) Vioxx may cause heart attacks and strokes, and by charges by Dr. David J. Graham, one of the agency's own drug safety officials, that the "FDA is incapable of protecting America against another Vioxx." Lawmakers are talking about strengthening drug safety -- and Big Pharma is trying to preserve quick approvals without losing more public confidence.
For drugmakers, the challenge is to find just enough regulation. They don't want new FDA authority to order expensive trials of drugs already on the market. But without better monitoring of drug safety, the battered FDA could grow increasingly cautious about new medicines.
The first legislative salvo came on Jan. 21. Senator Chris Dodd (D-Conn.) unveiled a bill that would establish a new $100 million-a-year Office of Patient Protection with power to demand new studies for approved drugs and to take drugs off the market. Senate Finance Committee Chairman Chuck Grassley (R-Iowa) says he will jump in soon with his own measure establishing an independent drug safety office.Declaration of Independence?
But drugmakers are paying special attention to the Senate Health, Education, Labor & Pensions Committee. GOP Chairman Mike Enzi of Wyoming is teaming up with ranking Democrat Edward M. Kennedy of Massachusetts to hold hearings -- and perhaps introduce a bipartisan bill. Congress needs "to determine whether changes in law or regulation are necessary to protect public health," says Enzi.
One problem, congressional investigators believe, is that FDA drug approvers also make the decisions about whether to withdraw drugs. In contrast, scientists like Graham, charged with assessing the safety of drugs already on the market, have little clout and resources. That's why there's so much talk about making the drug safety office independent. It will also help to have a permanent FDA chief, and one may be nominated soon. A top contender: Acting Commissioner Lester M. Crawford Jr.
But an independent office won't accomplish much without more funding. "We need new systems to monitor the use of drugs," explains Acting Deputy Commissioner Janet Woodcock. In a time of tight budgets, finding money for drug surveillance won't be easy. FDA officials hope that, when the bill requiring industry to pay "user fees" for drug reviews is renegotiated, drugmakers will add money for drug monitoring. "How can they refuse to pay more in light of Vioxx and David Graham?" asks one FDA official.
For industry, more expense could be the lesser of two evils. Stronger aftermarket reviews could boost public confidence in drugs -- and might even help Big Pharma win caps from Congress on product-liability damages for FDA-approved drugs. The biggest concern, says James Greenwood, head of the Biotechnology Industry Organization, is that congressional action might have "unintended consequences that would slow down the approval process for drugs." That probably won't happen. But for the first time in a decade, Congress is paying more attention to drug safety than simply to speeding drugs to market. For four years, Democrats have blocked President Bush's plan to drill in the Arctic National Wildlife Refuge. But Republicans may try an end run. How? By taking the controversial drilling provision out of long-delayed energy legislation and including it in the budget instead. Then the GOP could pass the ANWR provision with a simple majority, not the 60 votes needed to overcome a filibuster on nonbudget legislation. That would also make it easier to win passage of an energy bill. Democrats worry that Bush may replace both of the Securities & Exchange Commission's reform-minded Dems this year. Commissioner Harvey J. Goldschmid plans to return to the Columbia Law School faculty this summer. But fellow Dem Roel C. Campos wants to stay on when his term is up in August. Democratic leaders on the Hill want to keep Campos, too, but it isn't clear how much say they'll have. Corporate attorney John Olson and Texas Securities Commissioner Denise Voigt Crawford are viewed as possible White House replacements. A year ago, Washington was debating whether the new Medicare drug benefit would cost $400 billion over 10 years or $534 billion. Now the Congressional Budget Office says the tab will hit $800 billion from 2006 to 2015. Why? The slow-starting program cost little in 2004-05 -- but will zoom past $100 billion a year in 2013.