All Things Regulatory: Back to the Future? Not Likely for FDA Approvals

August 27, 2015 jim.merritt



Most people agree that hindsight can provide a valuable perspective. Marty McFly in the movie Back to the Future certainly learned a lot about his parents by going back in time. However, in the case of regulatory approvals, hindsight can be downright confusing when trying to predict the future.

Look at the flood of FDA approvals that took place last year when 44 new agents were approved, the most since 1996. That had many pharmaceutical executives hoping for a repeat in 2015; however, the pace this year is lagging.

This could be due to the PDUFA negotiation period, which we’ve just entered. Historically, new drug approvals by the Center for Drug Evaluation and Research (CDER) during the PDUFA negotiation period slow down. This may be because resources are redeployed to draft guidance documents, or because pharmaceutical companies are rushing to submit new agents before PDUFA incentives expire.

Another example of the past not predicting the future is last year’s approval of an obesity control device by the FDA’s Center for Devices and Radiological Health. The device was approved despite trials that failed to achieve their primary and secondary endpoints.

This had patient advocacy groups anticipating a similar relaxation of standards, especially for drugs for rare disorders, but a good look at history demonstrates that failure to achieve trial endpoints often leads to “refusal to file” decisions as well as complete response letters.

Improving the odds

Another reason biopharma companies may not be achieving approvals is the exodus of experienced talent taking place at many large and mid-size companies. A study by Tufts Center for the Study of Drug Development shows that many large and mid-size biopharma companies are reducing internal capacity and losing valuable experienced employees.

In order to strengthen the experience and capability of internal teams, many biopharma companies must turn to outsourcing to meet the need for supplemental resources and expertise, especially during times of peak demand such as preparation of regulatory submissions.

Outsourcing can expand the capability of internal teams, provide on-demand competency and fill capacity gaps, and provide experienced coaches and mentors for young talent and lean companies.

Next week, we’ll take a look at trends around data sharing and supply chain in pharma. For more information about trends in therapy and device approvals, download our eBook, “The Pharm-ers Almanac.


Authored By: Tim Franson, M.D., Chief Medical Officer at YourEncore; former VP Global Regulatory Affairs & Patient Safety, Eli Lilly and Company.

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