Are drug makers buying FDA approval?

In 1992, the U.S. Food and Drug Administration began receiving much of its income from the companies it's supposed to regulate: the drug manufacturers. At the time -- and ever since -- critics said the plan, called the Prescription Drug User Fee Act (PDUFA), is like asking the wolf to guard the sheep. When their salaries come from the drug makers, there can be little assurance that FDA officials will put public safety first.

Time has proven the critics right. A new government report shows that since the PDUFA was implemented, an increased number of newly approved drugs have been found to be unsafe and have been withdrawn.

This isn't the first time that flaws in the FDA policy have been exposed.

In 1998, the health consumer advocacy group Public Citizen conducted a survey of the physicians who review new drug applications -- the people who are supposed to be the final judges as to whether a drug is approved. It found that, in the previous three years, the reviewing physicians had opposed the approval of 27 drugs -- yet all got the go-ahead from the FDA! The report documented how physicians were precluded from presenting data adverse to the drugs they were reviewing at FDA Advisory Committee meetings.

The General Accounting Office's (GAO) conclusions confirm the major public health consequences of PDUFA, which introduced private money, and therefore influence, into the drug approval process, creating a massive conflict of interest. One result of PDUFA has been the diversion of agency funds to the review process from other areas, including post-marketing safety surveillance.

FDA approvals of unsafe drugs have led to unnecessary patient deaths and illnesses, as well as poor morale among drug reviewers (the GAO report also documents that staff turnover is higher among FDA scientists than among scientists in other government agencies).

"Congress should immediately conduct meaningful oversight hearings on each of the drugs that has been withdrawn for safety reasons," argued Peter Lurie, deputy director of Public Citizen's Health Research Group. "Drug makers have benefited from PDUFA, making millions in profits off drugs that should never have been brought to the market. Congress must adequately fund the FDA's drug approval activities and remove private influence from the equation."

SOURCE: GAO Report Backs Link Between Drug User Fees and Higher Rate of Drug Withdrawals, Public Citizen, Sept. 25, 2002.