Time for a fresh start for the FDA

The US Food & Drug Administration has long played a vital role in protecting Americans and setting high standards for other regulators around the world. But it is currently sick, and Barack Obama, president-elect, should move swiftly to restore it to health.

The FDA has been lambasted by politicians over side-effects of the diabetes drug Avandia, and the failure to prevent the import of contaminated products from China, including the blood thinner Heparin and baby milk containing melamine.

It is accused by doctors and patients’ groups of being too cosy with companies. Industry, by contrast, says it is too slow and risk averse, unexpectedly shifting the criteria for approvals.

The European Medicines Agency has moved more swiftly than the FDA in approving some new medicines, establishing principles for generic biological drugs and fostering partnerships with commercial and academic researchers to rethink regulation.

The FDA’s staff and counterparts in other agencies talk of poor internal management, and its own advisory committee warned in 2007 that poor recruitment and retention meant its scientific base was weak.

Some of these issues have already been recognised, with long overdue extra money pledged, international inspections and co-operation stepped up, and new IT and safety surveillance programmes launched. But doubts linger among demoralised staff, suspicious citizens and frustrated companies.

The first action of the new administration should be the swift appointment of a strong, respected, knowledgeable and independent new commissioner. For more than four years, the FDA suffered under bosses not formally confirmed, or who failed to defend it robustly. Its next leader needs to take full responsibility for the agency with maximum political support.

That person must investigate allegations of conflicts of interest. Just as important, he or she must ensure clearer future rules. Products that fail to meet regulatory hurdles should be rejected, but the FDA must be clearer with companies in how it makes decisions, and stick to them.

Finally, the commissioner needs to prepare for a new era, better communicating the relative risks and benefits of products to the public, reinforcing safety after products are launched, and developing a strategy that reflects the scientific and commercial challenges of the new century. The best result for society is unfortunately a thankless one for the agency: fewer high-profile, health-related scandals.