NEW YORK (CNN/Money) -
The FDA now gets more than half the money it needs for testing new drugs from drugmakers themselves, raising questions about whether the agency can be trusted to protect consumers.
Under fire over drug safety and under pressure to speed new treatments to market, the Food and Drug Administration spent more than $400 million last year reviewing new product applications, with 53 percent of that coming from drug companies.
Since 1992, when the Prescription Drug User Fee Act was passed to help speed up the sluggish drug review process, drugmakers have paid fees to the FDA to help review new drug applications.
But pressure to speed up the review process could strain the FDA's resources and increase the chance of another Vioxx-style drug slipping through cracks in the review process, said Fran Hawthorne, author of "Inside the FDA."
Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, the trade group representing big drugmakers, said the additional funds from the industry don't compromise safety. Instead, he said, the funds help FDA reviewers scanning potential new medicines.
Former FDA official Wayne Pines said the fees help "staff the FDA sufficiently to be able to review products in a timely manner" with data-based judgment that doesn't bow to outside pressure.
In the year ended Sept. 30, 2004, the latest numbers available, the FDA spent $437 million to process drug applications. In that year, fees from the drug makers surpassed tax-based contributions. Drugmakers provided $232 million, compared to the taxpayers' $205 million, according to figures from the FDA.
So what's the big deal?
The balance has shifted since 2003, when taxpayers carried the bigger burden. That year, fees from drug companies brought in $200 million, less than half the total drug review budget, and tax-based appropriations came to $209 million. Since then, drug makers started carrying the biggest budgetary share for the agency that reviews their products.
The recent shift in balance, and whatever it might suggest about the Big Pharma's influence over the FDA, will be subject to scrutiny at the FDA's public forum in Bethesda, Md., later this month. The FDA is asking people what they really think about the law before it comes up for reauthorization in 2007.
The law doesn't seem to be in any real danger. The act has been re authorized by Congress several times since former President Bush passed it 13 years ago. Pines, who was a public affairs officials with the FDA for 10 years and who co-authored "Strategic Communication Before, During and After Your Drug's Approval," dismissed as "severely flawed" the idea that drug makers' fees wield influence over the FDA.
"I do not believe that PDUFA influences the final decisions in any way," said Pines. "Those decisions are made by health professionals on the basis of data and a judgment on the benefit-risk ratio of a particular product."
Hawthorne also doubted that Big Pharma influences regulators through fees.
"In theory, [the drug act] sounds like who calls the piper plays the tunes, but that's much too simplistic," said Hawthorne, adding that if the industry didn't provide $232 million, then it would come out of taxpayers, which would be politically impossible.
"[Congress] is not going to raise taxes. Nor are they going to slash the FDA's budget 50 percent. The question with the renewal is: will they tighten the [fast track] deadline again? If they tighten any further, you're just asking the FDA to put dangerous drugs on the market."
Hawthorne was referring to the FDA's fast track, or accelerated, review process for potentially life-saving drugs, like treatments for heart disease and cancer. The FDA tries to get fast track drugs approved within six months, compared to its 10-month goal for non-accelerated review.
The FDA met its fast track goal in 2004 and shaved the average approval time for other drugs down to 12.9 months from 15.4. Critics like Hawthorne believe this increases the chance for dangerous drugs to slip past regulators.
"When (the law) was approved, it took two years to review a drug," said Hawthorne. "That's unreasonable. People could die waiting for a drug to be approved. But right now, you have the most innovative drugs that are supposed to be decided within six months. These are the ones that are the hardest to review, but they have the tightest deadlines."
Trewhitt of the industry group rejected claims that the law endangers the public. Trewhitt said the law has helped, not hindered, the FDA and millions of patients.
It's "allowed the FDA to improve the efficiency of the drug review process by hiring drug reviewers and by buying more scientific equipment," said Trewhitt.
"This has been done without sacrificing drug safety. Fewer than 3 percent of pharmaceutical products has been withdrawn from the market for safety reasons in the last 20 years and there has been no up-tick in recent years."
Despite the situation with Vioxx, the FDA-approved painkiller that Merck pulled off the market in 2004 after studies showed it increased the risk of heart attack and stroke, Trewhitt said that safety is not the casualty of efficiency.
"Over the last couple years, a half dozen or so pharmaceutical products have been cited for having safety problems," said Trewhitt. "To put that in perspective, there are today nearly 2,500 brand name medicines on the market. And in the vast majority of cases, they are safely and effectively treating patients."
Trewhitt said he is "comfortable" with a six-month review for fast track drugs to provide them to seriously ill patients "in a timely manner" and would like to see the FDA meet its 10-month goal for other drugs.
As for Vioxx, the former FDA official Pines said the public needs to lose its expectation "that a drug will be completely safe for all patients, which is never the case, and never will be."
"The cases we read about, when drugs are withdraw, are situations in which new data changes that benefit-risk judgment," said Pines. "Every drug with any potency has side effects; the issue is not the side effects, it's balancing those risks against the hoped-for benefit."
To read about the FDA and fast-track cancer drugs, click here.