A Case of Kessler at the FDA Helm

There are pills that can reduce a woman’s chance of becoming pregnant by 75 percent if she takes a dose within 72 hours of having sex. Few women realize this, though many have been taking the pills for years as a means of birth control, because drug companies lack the approval of the Food and Drug Administration (FDA) to market them as “morning after” pills. While drug manufacturers have been assured that FDA approval would be granted, they are reluctant to spend the requisite time and money on the FDA’s notoriously lengthy application process. Unfortunately, this is not an isolated situation. FDA red tape has prevented many potentially beneficial products from entering the US market. This is a serious problem, considering the wide scope of the FDA’s jurisdiction, over food, food additives, drugs and medical devices, TVs, microwave ovens, and pet products – accounting for $960 billion worth of goods.

Dr David A Kessler who took over as commissioner in 1990, made it his mission to turn things around at the FDA. In addition to bringing FDA practices up to speed, Kessler confronted the difficult task of restoring the agency’s credibility and morale after the 1989 generic drug scandal which ended in the conviction of four FDA employees for taking “illegal gratuities”. In order to restore faith in the agency, his first steps included cracking down on everything from falsely labeled “fresh” orange juice to allegedly dangerous breast implants.

Then came the formidable challenge of streamlining the cumbersome bureaucracy that had traditionally plagued the FDA. Kessler began by delegating authority to the 21 field offices, empowering the lower level FDA managers, and reducing the frequency of review by headquarters. This enabled the FDA to expedite enforcement actions and drug reviews. Moreover the time necessary to process injunction requests was reduced by 60 percent. Kessler also acquired congressional approval to bill companies for drug evaluations, and thereby increased the FDA’s 1993 budget to $826 million, up 8.7 percent from the previous year. Extra reviewers were then hired in an effort to cut the average drug approval time from 22 months to 12 months by 1997.

In order to transform the FDA into a more efficient regulator, Kessler borrowed what he called “the best practices of the private sector.” This has involved rehiring reorganizing and restructuring. From 1990 to 1993 total staff grew from 7,800 to 9,000. The first day I got here, I was called to the Health & Human Services Dept. [the FDA’s parent], recalled Kessler. For a whole day, nothing else got done. He immediately put five deputies in place to oversee policies, manage crises, deal with Congress and the outside world, handle daily operations and, overhaul the agency’s ancient communications systems. In the past, management [at the FDA] meant doing the budget, allocating office space, and doling out parking spots, remarked Kessler. The agency never asked how work should get done. Under Kessler this has changed.

In addition, Kessler has focused the FDA’s centers for biologics and foods on product approval by reorganizing them around products instead of scientific disciplines. This resulted in the on time implementation of the 1990 Nutritional Labeling & Education Act. Instead of having food labeling expertise scattered throughout the FDA, Kessler’s restructuring placed it all in a single division. We would never have gotten food labeling done had it not been for the reorganization, said Food Safety center director Fred R Shank.

Kessler has also made the FDA more user-friendly. Each agency center previously had its own forms and requirements for companies wishing to report adverse reactions to products. Now, all of the centers share the same forms and requirements, and interaction is encouraged between similar divisions who formerly worked autonomously. Moreover, Kessler has refused to accept substandard Applications in an attempt to force companies to submit better ones. In fact, 30 percent of applications are now refused, whereas applications were rarely refused previously.

But there could be a downside to a more efficient FDA. Many people have expressed concern that expediting the FDA’s approval process will result in an increase in potentially harmful drugs being made available. The public has traditionally expected FDA to keep unsafe and ineffective drugs from being approved and marketed John Petricciani vice president for medical and regulatory affairs for the Human Health Services Association, pointed out. [T] here has been a growing recognition of the other side of consumer protection, and that is to approve safe and effective drugs in a timely manner. As the Agency begins to move towards more rapid approvals, there will also be heightened expectations of the FDA to monitor the safety and efficacy of drugs after approval.

Recognizing this, Kessler has responded with the implementation of MED Watch, a program designed to encourage voluntary reporting of adverse reactions by health professionals. This is not just a new FDA system, Kessler noted, it is a way of making reporting of adverse events and product problems a part of the culture of healthcare providers. Physicians, nurses, and others who care for patients are the first to know when a drug or medical device does not perform as it should. The sooner they report it to FDA, the faster the agency can analyze the problem and take corrective action. MEDWatch is designed to correct for the fact that health professionals are not legally required to report and that as many as 50 percent are not even aware that they can report. The goal of MEDWatch is therefore to make health professionals aware that they can report and to make the process easy.

MEDWatch is symbolic of the great strides taken by the FDA under Kessler’s influence. The changes have been excellent first steps noted Kenneth P Berkowitz, a vice president at drug maker Hoffmann La Roche Inc. Kessler has planted the seeds for a more effective FDA.