RegLink Associates Welcomes FDA's First Draft Guidance on Risk Evaluation & Mitigation Submission (REMS)

RegLink Associates' Principal, Ansis Helmanis, welcomes FDA's first draft guidance to help companies better understand what is expected in risk evaluation and mitigation strategy submissions. Obligations to fund and support costly studies can extend beyond the date of exclusivity, giving follow-on competitors an advantage.

Washington, DC, April 01, 2010 --( In an article that appeared in the March 2010 issue of Pharmaceutical Executive, Ansis Helmanis, a Principal at RegLink Associates welcomed the guidance, adding that companies could also benefit from more practical guidance on the negotiation of REMS. The critical element is anticipating and evaluating the strategic and bottom-line impact on making long term commitments.

Most risk/benefit questions can be answered within the first 3-5 years of marketing experience with a new drug. The key issue is whether longer term postmarketing studies/trials are really needed.

The innovator could at substantial ongoing cost end up supplying to FDA trial results that in effect support continued marketing by follow-on competitors not bound by the same REMS obligations.

The best course of action before opening REMS negotiations with FDA is to take necessary steps to cover all bases. REMS commitments are not just a regulatory matter, and require a multi-disciplinary team.

Ansis specializes in corporate policy development. RegLink Associates is an innovative online resource for the weekly ‘What’s New’ worldwide in human and veterinary drugs and biologics and medical devices, as well as HTA developments.

Media Contact:
Ansis Helmanis, Esq.
RegLink Associates, LLC
Washington, DC

For more information, visit:

RegLink Associates
Ansis Helmanis