Regulatory Focus™ > News Articles > FDA Looks to Surge Approach to Complete DESI Reviews

FDA Looks to Surge Approach to Complete DESI Reviews

Posted 10 April 2014 | By Alexander Gaffney, RAC 

In the US, as many as several thousand drugs are currently marketed without ever having received approval from the US Food and Drug Administration (FDA) as being effective for their intended purpose.

While many of these drugs are simply illegal, there are others that remain on the market legally despite never having received approval.

The History of Pharmaceutical Law in the US

To understand why is to understand the evolving history of federal pharmaceutical law in the US, and in particular the Federal Food, Drug and Cosmetic Act (FD&C Act), which was first passed in 1938 to require pharmaceutical products to provide evidence of their safety to federal regulators. The passage followed the deaths of dozens of children who had a drug laced with diethylene glycol, a chemical found in antifreeze.

More than two decades later, in 1962, legislators once again updated the FD&C Act (the Kefauver-Harris Amendments) to require sponsors of new drugs to provide substantial evidence of safety and the efficacy of their drug products.

But that requirement only applied to new drugs, and in the decades between 1938 and 1962 FDA signed off on the safety of thousands-perhaps tens of thousands-of new drugs. Older drugs could remain on the market until they were re-reviewed so long as they were not substantially changed-i.e. identical, related or similar (IRS) to a drug already approved for marketing.

In other words, updates to the law created two classes of approved drugs: Those that had obtained approval based on evidence of safety and efficacy, and those that were only known to be safe.

Reviewing Older Drugs: The Case of DESI

This situation was far from ideal for FDA regulators, who implemented a program known as the Drug Efficacy Study Implementation (DESI) to review the safety and efficacy of many of those drugs.

But DESI never got around to looking at every single drug product, and quite a few still remain on the market. By 2006, FDA said it wanted to try to wrap up its reviews through a new effort known as the Unapproved Drugs Initiative. Under the project, FDA said it would begin a systematic review of all drugs remaining on the market nearly 50 years after the start of the DESI program. The goal: Figure out how many unapproved drugs remain on the market, to evaluate those drugs, and to determine if they are effective. If so, they would need to be marketed under a New Drug Application (NDA).

But those reviews take time, money and resources. And according to a recent posting by FDA, they require something else as well: lawyers.

A 9 April 2014 posting on the Federal Business Opportunities (FBO) website calls for the assistance of legal experts-people with "proven experience, expertise, knowledge and abilities"-who can help the agency navigate the stubborn remaining few DESI reviews

As FDA explains in its contract solicitation: "The vast majority of the DESI proceedings have been concluded, but a few are still pending.  The pending nature of these proceedings allows manufacturers to continue to market often ineffective drug products.  Legal review of the administrative records is required for the remaining pending DESI proceedings to identify and evaluate the regulatory status of these products, and draft Federal Register notices to appropriately close-out these remaining DESI proceedings."

The legal experts brought on board would be tasked with reviewing documents, developing approaches to closing out DESI proceedings, drafting enforcement actions and providing legal support to FDA staff.

Proposals are due to FDA by 5 May 2014, FDA said.


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