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FDA, Measure (And Improve) Thyself

April 23, 2014

By Paul Howard

The U.S. Food and Drug Administration is arguably the most important regulatory agency in the country—regulating everything from the safety of imported seafood to the latest medicines developed for cancer and Parkinson’s. Yet when things go well, FDA Commissioner Margaret Hamburg typically hears little praise from Congress and the media. But when crisis—real or perceived— strikes in food or drug safety, the agency faces withering criticism on the Hill.

There’s got to be a better way to routinely evaluate the FDA’s performance than trial by crises. The agency, after all, is enormously complex (with nearly 15,000 employees and dozens of centers and divisions), and like any complex organization, performance across divisions is bound to vary significantly.

In one area, review of new medicines for marketing approval in the U.S., variations in performance across the agency’s drug review divisions can lead to lives lost for patients, who have to wait longer for life-saving or life-extending new medicines. This isn’t a criticism—it’s just reality. As such, giving the FDA’s leadership better tools for evaluating internal performance can lead to a better organized, more efficient agency that acts as a bridge for delivering new medicines to patients as quickly and safely as possible. And while not everything worth measuring can be measured, all things measurable can be improved through routine process and performance analysis.

In a new report for the Manhattan Institute, An FDA Report Card: Wide Variance in Performance Found Among Agency’s Drug Review Divisions, researchers Joseph DiMasi, Christopher-Paul Milne, and Alex Tabarrok find significant differences in performance among the agency’s 12 major pharmaceutical review divisions from 2004-2012. (Their dataset accounts for nearly 200 new drugs and 80 percent of all medicines approved by the FDA’s Center for Drug Evaluation and Review during that time.)

Drug approval times, DiMasi and colleagues document, vary considerably by division. For example, median drug approval time at the fastest division, Oncology (which reviews cancer medicines), was 2-3x faster than at the Neurology and Cardiovascular/Renal divisions. Neurology took nearly 600 days to approve the median new drug, while Cardiovascular/Renal took over 400 days. The two fastest divisions (Oncology and Anti-Viral) took just under 200 days.

The authors accounted for division performance based on workload; type and complexity of drugs under review; and safety protocols used by drug reviewers. Surprisingly, they found that the high performers (Oncology and Anti-Viral) experience a relatively higher workload than other, seemingly less efficient divisions.

Overall, the oncology division was 60 percent faster, on average, in its approval process than other divisions taken as a whole. The authors suggest that if the FDA could reduce this performance gap by half—a relatively modest goal—the cost of developing a new drug would decline by $46 million dollars, or nearly $1 billion for the 19 non-oncology drugs approved every year.

These gains would, however, be minor in comparison to the gains to patients from increased investment and faster approval of more effective new medicines. Even after adopting conservative estimates for the value of a life-year ($150,000), if the FDA could significantly improve its efficiency and generate one additional generation of new drugs (20 or so) just one year earlier this would translate into $4 trillion in increased life-expectancy for patients.

The authors hope their findings will spur FDA leadership and policymakers to better understand, and expand, on “what works”. Broad patient engagement for HIV/AIDS and oncology medicines, flexible regulatory pathways first developed in the heat of the AIDS crisis, and rapid advances in the basic understanding of these diseases have all undoubtedly helped foster a regulatory environment which creates a virtuous cycle of innovation for cancer and HIV medicines.

Indeed, Commissioner Hamburg echoed these themes recently, in her call to expand the same regulatory tools—used for cancers and other rare diseases—for widespread chronic ailments. She called for shorter and smaller clinical trials (often used for testing cancer medicines), as we “apply many of these important new insights into how to streamline and modernize our regulatory system, bringing the best science to bear, and recognizing we don't [need] to have studies that have to wait for the whole natural history of the disease to unfold to [assess] how something works.”

In other words, inside the agency today, we already have an FDA that (in parts at least) understands how to apply emerging scientific insights to accelerate access to the most promising new medicines. Measuring, and understanding, how specific review divisions accomplish this is the first step in ensuring that best practices become “business as usual” for every drug review division.

Original Source: http://thehill.com/blogs/congress-blog/healthcare/204092-fda-measure-and-improve-thyself

 

 
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