CDER Ombudsman: Smaller Companies Feel Confusion, Pinch of Regulations

| 14 May 2012 | By Alexander Gaffney, RAC 

A report released by the Ombudsman's Office of the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) for 2011 says smaller companies are contacting it more because they are confused about which regulations apply to them and have more to lose from an adverse decision than do larger companies.

Most of the commercial companies contacting the CDER Ombudsman, which mediates disagreements between the agency and outside entities, were "smaller, emerging biotechnology and pharmaceutical companies," explained the Ombudsman's office.

The office noted it often receives pleas for assistance from smaller companies, who may be unfamiliar with regulations or grappling with how regulations apply to their specific products. The novelty of many smaller companies' products is a contributing factor in this, said the Ombudsman.

"Smaller companies often develop novel drug and biotechnology products that have no established regulatory path," wrote the Ombudsman. "Though welcome, this can be a challenge both for CDER and companies during development and review."

The report also details the stark choice many companies feel when preparing to disagree with a CDER decision.

"Though a disagreement between a company and CDER is not desirable for any company, small companies postulated (to the Ombudsman) that the short-term financial fitness of a small company might be more at risk," explained the Ombudsman. "Therefore, any rapid means of resolving a dispute, including contacting the CDER Ombudsman, is a preferred option."

Read more:

FDA Ombudsman - 2011 Annual Report (h/t FDA Law Blog)