaceutical advertising.

The bill by Sens. Charles E. Grassley (R-Iowa) and Christopher J. Dodd (D-Conn.) would expand the clout of the Food and Drug Administration’s safety office by making it a separate center within the agency, independent of the division that approves new drugs.

The new safety center would have an annual budget of $150 million by 2010 -- more than five times the funding of the current drug safety office.

The proposal, which has the backing of major consumer groups, goes well beyond the limited reforms announced by the Bush administration and is certain to draw industry opposition. A pharmaceutical lobbying group said Wednesday that it needed more time to review the legislation.

The bill also faces hurdles within Congress. Sen. Michael B. Enzi (R-Wyo.), chairman of the Senate committee that oversees the FDA, supports some new enforcement powers for the agency but opposes a separate safety center. Among House leaders, there seems to be little interest in large-scale FDA reforms.

However, Grassley and Dodd said they were confident that public support would propel their legislation forward. “The FDA has to be a vigorous watchdog,” Grassley said. “Some say we need a Rottweiler as opposed to a Chihuahua.”

The bill follows highly publicized debacles in which the FDA was slow to respond to evidence indicating serious risks from some painkillers and antidepressants. Grassley and Dodd embraced many reforms suggested by academics and other experts who follow the agency.

None may be more controversial than their proposed advertising rules.

Under the bill, advertising for any new drug must incorporate cautionary language, including the disclaimer that the medication’s risks are not fully known. The precautions would remain in force for two years after a drug’s approval. Drugs are tested on a few thousand people at most before approval, and some side effects may not emerge until tens of thousands of patients, or more, have taken them.

The director of the center also could impose warnings on ads for any drug that develops a safety risk.

“They are going to run into a bunch of problems, not the least of which is the 1st Amendment and a line of Supreme Court cases,” said Marc J. Scheineson, a former senior FDA lawyer who now represents industry clients.

Scheineson predicted that another proposed requirement -- that drug companies submit advertising to the FDA for pre-publication review -- would create an unworkable logjam. “You’re talking hundreds of thousands of pages of print and media advertising a month,” he said.

But Dodd pointed to a recent study indicating that drug company ads can influence doctors to write prescriptions, even in cases in which patients’ symptoms aren’t very clear. “We’ve moved into a new world here,” he said Wednesday. “That’s why this issue is in the bill.”

Dodd and Grassley said that to eliminate possible conflicts of interest, the drug safety office must be separate from the division that reviews and approves drugs.

Under their bill, the safety center would have the power to force manufacturers to carry out post-approval studies of new drugs. If studies yield evidence of safety problems, the center would determine whether the data indicate an “unreasonable risk” compared with a medication’s known benefits.

If such a risk is found, the center could take actions that include adding warnings to prescribing information, restricting distribution and requiring patients to sign a statement that they understand a drug’s potential dangers. The FDA already has the authority to take a drug off the market.

By giving the FDA explicit authority to require safety studies and take a variety of enforcement actions, the legislation improves on the current system, supporters say. Such enforcement measures are now usually worked out in negotiations with drug firms, which can drag on.

“If enacted, this legislation will be very effective in preventing situations where consumers are taking a drug for years and the FDA has had safety concerns and failed to act,” said Jeannine Kenney, a legislative advocate with Consumers Union, which publishes Consumer Reports magazine.