Is Drug Safety Being Enron'd?

By Diana Zuckerman

March 25, 2002 - When the leadership at Enron decided profits were more important than protecting their employees and stockholders, a lot of people lost their life savings. When companies making medical products put profits before public safety, people lose their lives.

You would think that the Enron debacle had taught us that we can't trust companies to be totally dedicated to consumers. You would think we had learned that government regulation can be a very important safety net - and that meetings between the regulators and the industry they regulate should be public, not secret. You'd be wrong.

If you think PDUFA is the latest boy band to compete with 'NSYNC, then you will be surprised to hear that there were Congressional hearings on PDUFA in Washington, DC recently and more planned in the weeks ahead. PDUFA is the Prescription Drug Users Fee Act for the U.S. Food and Drug Administration (FDA). And although it rarely gets media attention and many members of Congress don't know what it is, it is probably the most important health bill that will be passed in the US this year. The lives of virtually all Americans will be influenced by this legislation, and the negotiations to renew and revise this law have taken place in secret, between pharmaceutical companies and FDA officials.

The goal of PDUFA is to push the FDA to approve drugs more quickly. It mandates companies to pay fees to the FDA to review their new drugs and vaccines, and the fees are used to speed up that process. Speedier approvals can save lives when the products are medical breakthroughs. But we have learned the hard way how fatally flawed that quick approval process is. Seven widely used drugs have been withdrawn from the market for causing death and terrible illness in the last few years, and most of them came to our pharmacy shelves via PDUFA and its quick approval process.

Unfortunately, this process doesn’t provide much benefit to consumers, since most approvals are for "me-too" drugs that merely do the same thing as other products that are already available - whether antibiotics or allergy pills or headache remedies - and sometimes for much higher prices.

Has PDUFA turned the FDA into a sleeping watchdog that cares more about approving drugs quickly than making sure they are safe? Once a new medical product - a drug, vaccine, or implanted device -- is approved, the FDA rarely requires the manufacturer to submit studies examining the long-term safety. And yet, as baby boomers age, many are taking drugs for years to control chronic diseases, or living with "spare parts," such as heart valves, artificial hips, or other implanted devices, whose long-term safety has never been studied.

Unfortunately, the drug companies like PDUFA the way it is and many members of Congress seem more concerned about the interests of companies in their backyard than the consumers who live next door. Last time, PDUFA passed with the help of a Senate staffer with ties to the drug industry. This time, it may be former House and Senate staffers and FDA officials who, currently lobbying for the pharmaceutical industry, give drug companies the bill they want.

The current PDUFA only includes speed of approval as a performance goal, rather than public health performance goals such as reducing the number of patients dying from what are euphemistically called "adverse reactions."

Consumer groups have very reasonably asked the FDA to consider adding public health performance goals. Instead, FDA officials have been negotiating secretly with the pharmaceutical industry, and have not included any public health goals.

When the regulators are making a deal with the companies that they are supposed to regulate, consumers better beware.

Seem familiar? So far, the media has hardly covered this story. Much of the public focus is on last year's secret meetings between Enron and Bush Administration officials, and the past harm done to consumers -- while secret meetings with pharmaceutical and medical device companies are underway and ignored.

The real lesson from Enron should be to cover the story before disaster strikes.

Diana Zuckerman, Ph.D. is president of the National Center for Policy Research (CPR) for Women & Families, a nonprofit, nonpartisan organization that uses research to inform public policy. She previously was a Congressional investigator on FDA issues.

Diana Zuckerman can be reached at dz@center4policy.org.

The National Center for Policy Research