Submit good REMS proposals for FDA brownie points, says RAPS author

12-Jun-2012 - Last updated on 19-Aug-2020 at 08:45 GMT

Submitting a REMS (Risk Evaluation and Mitigation Strategies) proposal for risky drug developments could earn companies brownie points, according to Quintiles’ Ed Tabor.

The firm’s VP of strategic drug development wrote a book about the changes – first introduced in 2007 – for RAPS (Regulatory Affairs Professionals Society).

Speaking to in-PharmaTechnologist.com, he said the programme has the power to change how firms work with the FDA (US Food and Drug Administration).

“A good regulatory strategy always involves thinking ahead and using those predictions for strategic purposes,” he said.

“If a company has a drug under development, and they know it has a safety issue if they come to FDA with a REMS proposal that adequately addresses those it means that the review division is going to think of the company as proactively concerned about safety.”

He added proving your firm is concerned with safety for a drug under the approval process now could also earn brownie points in the future.

Tabor also spoke about the regulator’s current review process of the recently introduced programme.

And though the industry does not yet have the full seven year evaluation, he said the feeback so far has been positive.